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Study Objectives
The purpose of this study to develop an international tool that can be used to assess burden of disease in patients enrolled in the W\&W program for rectal cancer
Conditions: Rectal Cancer
Intervention / Treatment:
OTHER: Delphi exercise
| Inclusion Criteria:
* Patients have to be treated with neoadjuvant (chemo)radiotherapy
* Patients are included into the Watch-and-Wait program
* Experts involved in the treatment of rectal cancer
* Experts involved in the Watch-and-Wait program
Exclusion Criteria:
* Regrowth of disease | 12,296 |
Study Objectives
The goal of this clinical research study is to learn if CC-4047 (now called pomalidomide) and prednisone can help to control MMM. The safety of this therapy will also be studied.
Conditions: Polycythemia Vera, Thrombocythemia
Intervention / Treatment:
DRUG: CC-4047, DRUG: Prednisone, DRUG: CC-4047
| Inclusion Criteria:
* Must be >= 18 years of age at the time of voluntarily signing an Institutional Review Board/Independent Ethics Committee (IRB/IEC) - approved informed consent form.* Must be diagnosed with myelofibrosis requiring therapy including myelofibrosis with myeloid metaplasia (MMM), de novo presentation (i.e. agnogenic myeloid metaplasia \[AMMM\], and developing after an antecedent history of Polycythemia vera (i.e., post-polycythemic myeloid metaplasia \[PPMM\]), or essential Polycythemia (i.e., post thrombocythemic myeloid metaplasia \[PTMM\]).* Screening total hemoglobin level < 10 g/dL or transfusion-dependent anemia defined as per International Working Group (IWG) criteria (transfusion dependency defined by a history of a least 2 units of red blood cell transfusions in the last 28 days for hemoglobin < 8.5 g/dL that was not associated with overt bleeding)* Must have adequate organ function as demonstrated by the following <= 14 days prior to starting study drug: ·Alanine transaminase (ALT) (SGOT) and Aspartate aminotransferase (AST) (SGPT) <= 3 x upper limit of normal (ULN), \[unless upon judgment of the treating physician, it is believed to be due to extramedullary hematopoiesis (EMH)\] ·Total bilirubin < 3 x ULN or Direct Bilirubin < 2 x ULN ·Serum creatinine <= 2.5 mg/dL ·Absolute neutrophil count >= 1,000/µL (>=1.0 x 10\^9/L) ·Platelet count >= 50,000/µL (>=50 x 10\^9/L)* Subjects must be willing to receive transfusion of blood products* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 at screening.* Must be willing to adhere to the study visit schedule and other protocol requirements.* No active malignancies with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma (in situ) of the cervix or breast* All study participants must be registered into the mandatory POMALYST REMS™ program, and be willing and able to comply with the requirements of the POMALYST REMS™ program.* Females of reproductive potential (FCBP†) must adhere to the scheduled pregnancy testing as required in the POMALYST REMS™ program. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
Exclusion Criteria:
* Known positive status for HIV, hepatitis B carrier, or active hepatitis C infection.* The use of any growth factors, cytotoxic chemotherapeutic agents (e.g. hydroxyurea), corticosteroids, or experimental drug or therapy within 14 days of starting CC-4047 and/or lack of recovery from all toxicity from previous therapy to grade 1 or better.* Any serious medical condition or psychiatric illness that would prevent, (as judged by the treating physician) the subject from signing the informed consent form or any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.* Pregnant or lactating females* Prior use of CC-4047* Currently enrolled on another clinical trial or receiving investigational agent | 28,267 |
Study Objectives
Cirrhotic patients may be at high risk for esophageal cancer. Endoscopic resection is the standard treatment for superficial tumors. However, cirrhosis might be associated with upper gastrointestinal bleeding, particularly in case of portal hypertension or coagulopathy. This study aims to assess safety, efficacy and methods to prevent potential complications in cirrhosis or portal hypertension context for esophageal endoscopic resection.
This retrospective multicentric French-Belgian study includes all consecutive patients with cirrhosis or portal hypertension who underwent esophageal endoscopic resection from January 2005 to 2021.
Conditions: Esophageal Neoplasms, Cirrhosis, Portal Hypertension
Intervention / Treatment:
PROCEDURE: Endosocpic resection of early esophageal tumor
| Inclusion Criteria:
* older than 18 years with cirrhosis or portal hypertension who underwent endoscopic resection of an early esophageal tumor
Exclusion Criteria:
* younger than 18 | 25,986 |
Study Objectives
This is a phase II, single-group pilot study to evaluate efficacy and methylation. This study's overarching aim is to evaluate the systemic effects of black raspberries in patients with myelodysplastic syndrome or myelodysplastic syndrome/myeloproliferative neoplasm. Twenty-one patients with MDS will be treated with 25 gm (2x/day) of BRB powder taken orally.
Conditions: Myelodysplastic Syndromes
Intervention / Treatment:
DRUG: Freeze-Dried Black Raspberry Powder
| Inclusion Criteria:
* Patients must have a confirmed diagnosis of myelodysplastic syndrome or myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) proven by bone marrow biopsy/aspirate.* Patients with cytopenias (blood cell counts lower than the institutional lower limit of normal within the eight weeks prior to the study) who are receiving or received:
* red blood cell transfusions
* observation
* platelet transfusions
* erythropoietin
* granulocyte colony-stimulating factors
* granulocyte-macrophage colony-stimulating factors
* hydrea* Age >18 years.* Predicted life expectancy of at least 12 weeks.* Patients should be expected to stay on the same therapy for the period of the study.* Patients who do not have an indication for and/or are unable to tolerate a hypomethylating agent are eligible for the study.* Reproductive requirements:
Female patients must meet one of the following:
* Postmenopausal for at least one year before the screening visit, or
* Surgically sterile, or
* If women are of childbearing potential, agree to practice two effective methods of contraception from the time of signing of the informed consent form through 30 days after the last dose of study drug, AND
* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, or
* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, postovulation methods\] and withdrawal are not acceptable contraception methods.)
Male patients, even if surgically sterilized (i.e., status postvasectomy), must agree to one of the following:
* Practice effective barrier contraception during the entire study treatment period and through 30 days after the last study drug dose, OR
* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR
* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, postovulation methods\] and withdrawal are not acceptable methods of contraception.)* Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria:
A potential subject who meets any of the following exclusion criteria is ineligible to participate in the study.
* Previously received hypomethylating agents.* Allergy to black raspberries.* Inability to swallow oral medication.* Inability or unwillingness to comply with the BRB administration requirements.* Uncontrolled intercurrent illness, including, but not limited to, symptomatic congestive heart failure, or psychiatric illness/social situations, that, in the treating investigator's discretion, would limit compliance with study requirements.* Active infection not well controlled by antibacterial or antiviral therapy.* Pregnant or lactating women.* Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial. | 19,286 |
Study Objectives
RATIONALE: Vaccines made from a patient's white blood cells (dendritic cells) and a specific leukemia antigen (Wilms tumor antigen-1) may induce an effective immune response to kill residual leukemic cells and/or prevent leukemia relapse.
PURPOSE: This phase I/II trial is studying the feasibility, safety and efficacy of intradermal mRNA-transfected dendritic cell vaccination therapy in patients with acute myeloid leukemia.
Conditions: Acute Myeloid Leukemia (AML)
Intervention / Treatment:
BIOLOGICAL: injection of antigen-loaded cultured dendritic cells
| Inclusion Criteria:
* Tumor type: Acute Myeloid Leukemia (AML) according to the WHO criteria (ea at least 20% blasts in the marrow). All FAB subtypes except M3. Patients with Myelodysplastic Syndrome, category of Refractory Anemia with Excess Blasts (RAEB): RAEB I (WHO: medullary blast count ≤ 10% and a peripheral blast count ≤ 5%) and RAEB II (WHO: medullary blast count > 10% and/or > 5% peripheral blasts) can be included in the study in absence of other non-experimental treatment modalities.* Extent of disease: remission (partial or complete) or smouldering course. Complete remission (CR) is defined as no blasts in the peripheral blood and no more than 5% blasts in the bone marrow. This definition is related to the hematological remission if it is not specified. Partial remission (PR) is defined as a decrease of at least 50% in the percentage of blasts to 5 to 25% in the bone marrow aspirate. Smouldering course is defined as a relatively low marrow blast count and slowly progressive disease.* Overexpression of WT1 RNA (>50 copies of WT1 per 1000 copies ABL in bone marrow or >2 copy/1000 copies ABL in peripheral blood) as assessed by quantitative RT-PCR at the time of presentation.* Prior treatments : Patients must have received at least one prior antileukemic chemotherapeutic regimen and must be more than 1 month past the last treatment and/or 6 months past allogeneic/autologous stem cell transplantation.* Age: ≥ 18 years* High risk of relapse because of (and/or)
* Age > 60 years (if <60 y, no sibling allotransplant donor available)
* Poor risk cytogenetic or molecular markers at presentation
* Hyperleukocytosis at presentation
* Second complete remission after relapse* Performance status: WHO PS grade 0-1 (Appendix B)* Objectively assessable parameters of life expectancy: more than 3 months* Prior and concomitant associated diseases allowed with the exception of underlying autoimmune disease and positive serology for HIV/HBV/HCV* No concomitant use of immunosuppressive drugs* Adequate renal and liver function, i.e. creatinin and bilirubin = 1.2 times the upper limit of normal* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial* Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation
Exclusion Criteria:
* Subjects with concurrent additional malignancy (with exception of Non-melanoma skin cancers and carcinoma in situ of the cervix)* Subjects who are pregnant* Subjects who have sensitivity to drugs that provide local anesthesia* Age < 18 years | 9,016 |
Study Objectives
The purpose of this study is to characterize the pharmacokinetics/pharmacodynamics (PK/PD) of darbepoetin alfa administered at a subcutaneous (SC) dose of 0.45 mcg/kg three times weekly (TIW) in anemic patients with non-myeloid malignancies receiving multicycle chemotherapy.
Conditions: Non-Myeloid Malignancies, Anemia, Cancer
Intervention / Treatment:
DRUG: Darbepoetin alfa
| Inclusion Criteria:
* Non-myeloid malignancy
* Currently receiving 3-week cyclic chemotherapy treatment with a minimum of 2 additional cycles of chemotherapy planned at the time of enrollment
* Anemia predominately due to cancer or chemotherapy (Hb >= 9.0 and < 11.0 g/dL) at the time of screening
* 18 years of age or older at the time of screening
* Eastern Cooperative Oncology Group (ECOG) score 0-2
* Adequate liver and kidney function Exclusion Criteria:
* Known primary hematologic disorder, which could cause anemia, other than non-myeloid malignancies
* History of chronic myeloid leukemia (CML), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), acute lymphocytic leukemia (ALL), hairy cell leukemia, Burkitt's lymphoma, or lymphoblastic lymphoma
* Serum folate <= 2.0 ng/mL or vitamin B12 <= 200 pg/mL at screening (anemia related to nutritional deficiencies)
* Iron deficiency \[transferrin saturation (TSAT) < 15% and serum ferritin < 10 ng/mL\] at screening
* Other diagnoses not related to cancer or chemotherapy, which cause anemia (ie, hemolysis, bleeding, sickle cell anemia)
* Clinically significant inflammatory disease as determined by the investigator (eg, rheumatoid arthritis, Crohn's disease)
* Clinically significant co-morbid medical or psychiatric conditions that may impact subject safety or confound the ability to evaluate study endpoint as determined by the investigator
* Unstable or uncontrolled cardiac disease or condition (ie, angina, congestive heart failure, or cardiac arrhythmia)
* Diastolic blood pressure > 100 mmHg at screening
* Known hypersensitivity of erythropoietic-stimulating proteins (ESPs) or any excipients
* Known history of pure red cell aplasia
* Known positive antibody response to an ESP
* Use of investigational agents not approved or any indication during the previous 30 days prior to enrollment
* ESP therapy (i.e., recombinant human erythropoietin \[rHuEPO\] or darbepoetin alfa) within 21 days prior to screening or between screening and the first dose of study drug
* RBC transfusion(s) within 21 days prior to screening
* Pregnant or breast-feeding women - Previously enrolled in this study
* Known to be HIV, hepatitis B or C positive
* Any disorder that would compromise the ability of the subject to give written informed consent and comply with study requirements and procedures | 25,319 |
Study Objectives
The aims of this study are: (1) to assess the safety and activity of gemcitabine plus Alimta (pemetrexed) regimen (GA regimen) in patients with advanced NSCLC patients in the context of a randomized trial, and (2) to compare the GA with the paclitaxel plus gemcitabine (PG regimen) in terms of toxicity and QoL
Conditions: Non-Small Cell Lung Cancer, Stage IIIB or IV
Intervention / Treatment:
DRUG: gemcitabine plus pemetrexed, paclitaxel plus gemcitabine
| Inclusion Criteria:
* Patients with histologically or cytologically confirmed locally advanced (stage IIIB) or metastatic (stage IV) NSCLC* No previous adjuvant or palliative chemotherapy* No previous radiotherapy* Presence of at least one unidimensionally measurable lesion (Appendix 2)* ECOG performance status of 0 or 1 (Appendix 3)* Charlson score ≤ 2 (Appendix 4)* Adequate bone marrow function (absolute neutrophil count ≥ 2 x 109/L, platelet count ≥ 100 x 109/L, and hemoglobin level ≥ 100 g/L), and adequate liver function (bilirubin level < two times the upper limit of normal, AST and/or ALT < three times the upper limit of normal, prothrombin time < 1.5 times control), and creatinine clearance ≥ 60 ml/min.* Absence of symptomatic CNS metastases (patients with cerebral metastases treated with brain irradiation may be included), severe cardiac arrhythmia or heart failure, second or third degree heart block or acute myocardial infarction within 4 months prior to study entry.* No major surgery or pleurodesis within 14 days prior to enrollment.* Life expectancy of at least 12 weeks.* No previous or concurrent malignancy, except inactive non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer if the patient has been disease-free for more than 5 years.* Written informed consent
Exclusion Criteria:
* Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease).* Patients with clinically significant effusions.* Any other malignancies within 5 years that could affect therapy evaluation | 19,243 |
Study Objectives
Compare the response rate after 6 months of hormone treatment (or a major change in hormone treatment) in metastatic breast cancer, according to the uptake of FES in metastatic lesions taking-up FDG on PET/CT at baseline. Hypothesis: best response rate will be observed in patients with all metastases taking up FES prior to treatment.
Conditions: Metastatic Breast Cancer
Intervention / Treatment:
DRUG: Fluoroestradiol (18F)
| Inclusion Criteria:
* Post menopausal
* age > 17
* WHO 0-2
* Metastatic adenocarcinoma of the breast
* Treated by antihormone treatment during around 5 years withdrawn for at least 3 months OR metastatic cancer at diagnosis having received no more than one line of hormone treatment
* Life expectancy > 6 months
* Hormone-dependent cancer initially demonstrated by hormone receptors in the tumour
* Presence of oestrogen receptors proven with immunohistochemistry (> 10%) and HER2 determined by immunohistochemistry or FISH (on primary tumour or a metastasis)
* Metastatic recurrence on FDG PET dating less than 1 month, confirmed by another modality (contrast-enhanced CT, MRI, ultrasonography, bone scintigraphy or PET/CT, other)
* FDG PET/CT available on PACS or CD DICOM III format 11
* Informed consent obtained
Exclusion Criteria:
* Other evolutive malignant disease or acute or chronic infectious disease
* Chemotherapy during the last 3 months or change in treatment since FDG PET/CT.
* Isolated liver metastasis (high FES uptake by normal liver) | 3,964 |
Study Objectives
The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF in patients with breast cancer who were treated with intensive chemotherapy for prevention of neutrophil reduction.
Conditions: Breastcancer
Intervention / Treatment:
DRUG: PEG-rhG-CSF
| Inclusion Criteria:
*18-65 years old, gender no limited.
*Breast cancer diagnosed by pathology.
*Did not receive chemotherapy previously and plans to receive 4 cycles intensive EC (epirubicin, cyclophosphamide) treatment.
*No obvious blood system disease, ANC(absolute neutrophil count)≥ 1.5 × 10\^9/L, PLT(Platelet)≥80×10\^9 /L, Hb(hemoglobin)≥75g/L, WBC(White blood cell )≥3×109/L, and no bleeding tendency.
*KPS (Karnofsky performance status) score≥70.
*Expected survival≥3 months.
*Written informed consent are acquired.
Exclusion Criteria:
* Severe or uncontrolled infection.* Sensitive to the product or other genetically engineered biological products from Escherichia coli strains.* Mental or nervous system disorders.* Severe heart, lung and central nervous system disorders.* Pregnant or lactating women.* TBIL(total bilirubin ), ALT(alanine aminotransferase),AST(glutamic-oxalacetic transaminase) > 2.5×ULN(upper limit of normal); if it were caused by liver metastases, TBIL, ALT,AST >5×ULN.* Cr(creatinine) >1.5×ULN. | 2,855 |
Study Objectives
Sorafenib may stop the growth of cancer cells by blocking blood flow to the cancer and by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well sorafenib works in treating patients with chemosensitive recurrent aggressive non-Hodgkin's lymphoma
Conditions: Anaplastic Large Cell Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Mantle Cell Lymphoma
Intervention / Treatment:
DRUG: sorafenib tosylate, OTHER: laboratory biomarker analysis
| Inclusion Criteria:
* Histologically or cytologically confirmed aggressive\* non-Hodgkin's lymphoma by excisional-node biopsy or core needle biopsy and bone marrow biopsy, including 1 of the following types:
* Mantle cell lymphoma
* Primary mediastinal large B-cell lymphoma
* Diffuse large B-cell lymphoma
* Anaplastic large cell lymphoma (T-cell or null-cell type)
* Recurrent disease
* Patients must have received ≥ 1 induction regimen containing anthracyclines (e.g., CHOP \[with or without rituximab\] or R-EPOCH)
* Chemosensitive disease at the time of relapse
* Patients who responded with a complete or partial remission that lasted at least 8 weeks after their last chemotherapy regimen are considered chemosensitive
* Measurable disease, defined as a lymph node or a nodal mass of > 1 cm in its longest transverse diameter on CT scan
* Ineligible for, refused, or relapsed after stem cell transplant (for patients with non-mantle cell lymphoma)
* No known brain metastases, including meningeal involvement
* ECOG performance status (PS) 0-2
* Karnofsky PS 60-100%
* Life expectancy > 3 months
* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin normal
* AST and ALT ≤ 2.5 times upper limit of normal
* Creatinine normal OR creatinine clearance ≥ 60 mL/min
* Fertile patients must use effective contraception
* Not pregnant or nursing
* Negative pregnancy test
* No uncontrolled illness
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib
* No known positive HIV serology
* No inflammatory bowel disease
* No swallowing dysfunction that would prevent ingestion of pills
* No hemorrhagic diathesis
* No ongoing or active infection
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No uncontrolled hypertension
* No psychiatric or social situation that would limit compliance with study requirements
* No poorly controlled medical condition that would seriously complicate compliance with this study
* Patients with inflammatory or exfoliative skin disease are excluded (regardless of the extent of the involvement) unless the skin condition is lymphoma related
* See Disease Characteristics
* Previous treatment-related toxic effects should be resolved to grade 1 or better
* No chemotherapy or radiation therapy within the past 4 weeks
* 6 weeks for nitrosoureas or mitomycin C
* No prior antibody therapy for at least 3 months
* Prior radiation for localized disease or total body irradiation as part of a conditioning regimen prior to stem cell transplant allowed
* Prior radio-immunotherapy allowed
* No concurrent therapeutic anticoagulation
* Prophylactic anticoagulation (i.e., low-dose warfarin) of venous or arterial access devices are acceptable provided that the requirements for PT, INR, and PTT are met
* No concurrent use of another investigational agent
* No concurrent use of the following drugs: phenytoin, carbamazepine, phenobarbital, rifampin, or Hypericum perforatum (St. John's wort)
* No other concurrent anticancer therapy | 6,626 |
Study Objectives
This study is to explore risk factors for poor progression-free survival (PFS) and overall survival (OS) in ENKTL, and establish a prognostic model for ENKTL patients treated with non-anthracycline based treatment.
Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type
Intervention / Treatment:
| Inclusion Criteria:
* Patients diagnosed with ENKTL, nasal type
* Patients diagnosed between January 1, 1995 and December 31, 2014
* Patients treated with nonanthracycline-based therapy as the initial treatment after diagnosis
* Nonanthracycline-based therapy includes the following treatments:
* Radiotherapy including concurrent chemoradiation
* Chemotherapy not including anthracycline such as doxorubicin (e.g. SMILE, VIPD) The type of salvage treatment will not be a criterion for exclusion. Thus, patients who had received various kinds of salvage treatment including anthracycline-containing regimens can be included. Patients who had undergone autologous or allogeneic stem cell transplantation can also be included in the analysis if they satisfy the above-mentioned inclusion criteria.
Exclusion Criteria:
* Patients who had received anthracycline-based therapy, such as CHOP or CHOP-like regimens, as the initial treatment.
* Patients who do not have pathology slides available for central review. | 24,056 |
Study Objectives
The purpose of this study is to evaluate the safety of non small cell lung cancer (NSCLC) treatment with cisplatin and oral vinorelbine administered weekly associated with concomitant radiotherapy in elderly patients.
Conditions: Non Small Cell Lung Cancer
Intervention / Treatment:
DRUG: Cisplatin IV, DRUG: Vinorelbine, RADIATION: Radiotherapy
| Inclusion Criteria:
* Age ≥ 70 years
* Independent patients (based on the score of geriatric frailty: IADL = 0, ADL = 0, no geriatric syndrome, low comorbidity (comorbidity index of Charlson to 3 or 4), depression score 0-1)
* Performance Status (ECOG) ≤ 1
* Weight loss <10% of usual weight in the last 3 months
* Life expectancy greater than 12 weeks
* Hematologic function: neutrophils> 1.5 x 10\*\*9 / l, hemoglobin> 9.5 g / dl, platelets > 100 x 10\*\*9 / l)
* Renal function: creatinine clearance ≥ 50 ml / min calculated by the formula of MDRD
* Normal liver function: bilirubin < Limit of Normal (ULN), SGOT and / or SGPT <2.5 x UNL
* Respiratory Function: FEV ≥ 40% predicted, PaO2 ≥ 60 mm Hg, KCO ≥ 60% predicted
* Patient affiliated to a social security regimen or beneficiary of such regimen
* Informed consent signed
The disease
* Pathological anatomy: CBP non-small cell (squamous cell carcinoma, adenocarcinoma, large cell carcinoma, undifferentiated carcinoma) histologically or cytologically proven
* Stage IIIAN2 considered inoperable stage IIIB
* Presence of at least one measurable target
* Delay at least three weeks between surgery and initiation of treatment
* No prior treatment with chemotherapy or radiotherapy for lung cancer
Exclusion Criteria:
* Age < 70 years
* Performance Status (ECOG) ≥ 2
* Hematologic function: neutrophils <1.5 x 10\*\*9 / l, hemoglobin <9.5 g / dl, platelets <100 x 10\*\*9 / l)
* Renal function: creatinine clearance <50 ml / min calculated by the formula of MDRD
* Hepatic: bilirubin> Upper Limit of Normal (ULN), SGOT and / or SGPT> 2.5 x ULN
* Respiratory Function: FEV <40% predicted, KCO <60% predicted, PaO2 <60 mmHg
* Peripheral neuropathy grade> 1
* Unstable cardiac pathology requiring treatment (heart failure, angor of effort, arrhythmia) or previous myocardial infarction older than 12 months
* Deafness not paired or deafness requiring major achievement of an audiogram-cons may indicate taking cisplatin
* Neurological or psychiatric disorders prohibiting the understanding of the test
* Previous history of cancer except basal cell cancer, carcinoma in situ of the cervix treated or any other cancer treated with surgery alone or radiotherapy alone extra-thoracic recurrence-free 5 years
* Significant malabsorption syndrome or disease affecting the functioning of the gastrointestinal tract
The disease
* Pathological anatomy: Bronchioloalveolar carcinoma, neuroendocrine carcinoma, small cell carcinoma
* Metastatic disease
* Pleural drain
* Carcinomatous lymphangitis
* Operable Cancer
* Previously treated for lung cancer disease: radiotherapy, chemotherapy, hormonal therapy, endobronchial suctioning older less than eight days | 35,899 |
Study Objectives
This phase I trial studies the side effects and best dose of veliparib when given together with radiation therapy in treating patients with advanced solid malignancies (abnormal cells divide without control and can invade nearby tissues) with peritoneal carcinomatosis, epithelial ovarian, fallopian, or primary peritoneal cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x rays to kill tumor cells. Giving veliparib with radiation therapy may kill more tumor cells.
Conditions: Adult Solid Neoplasm, Peritoneal Carcinomatosis, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
Intervention / Treatment:
OTHER: Laboratory Biomarker Analysis, OTHER: Quality-of-Life Assessment, RADIATION: Radiation Therapy, DRUG: Veliparib
| Inclusion Criteria:
* Dose levels 1-4 must have histologically proven solid malignancy that is metastatic or unresectable with metastatic peritoneal carcinomatosis; as this entity may be difficult to image, peritoneal disease can be documented through other modalities such as operative notes, clinical notes/symptoms, etc as well as imaging
* Dose levels 5 and 6 will be open only to patients with recurrent or persistent primary epithelial ovarian, fallopian or peritoneal cancers; at these dose levels, measurable disease in the abdominal cavity must be present but peritoneal carcinomatosis is not required for eligibility
* Patients must have failed first line standard therapy or have no acceptable standard treatment options; for patients on dose levels 5 and 6, patients may be platinum sensitive, platinum resistant or platinum refractory
* Ability to understand and the willingness to sign a written informed consent document
* Eastern Cooperative Oncology Group (ECOG) performance status =< 1
* Life expectancy of greater than 3 months
* Absolute neutrophil count (ANC) >= 1,500/mcL
* Platelets >= 100,000/mcL
* Total bilirubin =< 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =< 2.5 x ULN
* Creatinine =< 1.5 x ULN OR creatinine clearance >= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
* Calcium within normal limit (WNL)
* No surgery, hormonal therapy or chemotherapy within four weeks; for dose levels 5 and 6, patients receiving mitomycin C or nitrosoureas must discontinue treatment 6 weeks prior to registration and any hormonal treatment directed at the malignant tumor must be discontinued at least one week prior to registration; continuation of hormone replacement therapy is permitted
* No previous abdominal radiation; if the patient has received previous pelvic radiation there should not be any overlap between the current and previous radiation fields
* Toxicities of prior chemotherapy recovered to grade 1 or less except for stable grade 2 peripheral neuropathy
* Negative pregnancy test if premenopausal; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
* Archival tumor sample collection with a tumor block is required for all enrolled patients when available; this will not be required for patients on dose levels 5 and 6; if no block can be released per institutional policy, 10 to 20 unstained slides may be substituted; slides should have a positive charge and a thickness of 3 to 5 microns; if the only tissue sample available is a fine needle aspirate (FNA), the patient will still be considered eligible
* Patients with central nervous system (CNS) metastases to be stable after therapy for > 3 months and off steroid treatment prior to study enrollment
* For patients in dose levels 5 and 6, BRCA testing results, if previously performed, should be attained; if no BRCA testing has been performed, patients may be referred to a genetic counselor and will have detailed family history performed as part of the screening process
Exclusion Criteria:
* Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
* Patients who are currently receiving any other investigational agents
* Brain metastases: patients with treated and stable brain metastasis for 3 months, off steroids will be eligible
* Patients who demonstrate any clinical evidence of bleeding
* Patients who have demonstrated an inability to swallow oral medications
* Patients who currently have an active gastrointestinal obstruction, have had a gastrointestinal obstruction within the last 30 days prior to enrollment and/or are actively requiring parenteral nutrition are excluded; patients who have had a history of any prior gastrointestinal obstruction requiring surgical intervention are also excluded
* Patients who have a known hypersensitivity to the components of the study drug, its analogs or drugs of a similar chemical or biologic composition
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with veliparib
* Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
* Patients who have uncontrolled ascites
* Patients with active seizures or a history of seizure are not eligible
* Patients previously treated with poly (ADP-ribose) polymerase 1 (PARP) inhibitors | 21,583 |
Study Objectives
This study will evaluate whether NKTR-102, an investigational drug has an anti-tumor effect in patients with colorectal cancer. This study will also evaluate how the safety and anti-tumor activity of NKTR-102 compares with irinotecan, a cancer drug that is approved for use in the US for treatment of patients with certain types of colorectal cancer.
Conditions: Colorectal Cancer
Intervention / Treatment:
DRUG: NKTR-102, DRUG: irinotecan
| Inclusion Criteria:
* metastatic colorectal cancer
* tumor with k-ras mutation
Exclusion Criteria:
* More than 1 prior regimen for treatment of metastatic disease | 22,946 |
Study Objectives
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Iloprost may be effective in preventing lung cancer.
PURPOSE: This randomized phase II trial is studying how well iloprost works in preventing lung cancer in patients who are at high risk for this disease.
Conditions: Lung Cancer, Precancerous Condition
Intervention / Treatment:
DRUG: iloprost, OTHER: placebo
| Inclusion Criteria:
* Current or former smoker with ≥ 20 pack-year history of smoking with no tobacco use within the past 6 months
* Mild atypia or worse on sputum cytology, or
* Bronchial biopsy with mild or worse dysplasia within the past 12 months
* Age 18 and over
* SWOG (Southwest Oncology Group)0-2
* Life expectancy at least 6 months
* Granulocyte count > 1,500/mm\^3
* Platelet count > 100,000/mm\^3
* Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
* Transaminases ≤ 2.5 times ULN
* Bilirubin ≤ 2.0 mg/dL
* Albumin ≥ 2.5 g/dL
* Creatinine ≤ 1.5 mg/dL
* Well-controlled atrial fibrillation OR rare (< 2 minutes) premature ventricular contractions allowed
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able and willing to undergo bronchoscopy
Exclusion Criteria
* Clinically apparent bleeding diathesis
* Ventricular tachycardia
* Multifocal premature ventricular contractions or supraventricular tachycardias with rapid ventricular response
* Pneumonia or acute bronchitis within the past 2 weeks
* Hypoxemia (< 90% saturation with supplemental oxygen)
* Pregnant or nursing
* Malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* Serious medical condition that would preclude bronchoscopy or study participation
* Clinically active coronary artery disease
* Myocardial infarction within the past 6 weeks
* Chest pain
* Congestive heart failure
* Cardiac dysrhythmia that is potentially life-threatening
Exclusion for PRIOR CONCURRENT THERAPY:
* Biologic therapy (Not specified)
* More than 5 years since prior chemotherapy
* More than 6 weeks since prior inhaled steroids
* More than 5 years since prior thoracic radiotherapy
* Surgery (Not specified)
* No prior prostacyclin | 35,243 |
Study Objectives
The purpose of this study is to evaluate the association between wearable biosensor data, performance status and patient-reported outcomes in cancer patients. Participants in this study will wear a biosensor (Fitbit Charge HR®) for 15 days and respond to questionnaires that will assess patient reported outcome measures including physical function, emotional distress, pain interference, sleep disturbance and fatigue.
Eligible patients will have a diagnosis of advanced cancer. Patients must be greater than 18 years of age and be English speaking due to the questionnaires that will be administered during the study. Patients must also be ambulatory (use of walking aids, such as cane and rollator, is acceptable) and have access to a smartphone with internet access (IOS or Android). It is also necessary for patients to have scheduled oncology clinic visits at least once every 2 weeks.
Conditions: Neoplasms
Intervention / Treatment:
DEVICE: Fitbit Charge HR®
| Inclusion Criteria:
* Diagnosis of advanced solid malignancy (Stage 3 or 4) with measurable disease, who are being followed by an oncologist
* 18 years or older
* English speaking
* Ambulatory (use of walking aids, such as cane and rollator, is acceptable)
* Access to IOS or Android smartphone with internet access
* Expected to have oncology clinic visits at least once every 2 weeks
* Have an understanding, ability, and willingness to fully comply with study procedures and restrictions
* Ability to consent
Exclusion Criteria:
* Allergy to surgical steel or elastomer/rubber
* Using a pacemaker, implantable cardiac defibrillator, neurostimulator, hearing aids, cochlear implants, or other electronic medical equipment | 18,927 |
Study Objectives
Introduction High dose chemotherapy followed by Autologous Stem Cell Transplantation (ASCT) is a therapeutic option in follicular Lymphoma after first line treatment failure. The clinical characteristics and outcome of FL patients who relapsed after HDT+ASCT and therapeutic management in the rituximab era are not well known and may represent a difficult challenge.
Patients and Methods: The investigators conducted a retrospective analysis of FL patients who relapsed after HDT+ASCT in four French centers treated between 2000 and 2014. Clinical records were reviewed for clinical characteristics and treatment strategy at relapse. The investigators aimed to identify prognostic factors related to patient's outcome.
Conditions: Patient's Outcome Prognostic Factors
Intervention / Treatment:
| Inclusion Criteria:
* they were older than 18 years
* presented FL at diagnosis (Grade 1, 2, or 3a).
* received high-dose therapy (HDT) with ASCT from 2000 to 2014
Exclusion Criteria:
* they had already been treated with a 1st ASCT,* had a previous history of histological transformation before ASCT* if they were rituximab naive prior to ASCT. | 1,527 |
Study Objectives
The primary objectives are to determine the progression-free survival (PFS) and to evaluate safety of the trastuzumab, bevacizumab and docetaxel regimen.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Trastuzumab, DRUG: Bevacizumab, DRUG: Docetaxel
| Inclusion Criteria:
* Histologically confirmed breast cancer with evidence of metastatic disease
* HER2 3+ or FISH (fluorescent in situ hybridization)+
* Age ≥ 18 years
* No prior trastuzumab, except as given in the adjuvant or neoadjuvant setting.
* No prior chemotherapy in the metastatic setting.
Exclusion Criteria:
* CNS (central nervous system) metastases
* Prior radiation therapy within the last 4 weeks
* Pregnant (positive pregnancy test) or lactating women
* Major surgical procedure, open biopsy, non-healing wounds, or significant traumatic injury within 28 days prior to starting study or anticipation of need for major surgical procedure during the study
* Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to start of study. | 16,169 |
Study Objectives
To document pre-diagnosis educational abilities, to document any change in educational achievements following treatment, to document educational support given within the statement process and to document the timing of support.
Conditions: Brain Tumour
Intervention / Treatment:
| Inclusion Criteria:
* patients/parental consent for RMH accessing educational information from them and their school
* patients with a primary brain tumour
Exclusion Criteria:
* children with secondary brain tumours
* children who have had treatment for a relapse of primary brain tumour | 10,173 |
Study Objectives
The primary purpose of your participation in this study is to help answer the following research questions, and not to provide you treatment for your condition.
* To assess how well treatment with pemetrexed works for patients with your type of cancer
* To assess for any side effects that might be associated with pemetrexed.
* To look at the characteristics and levels of certain of your genes and proteins to learn more about osteosarcoma and how pemetrexed works in your body.
Conditions: Osteosarcoma
Intervention / Treatment:
DRUG: Pemetrexed
| Inclusion Criteria:
* Histological diagnosis of high grade locally advanced or metastatic osteosarcoma
* Must have one prior chemotherapy regimen for advanced disease
* At least 1 unidimensional measurable lesion by computed tomography (CT) scan
* Have a good performance status
* Adequate organ function
Exclusion Criteria:
* Have a serious concomitant systemic disorder (for example active Human Immunodeficiency Virus infection)
* Have brain metastases not adequately treated
* Significant weight loss (that is more than 20%) over the previous 6 weeks before study entry
* Inability or unwillingness to take folic acid or vitamin B12 supplementation and corticosteroids
* Pregnant or breast-feeding | 24,355 |
Study Objectives
This study is open to patients with primary HCC who cannot be treated by potentially curative treatment modalities, such as surgical resection, liver transplantation or percutaneous ablation.
Patients that satisfy the study eligibility criteria will be randomised in a 1: 1 ratio to receive either Radioembolisation with SIR-Spheres Microspheres or the standardised Transarterial Chemoembolisation procedure.
Study Objectives
This study will evaluate and compare quality of life as well as safety and efficacy of RE or TACE in patients with unresectable HCC. Patients will be followed for a minimum of 12 months or until death wherever possible in the evaluation of the primary and secondary objectives of this study.
Conditions: Hepatocellular Carcinoma
Intervention / Treatment:
DEVICE: Radioembolisation (SIR-Spheres® microspheres), DRUG: Transarterial Chemoembolisation
| Inclusion Criteria:
* Male or female patients, aged ≥ 18 years
* Unequivocal diagnosis of primary HCC (confirmed by biopsy/histology or EASL criteria)
* Tumour characteristics as follows:
* Not more than 5 lesions
* If single, maximal diameter ≤ 10 cm
* If multiple, sum of maximal diameters ≤ 15 cm
* Lesions satellite to primary tumour of less than 1 cm in maximal diameter are not included
* At least one quantifiable lesion on hepatic MRI
* Preserved liver function, corresponding to Child-Pugh class ≤ B-7
* ECOG performance status ≤ 2
* Life expectancy ≥ 12 weeks
* Female patients of childbearing potential must have a negative pregnancy test prior to inclusion in the trial and male and female patients must agree to use an effective contraceptive method for the duration of the trial.
* Willing and able to provide written informed consent
Exclusion Criteria:
* Patients expected to undergo surgery (resection or transplantation) within the 24-week period after randomisation.
* Ascites, which is detectable on physical examination or clinically symptomatic (but patients having ascites discovered by imaging only should not be excluded).
* Serum transaminases > 5 x ULN
* Lung shunt > 20%
* Extrahepatic disease
* Moderate to severe portal hypertension, as evidenced by any of the following criteria (occurring in spite of using common criteria for prophylactic treatment and therapy):
* History of variceal haemorrhage in past 2 years
* History of hepatic encephalopathy
* Platelets < 50.000 /ml
* WBC < 3.000 / ml
* Previous TIPSS procedure
* Portal vein occlusion or hepatofugal flow.
* Impaired liver function
* Total serum bilirubin > 2.0 mg / dL
* Serum albumin < 3.0 g /dl
* creatinine > 2 mg / dL
* Chemotherapy or other experimental therapy within preceding 4 weeks
* Previous TAE / TACE
* Previous radiation therapy to liver or lungs
* Contraindications for angiography (severe peripheral vascular disease or uncorrectable bleeding diathesis)
* Anatomical variants apparent on 99mTc-MAA scan precluding safe administration of RE
* Any decompensated concomitant disease
* Female patients who are pregnant, breast-feeding, or pre-menopausal and not practising efficient contraceptive method (hormonal contraceptive, intra-uterine device) | 4,744 |
Study Objectives
The purpose of this post-marketing surveillance (PMS) study is to collect safety information on the use of Cervarix upon the expanded indication to anal cancer to both women and men (at least 600 Korean women and men) within 30 days after each vaccination dose, when administered according to the approved prescribing information (PI) in Korea in a real health care setting over a period of 4 years.
Conditions: Neoplasms, Rectal
Intervention / Treatment:
OTHER: Safety data collection (following routine vaccination) by a continuous surveillance method.
| Inclusion Criteria:
* Subject or/and subjects whose parent(s)/Legally Acceptable Representative(s) \[LAR(s)\], in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Korean male or female subjects aged 9-25 years who are eligible for the series of Cervarix according to the locally approved PI.
* Written informed consent obtained from the subject/from the parent(s)/LAR of the subject.
Exclusion Criteria:
* At the time of PMS entry, the contraindications and precautions of use indicated in the locally approved PI. PI should be checked and the subject must not be included in the PMS if there is any contraindication. Any changes in the locally approved PI must be implemented immediately.
* Subjects who had previous administration of a HPV vaccine other than Cervarix will not be enrolled into the study.
* Subjects who are not eligible for vaccination with Cervarix according to the medical judgement of physician.
* Child in care. | 3,610 |
Study Objectives
The purpose of this study is to test the drug RAD001 in combination with another chemotherapy drug, Carboplatin, as well as radiation therapy in the treatment of esophageal cancer. Because RAD001 has not been used in this combination before, it is not clear which dose will be best when used in combination.
The standard of care for patients who have esophageal cancer that has not moved to other areas of the body (non-metastatic) includes a combination of chemotherapy, radiation therapy and possibly surgery. If the patient chooses to participate in this study, the patient will receive chemotherapy and radiation therapy. The patient will possibly also have surgery to have the cancer removed. This decision will be made by the treating physicians. All of the chemotherapy the patient will receive on the study is considered standard chemotherapy for esophagus cancer. The investigators do not know as of yet if the drug called RAD001 will help improve the treatment for patients with this disease. RAD001 is a pill that has been used in many other types of cancer and has been proven to be effective in other cancers such as kidney cancer.
Conditions: Esophageal Cancer, Neoplasms, Esophageal
Intervention / Treatment:
DRUG: RAD001, DRUG: XELOX, DRUG: Carboplatin, RADIATION: Radiation
| Inclusion Criteria:
* Patients must have histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal (GE) junction.
* Patients can have disease that is resectable or unresectable.
* Patients must not have had prior chemotherapy or radiation therapy for esophageal cancer.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Age ≥ 18.
* Adequate bone marrow, liver and renal function as assessed by the following:
* Absolute neutrophil count (ANC) ≥ 1500/mm³.
* Platelet count ≥ 100,000/mm³.
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN).
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement).
* Creatinine ≤ 1.5 x ULN.
* Fasting serum cholesterol ≤ 300 mg/dL OR ≤ 7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
* Women of childbearing potential must have a negative pregnancy test prior to first receiving investigational product. Sexually active women of childbearing potential (WOCBP) must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized. All WOCBP should be instructed to contact the Investigator immediately if they suspect they might be pregnant (e.g., missed or late menstrual period) at any time during study participation.
* Patient must be willing to sign informed consent.
Exclusion Criteria:
* Patients currently receiving other investigational agents.
* Patients with known distant metastases.
* Patients who have received prior treatment with an mammalian target of rapamycin (mTOR) inhibitor (sirolimus, temsirolimus, everolimus).
* Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients.
* Known hypersensitivity to oxaliplatin, other platinum-containing compounds.
* Patients with known brain metastases.
* Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as a known history of HIV seropositivity.
* History of active hepatitis B or C.
* Co-administration with strong inhibitors of cytochrome P450 3A4 isoenzyme (CYP3A4) (e.g., ketoconazole, itraconazole, ritonavir) or P-glycoprotein (PgP).
* Patients with an active, bleeding diathesis.
* Patients with significant intercurrent medical illness (including New York Heart Association \[NYHA\] class III or IV heart disease, significant arrhythmias requiring medication, symptomatic coronary artery disease, myocardial infarction) within the previous 6 months. | 28,010 |
Study Objectives
The primary endpoint of this study is to estimate morphologic complete remission rate. Estimation of response rate is also a secondary objection.
Conditions: Myelodysplastic Syndromes
Intervention / Treatment:
DRUG: Azacitidine
| Inclusion Criteria:
* Pathological MDS either de novo or secondary, fitting any of the FAB classifications, confirmed by institutional pathologist within 2 weeks prior to start of treatment. Patients with 5% bone marrow blasts must also meet one of the following criteria:
* Symptomatic anemia with either hemoglobin less than 10.0 g/dL or requiring RBC transfusion
* Thrombocytopenia with a history of two or more platelet counts < 50,000 / µL or a significant hemorrhage requiring platelet transfusions, or
* Neutropenia with two or more absolute neutrophil counts less than 1,000 /µL.* ECOG performance status of 0-2.* Must give written informed consent indicating their awareness of the investigational nature of this study and its potential hazards.* Adequate renal and hepatic function (creatinine ≤ 150% of institutional upper limit of normal, total bilirubin ≤ 150% institutional upper limit of normal, AST ≤ 200% institutional upper limit of normal).* Life expectancy of at least 12 weeks.* Have not received any chemotherapy within 4 weeks of study enrollment and must have recovered from any treatment-related toxicities.* Women of childbearing age must have a negative serum pregnancy test prior to initiating therapy.* Sexually active women of childbearing potential must use effective birth control during the trial and for an appropriate period after the trial.* Men must be willing to avoid fathering a new child while receiving therapy with azacitidine.* ≥18 years, no upper age limit* Individuals who are candidates for hematopoietic stem cell transplantation and who meet all other study criteria may participate in the study and receive intravenous azacitidine alone as a treatment prior to transplantation.
Exclusion Criteria:
* Known CNS leukemia.* Previously received Azacitidine (Vidaza®, Pharmion Corp., Boulder CO) or decitabine (Dacogen®, MGI Pharma Inc. Bloomington, MN).* Known or suspected hypersensitivity to azacitidine or mannitol.* Receiving any other investigational agents within 30 days of first dose of study drug.* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congestive heart failure of NYHA class 3 or 4, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.* Known positive serology for HIV.* Had radiotherapy within 14 days prior to study enrollment.* Known presence of hepatic tumors.* <18 years of age* Exclude women who are pregnant or breast feeding. | 22,576 |
Study Objectives
This study was to evaluate the efficacy and safety of single agent oral panobinostat in patients who have refractory de novo or refractory secondary AML.
Conditions: Refractory Leukemia, Acute Myelogenous Leukemia
Intervention / Treatment:
DRUG: Panobinostat/LBH589
| Inclusion Criteria:
* Written informed consent prior to study-specific screening procedures
* Life expectancy of ≥ 60 days
* Eastern Cooperative Group (ECOG) performance status ≤ 2
* Refractory AML with confirmed initial diagnosis of de novo AML (excluding APL) - OR- Refractory AML with confirmed initial diagnosis of AML (excluding APL) secondary to AHD or MDS with either condition precedent to AML (MDS/AHD)
* Negative serum pregnancy test (within 7 days of first dose)
* Negative urine pregnancy test immediately prior to first dose
Exclusion Criteria:
* Known HIV
* Psychiatric disorder that interfered with ability to understand the study and give informed consent, and/or would impact study participation or follow-up
* Concurrent use of medications that might prolong the QT interval or of inducing Torsade de Pointes
* Female patients who were pregnant or breast-feeding or patients of childbearing potential who were not willing to use a double barrier method of contraception during the study and for 3 months following the last dose of study drug.
* Male patients whose sexual partner(s) were women of childbearing potential who were not willing to use a double method of contraception, one of which included a condom, during the study and for 3 months after the end of treatment
* Patient unable to swallow capsules
* Patients with impaired gastrointestinal systems which might cause interference with digesting and absorbing panobinostat
Other Protocol-defined inclusion/exclusion criteria may apply | 11,872 |
Study Objectives
This is an open label, dose escalation study to evaluate the safety and efficacy of intralesional injection of STP705 in adult patients with Cutaneous Squamous Cell Carcinoma in situ (isSCC, Bowen's disease). The purpose of this trial is to evaluate the safety, tolerability and efficacy of various doses of STP705 administered as Intralesional injection in subjects with isSCC.
Goals:
* To determine the safe and effective recommended dose of STP705 for the treatment of isSCC.
* Analysis of biomarkers common to isSCC formation pathway including TGF-β1 and COX-2.
Conditions: Bowen's Disease, Cutaneous Squamous Cell Carcinoma in Situ
Intervention / Treatment:
DRUG: STP705
| Inclusion Criteria:
* 1. Male or female adult ≥ 18 years of age.
* 2. Primary, histologically confirmed trunk or extremity (non-peri-orbital/-anogenital/-facial/-scalp) isSCC lesion suitable for excision with a minimum diameter of 0.5cm and with a maximum diameter of 2.0cm.
* 3. Histological diagnosis made no more than 6 months prior to the screening visit.
* 4. Histological biopsy removed ≤25% of the original area of the target lesion.
* 5. No other dermatological disease in the isSCC target site or surrounding area, which in the opinion of the investigator, could interfere with the study.
* 6. Willing to refrain from using non-approved lotions or creams on the target site and surrounding area during the treatment period.
* 7. Willing to refrain from exposure to excessive direct sunlight or ultraviolet light and to avoid the use of tanning parlors for the duration of the study.
* 8. Laboratory values for the tests (listed in the Study Schedule) within the reference ranges as defined by the central laboratory, or "out of range" test results that is clinically acceptable to the investigator. Acceptable "out of range" values are generally those within 2 standard deviations of the mean or explainable due to concurrent medications or disease processes.
* 9. Ability to follow study instructions and likely to complete all study requirements.
* 10. Written informed consent obtained, including consent for tissue to be examined and stored by the Central Histology Lab.
* 11. Written consent to allow photographs of the target isSCC lesion to be used as part of the study data and documentation.
* 12. For females of childbearing potential, a negative pregnancy test at screening and using an acceptable form of birth control (oral / implant/ injectable/ transdermal contraceptives, intrauterine device, condom, diaphragm, abstinence, or a monogamous relationship with a partner who has had a vasectomy).
Exclusion Criteria:
* 1. Pregnant or lactating.
* 2. Presence of known or suspected systemic cancer.
* 3. Histological evidence of nBCC, sBCC, invasive SCC, or any other non-isSCC tumor in the biopsy specimen.
* 4. Histological evidence of severe squamous metaplasia, infiltrative, desomoplastic or micronodular growth patterns in the biopsy specimen.
* 5. History of recurrence of the target isSCC lesion.
* 6. Prior exposure to STP705.
* 7. Evidence of dermatological disease or confounding skin condition in the treatment area, e.g., BCC, actinic keratosis, rosacea, psoriasis, atopic dermatitis, eczema, xeroderma pigmentosa.
* 8. Concurrent disease or treatment that suppresses the immune system;
* 9. Patients with baseline QTC > 480 msec using Frederica's formula
* 10. Chronic medical condition that in the judgment of the investigator(s) would interfere with the performance of the study or would place the patient at undue risk.
* 11. Known sensitivity to any of the ingredients in the study medication.
* 12. Use of a tanning beds or other excessive or prolonged exposure to ultraviolet light or direct sunlight during the study.
* 13. Treatment with systemic chemotherapeutic agents within the 6 months prior to the screening visit.
* 14. Use of systemic retinoids within the 6 months prior to the screening period.
* 15. Treatment with systemic immunomodulators or immunosuppressants within the 6 months prior to the screening period.
* 16. Use of topical immunomodulators within 2cm of the target isSCC lesion within the 4 weeks prior to the screening period.
* 17. Treatment with the following topical agents within 2cm of the target isSCC lesion within the 4 weeks prior to the screening visit: amino-levulanic acid, 5-fluorouracil, corticosteroids, retinoids, diclofenac, ingenol mebutate, or imiquimod.
* 18. Treatment with liquid nitrogen, surgical excision (excluding diagnostic incisional biopsy) or curettage within 2cm of the target isSCC lesion during the 4 weeks prior to the screening visit.
* 19. Elective surgery within 4 weeks prior to the screening visit, during the study, or 4 weeks after the study period.
* 20. Evidence of current chronic alcohol or drug abuse.
* 21. Current enrollment in an investigational drug or device study or participation in such a study within 4 weeks of the screening visit.
* 22. In the investigator's opinion, evidence of unwillingness, or inability to follow the restrictions and requirements of the protocol and complete the study.
* 23. Taking any investigational product within 1 month of first dose of STP705. | 8,445 |
Study Objectives
The purpose of this study is to finalize development of a questionnaire that measures health-related symptoms and concerns for persons diagnosed with, and either treated or monitored for, anal pre-cancer lesions.
Conditions: Anal High-Grade Squamous Intraepithelial Lesions
Intervention / Treatment:
BEHAVIORAL: Assessment of Health-Related Quality
| Inclusion Criteria:
* Consented to the ANCHOR trial as per self-report and by providing a valid referral code on the information sheet provided by the referring site. Both men and women from the ANCHOR trial will be recruited to this study.
* English fluent as we are only validating this measure in English at this time
* At least one month post-treatment for anal HSIL as per self-report, or if the person is in the ANCHOR trial observation arm, then at least one month post- randomization.
* Within two weeks post initial-treatment for anal HSIL on ANCHOR study or within two weeks post-randomization to ANCHOR study as per self-report.
NOTES:
* ANCHOR participants who are randomized to the treatment arm must have completed initial treatment and are within two weeks of initial treatment completion.
* ANCHOR participants who were treated initially with topical treatment are only eligible within two weeks after the last topical treatment application.
* ANCHOR participants who were treated initially with both topical and ablation treatments are eligible within two weeks of completing both treatments.
* ANCHOR participants who are randomized to the active monitoring arm are eligible if they are within two weeks of randomization
Exclusion Criteria:
* Has a scheduled ANCHOR follow-up appointment in the next two weeks as per self report. The purpose of this exclusion criterion is to minimize the impact on a participant's responses to a post-test evaluation the potential occurrence of an interim diagnosis or treatment event, or anxiety related to an upcoming medical follow-up. | 25,468 |
Study Objectives
This study plans to learn more about a drug called bexarotene for the treatment of advanced thyroid cancer. Subjects are asked to be in this study because they have thyroid cancer that will not respond to radioactive iodine therapy and shows signs of aggressive behavior.
Bexarotene has been FDA approved for the treatment of a type of skin cancer called cutaneous T-cell lymphoma, but has not been FDA approved for this use. Bexarotene is investigational in the treatment of thyroid cancer.
The purpose of this research study is to test how well the study drug works in humans. The study doctors want to know if:
1. The subjects thyroid cancer gets smaller while you are taking the study drug.
2. The subjects thyroid cancer takes up radioactive iodine better after treatment with the study drug than before treatment.
Conditions: Thyroid Cancer
Intervention / Treatment:
DRUG: Bexarotene
| Inclusion Criteria:
* Subject must have a histologically/cytologically confirmed diagnosis of papillary, follicular, or anaplastic thyroid cancer (any follicular cell derived thyroid cancer).
* Subjects must have evidence of follicular cell-derived thyroid cancer progression. In patients with anatomically stable disease, PET positive lesions will also be eligible given the poor prognostic risk for PET positive thyroid cancer.
* Subjects must not be eligible for surgical resection.
* Subjects must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
* Subjects must have laboratory values that fall within certain ranges.
* Subjects must be age 18 years or older.
* Subjects must provide written informed consent prior to any study procedures being performed.
* Females of childbearing potential must have a negative pregnancy test prior to enrollment.
* All eligible subjects must be willing to use adequate contraception throughout the duration of the study.
* Subjects must be willing to submit a primary tumor tissue sample for immunohistochemical analysis.
* Subjects have the option of providing one additional test tube of blood taken at baseline, 6 months and 1 year for banking of plasma for potential future studies (no genetic testing will be conducted). The current planned analysis is for the assessment of a potential peripheral marker for rexinoid responsive cancer - leukemia inhibitory factor (LIF)
Exclusion Criteria:
* Subjects with a known history of hyperlipidemia refractory to treatment.
* Subjects with a known history of hypertriglyceridemia refractory to treatment.
* Subjects with leukopenia below the reference range for the University of Colorado Hospital (UCH) laboratory.
* Subjects, who are pregnant, have a desire to become pregnant or are breastfeeding.
* Subjects who are unwilling or unable to comply with study medication administration, or study guidelines, as determined by the investigator.
* Subjects with any prior history of malignancy with the exception of adequately treated basal cell skin cancer, in situ cervical cancer or other cancer for which the subject has been disease free for 3 years or more.
* Subjects without radiographically assessable disease | 28,345 |
Study Objectives
The purpose of this study is to find out the good and bad effects that occur when temsirolimus is added to standard chemotherapy with carboplatin and paclitaxel.
Conditions: Squamous Cell Cancer, Head and Neck Cancer
Intervention / Treatment:
DRUG: Temsirolimus + Weekly Paclitaxel + Carboplatin
| Inclusion Criteria:
* Patients must have microscopically confirmed head and neck squamous cell carcinoma (HNSCC), recurrent and/or metastatic.
* Confirmation of HNSCC may be obtained from the primary site or metastatic disease.
* Patients must be at least 18 years of age.
* Karnofsky Performance status must be ≥ 70%.
* Disease must be measurable by RECIST criteria.
* At least 6 weeks must have elapsed from previous radiation therapy. Patient must have recovered from the acute toxic effects of treatment prior to study enrollment.
* Adequate organ function, as follows:
* Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥ 1.5 X 109/L, platelets ≥ 100 X 109/L, and hemoglobin ≥ 9 g/dL.
* Hepatic: total bilirubin within normal limits (≤ 1.0 mg/dL); alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5 X ULN (upper limit of normal)
* Renal: Serum creatinine ≤ 1.3 mg/dL. Patients with serum creatinine > 1.3 mg/dL may be eligible if creatinine clearance (CrCl) ≥ 45 mL/min based on the standard Cockroft and Gault formula.
* Patients of childbearing potential must have a negative serum pregnancy test within 14 days of treatment. Patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.
* Patients must sign an informed consent document.
Exclusion Criteria:
* Previous exposure to temsirolimus or other mTOR inhibitors
* More than 2 prior cytotoxic regimens in the recurrent/metastatic disease setting
* History of any brain metastases
* Patients who require concomitant medications that are metabolized by hepatic CYP3A4, due to potential drug-drug interaction with temsirolimus
* Patients with known active interstitial pneumonitis
* Active infection or serious underlying medical condition that would impair the patient's ability to receive protocol treatment.
* Women who are pregnant or lactating
* Other active malignancy, other than indolent malignancies which the investigator determines are unlikely to interfere with treatment and safety analysis
* Diagnosis of Nasopharyngeal cancer is excluded.
* Patients with multifocal peripheral sensory alterations or paresthesias (including tingling) interfering with function, per patient report (example: activities of daily living)
* Therapeutic anticoagulation with Coumadin (warfarin)
* Hypertriglyceridemia ≥ grade 2 (CTCAE version 3.0).
* Impaired lung function: O2 saturation 88% or less at rest on room air by Pulse Oximetry. If O2 saturation is ≤ 88% at rest, further pulmonary function tests (PFTs) should be ordered to confirm normal pulmonary function and eligibility. | 12,172 |
Study Objectives
The overarching goal of the project is to improve the process and experience of surrogate decision-making by family caregivers. Since feeling unprepared to make surrogate decisions is a major contributor to caregiver stress, the primary outcome is caregiver self-efficacy --i.e., caregivers' assessment of how well prepared they feel to serve effectively as a surrogate decision-maker. Through follow-on Renewal funding, we are now also qualitatively examining family caregivers' experience with surrogate decision-making.
Conditions: Neoplasms, Heart Failure, Kidney Diseases, Lung Diseases
Intervention / Treatment:
BEHAVIORAL: Making Your Wishes Known, BEHAVIORAL: Standard advance care planning
| Inclusion Criteria:
* 18 years of age or older* Diagnosis of kidney disease (e.g. chronic kidney disease, end stage renal disease ) OR advanced cancer (Stage IV disease or having an estimated survival of <2 years) OR severe heart failure (e.g. New York Heart Assoc. Class III or Class IV) OR severe lung disease (e.g. Stage III or Stage IV COPD by modified GOLD Spirometric Classification, Idiopathic Pulmonary Fibrosis).* Able to read and understand English at an 8th grade level (word 26 on either blue or tan version of the WRAT-3 reading subtest)* Neuro-cognitively able to engage in ACP (Mini Mental State Exam (MMSE) score >23)* No active suicidal ideations (i.e., score of 0 or 1 on item 9 of the BDI-II).
Exclusion Criteria:
* Failure on any of the above inclusion criteria. | 9,162 |
Study Objectives
According to Seoul cancer registry data (2000), cancer became the leading cause of death in Korea, accounting for 23.9% of all deaths and gastric cancer is the most prevalent malignant neoplasm, comprising 20.8% of all cancers. Korea and some part of Asian countries have the highest incidence of gastric cancer in the world. Therefore, gastrectomy became one of the most common cancer operation in Korea. Thanks to early detection and intervention, the mortality of early gastric cancer drops dramatically and is now believed to be one of the most curable diseases among all the cancers. However, after successful operation and the declaration of cure of the stomach cancer, the patients are left without stomach for all his remaining life. If the patients lose most of his stomach tissue, there are several problems, which include loss of reservoir function for food and indigestion. Besides, loss of appetite is of the paramount importance because the stomach is an important endocrine organ controlling the appetite via gut-brain axis and the main axis is through a hormone called ghrelin, the only orexigenic hormone in human.
Because ghrelin is mainly secreted by the fundus and body, operations such as laryngoscopic Roux-en-Y gastric bypass: (LRYGBP), laryngoscopic-adjustable silicone gastric banding (LASGB) virtually abolish the ghrelin expressing cells. Thus loss of appetite is an inevitable consequence. Then what happens of the plasma ghrelin after Billoth surgery (standard gastric cancer operation) which removes antrum and body of the stomach where ghrelin expressing cells are relatively less distributed? Also puzzling is the fact that after surgery some patients start to gain weight while others continue to lose weight and appetite. Are there ghrelin-expressing cell hyperplasia in the patients who start to gain weight?
The gastrectomy operation which is performed at the investigators institute is Billoth I or II operation. The operation virtually eliminate the half of the body and most of the antrum. If fundus is involved also, proximal gastrectomy is the operation of the choice. Most of the patients who have these operations will lose weight during 1-3 months after surgery, thereafter slowly recover. However, the mechanism of the weight recovery has not been elucidated so far.
To elucidate the mechanism of re-gaining body weight and possible ghrelin expressing cell hyperplasia, the investigators designed the prospective study to investigate the stomach tissue as well as plasma ghrelin in the patients who are going to have Billoth surgery. The items to be investigated include plasma for hormones (ghrelin, leptin, insulin, CCK, PYY), stomach tissue for ghrelin, diet evaluation and body weight (body mass index) changes for 7 months after gastrectomy.
The investigators hope that their study will reveal the valuable information on the body weight recovery and appetite issue. So far the issue of the stomach cancer patients was related to survival issue. However, to lead a comfortable life the quality of life is also very important. The investigators approach will hint the way of surgery which will benefit the patients to live a happy life.
Conditions: Gastric Cancer Patients Treated by Subtotal Gastrectomy
Intervention / Treatment:
| Inclusion Criteria:
* patients with informed consent
* gastric cancer patients treated by subtotal gastrectomy (without chemotherapy or radiation therapy) : Actually the differentiation of EGC or AGC depend on the depth of invasion. Therefore if the patients are not cachetic because of metastasis or tumor burden, there is no need toe exclude the AGC patients from the study.
Exclusion Criteria:
* patients with chemotherapy or radiation therapy diabetes mellitus: It has been reported that plasma ghrelin is influenced by the insulin. Thus a history of diabetes exclude the enrollment of the protocol. | 20,305 |
Study Objectives
Patients who may have been infected with EBV (Epstein-Barr Virus) before or after the time of their transplant have a higher risk of developing Lymphoproliferative Disease (LPD) or may already have a form of this disease.
This research study uses Epstein Barr virus (EBV) specific cytotoxic T lymphocytes (CTLs). These cells have been trained to attack and kill (cytotoxic) EB virus infected cells.
We make these cells from the patients blood by first growing an EBV infected B cell line by infecting the blood with an EBV virus called B-95. We then treat these EBV infected B cells with radiation so they cannot grow and use them to stimulate T cells. This stimulation will train the T cells to kill EBV infected cells. We will then test the T cells to make sure they kill the EBV infected cells.
The purpose of this study is to find the largest safe dose of EBV specific CTLs, to learn what the side effects are, and to see whether this therapy might help prevent or cure EBV related cancers in solid organ transplant patients
Conditions: Epstein-Barr Virus Infections, Lymphoproliferative Disorders
Intervention / Treatment:
BIOLOGICAL: Intravenous injection of EBV specific CTLs
| Inclusion Criteria:
* Patients falling into one of the following categories:
* Organ transplant recipients at high risk of developing LPD:
* EBV seronegative recipients
* Organ transplant recipients receiving OKT3 for immunosuppression
* Organ transplant recipients with evidence of LPD
* Organ transplant recipients with EBV DNA level >1,000 copies
* Age <70 yrs old
* Signed informed consent obtained from patient/guardian
* CTLs available
* Performance status; ECOG £ 2
* Creatinine < 3X normal
* Bilirubin < 5X normal
* AST < 5X normal
* Has not received any other investigational cellular therapies within the past 30 days.
Exclusion criteria:
* Patients with a severe intercurrent infection
* Patients with life expectancy of less than 6 weeks
* Patients receiving supplemental oxygen. | 2,764 |
Study Objectives
This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin when given together with paclitaxel in treating patients with metastatic or unresectable solid tumor. Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining 17-N-allylamino-17-demethoxygeldanamycin with paclitaxel may kill more tumor cells
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Intervention / Treatment:
DRUG: tanespimycin, DRUG: paclitaxel, OTHER: laboratory biomarker analysis, OTHER: pharmacological study
| Inclusion Criteria:
* Histologically confirmed solid malignancy
* Metastatic or unresectable disease
* Not amenable to standard curative or palliative therapy
* No known brain metastases
* Performance status - ECOG 0-2
* More than 12 weeks
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* WBC ≥ 3,000/mm\^3
* AST and ALT ≤ 2.5 times upper limit of normal
* Bilirubin normal
* Creatinine normal
* Creatinine clearance ≥ 60 mL/min
* QTc < 450 msec for male patients (470 msec for female patients)
* LVEF > 40% by MUGA
* No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
* No myocardial infarction within the past year
* No New York Heart Association class III or IV congestive heart failure
* No poorly controlled angina
* No history of uncontrolled dysrhythmia or requirement for antiarrhythmic drugs
* No history of congenital long QT syndrome
* No active ischemic heart disease within the past year
* No left bundle branch block
* No other significant cardiac disease
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective double barrier contraception for at least 1 week before, during, and for at least 2 weeks after study participation
* No prior allergy to eggs
* No prior allergic reaction to compounds of similar chemical or biologic composition to 17-AAG or paclitaxel
* No peripheral neuropathy > grade 1
* No concurrent uncontrolled illness
* No active or ongoing infection
* No psychiatric illness or social situation that would preclude study compliance
* No concurrent granulocyte colony-stimulating factors
* Prior paclitaxel allowed
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
* No prior 17-N-allylamino-17-demethoxygeldanamycin (17-AAG)
* More than 4 weeks since prior radiotherapy
* No prior radiotherapy that included the heart in the field (e.g., mantle radiotherapy)
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No concurrent therapeutic-dose warfarin for anticoagulation
* No concurrent medications that may prolong QTc interval
* No other concurrent investigational agents
* No other concurrent anticancer agents or therapies | 26,748 |
Study Objectives
The study will test the efficacy rituximab in addition to glucocorticoids for the treatment of B-CLL in elderly or unfit patients.
Conditions: B-Cell Chronic Lymphocytic Leukemia
Intervention / Treatment:
DRUG: Rituximab, DRUG: Glucocorticoid
| Inclusion Criteria:
* The diagnosis of CD20 positive chronic B lymphocytic leukemia (BCLL) confirmed by biopsy or flow-cytometry.
* Previously treated patients with stage Rai I-IV and progressive disease (according to IWCLL 2008 guidelines).
Active B-CLL is defined by at least one of the following:
At least one of the disease related symptoms:
* Constitutional symptoms:
* Weight loss >10% within the previous 6 months;
* Fatigue (e.g., WHO performance status >=2);
* Fever >=38C >=2 weeks without evidence of infection;
* Night sweats for more than 1 month without evidence of infection.
* Evidence of progressive marrow failure as manifested by development of, or worsening of, anemia and/or thrombocytopenia
* Autoimmune hemolysis and/or thrombocytopenia poorly responsive to corticosteroid therapy.
* Massive (i.e., >=6 cm bellow left costal margin) or progressive or symptomatic splenomegaly.
* Massive lymphadenopathy or conglomerates (i.e., >=10 cm in largest diameter) or progressive or symptomatic lymphadenopathy.
* Progressive lymphocytosis with an increase >50% over a 2-month period or an anticipated doubling time of less than 6 months. In patients with initial blood lymphocyte counts of less than 30x10\^9/L LDT should not be used as a single parameter to define treatment indication. Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for protocol therapy.
* Either of the following:
* 18 years of age or older with impaired performance status (CIRS > 6) and /or
* 65 years of age or older with any performance status.
* Signed informed consent form.
Exclusion Criteria:
* Intolerance to exogenous protein or known severe reaction to the administration of Rituximab.
* Active infection.
* Cancer radiotherapy, biological therapy or chemotherapy within 3 weeks prior to Study Day 1.
* TBC or fungal infection within the past 6 months even if adequately controlled by treatment.
* Severe organ deficiency preventing the participation in the study.
* Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1.
* Active peptic ulcer.
* Inadequately controlled diabetes mellitus.
* Suspected or confirmed B-CLL CNS disease.
* Known to be HIV positive.
* Difficult to control, uncooperative patients.
* Allergic disorders in need of chronic glucocorticoid therapy.
* Other oncological diseases requiring active treatment (except hormonal therapy).
* Pregnancy and breastfeeding.
* Patients of reproductive potential who are not using effective methods of contraception. | 36,479 |
Study Objectives
The purpose of this randomized controlled clinical trial is to investigate the efficacy and safety of methylphenidate in patients with fatigue caused by cancer.
Conditions: Cancer-related Fatigue
Intervention / Treatment:
DRUG: Methylphenidate hydrochloride, DRUG: Placebo
| Inclusion Criteria:
* history of Cancer
* MFI >40
* Karnofsky Index >=70
* outpatient
* patient are able to give informed consent
Exclusion Criteria:
* treatment with psychostimulants in the past two weeks before screening
* active tumor disease
* depression (HADS >10)
* cachexia (BMI <18kg/m2)
* clinically relevant kidney disorders
* clinically relevant liver disorder
* pathological ECG-finding
* high blood pressure
* occlusive arterial disease
* angina pectoris
* cardiac arrhythmias
* CHD
* post heart-attack status
* post stroke status
* known elevated intra-ocular pressure
* known enlarged prostates
* latent and manifest hyperthyreosis
* alcohol, medication or drug dependency in the past six months or manifest drug abuse
* participation in a clinical study within the past 30 days
* participation in this study at an earlier point in time
* simultaneous participation in another clinical trial
* women of child-bearing age without adequate contraception (contraceptives, intrauterine device , no sexual intercourse)
* pregnancy (positive pregnancy test) or lactation period | 36,526 |
Study Objectives
The primary objective of this study is to determine the major objective response rate of OSI-774 in participants with unresectable or metastatic bronchioloalveolar cell variant of non-small cell lung cancer.
This study is a Phase II study. The first study of OSI-774 was done to evaluate what dose should be given to patients with cancer has been completed. The purpose of this research study is to see whether this experimental treatment, called OSI-774, can cause a type of non-small cell lung cancer to stop growing or shrink. This study is sponsored by a company called Genentech, and is being done at Memorial Hospital, as well as other cancer centers around the country interested in developing new drugs for the treatment of this type of cancer.
Conditions: Bronchioloalveolar Cell Variant of Non-small Cell Lung Cancer
Intervention / Treatment:
DRUG: OSI-774: erlotinib, TarcevaTM
| Inclusion Criteria:
* Either bronchioloalveolar cell carcinoma or a variant thereof after review
* Clinical stage IIIB (malignant pleural or pericardial effusion) or IV or recurrent/medically inoperable disease
* Measurable or evaluable indicator lesions
* No prior or one chemotherapy regimen for NSCLC
* Three weeks since last chemotherapy, and three weeks since prior radiation therapy to a major bone-marrow containing area
* Karnofsky performance status > or = to 80% OR ECOG performance status ≤ or = to 1
* Life expectancy > or = to 8 weeks
* Adequate hematologic, renal and/or hepatic function: WBC > or = to 3,000/ul, hemoglobin > or = to 9.0 g/dl, platelet count > or = to 100,000/ul, total bilirubin < or = to 1.0 mg/dl, AST < than or = to 2.5 X UNL, creatinine < or = to 1.5 mg/dl or Clcr > or = to 55ml/min.
* Effective contraception
Exclusion Criteria:
* Prior exposure to OSI-774 or other treatments targeting the HER family axis (e.g.-trastuzumab, ZD1839, C225, etc.)
* Two or more prior chemotherapy regimens
* Concurrent active cancer
* Uncontrolled central nervous system metastases (i.e. any known CNS lesion which is radiographically unstable, symptomatic and/or requiring escalating doses of corticosteroids)
* Pregnant or lactating women
* Malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
* Prior systemic cytotoxic chemotherapy for other malignant disease
* Significant medical history or unstable medical condition (unstable systemic disease: congestive heart failure, recent MI, unstable angina, active infection, uncontrolled hypertension). | 7,742 |
Study Objectives
Objective: To investigate the potential benefit of adding Thymoquinone to Metformin in alleviating symptoms of polycystic ovarian syndrome.
Methods: 207 overweight and obese PCOS Patients were divided into two groups. Patients in Group A, received Metformin 500 mg three times daily for 6 months. Patients in Group B, received a combination of Metformin 500 mg and Thymoquinone in the form of Black Cumin oil 500 mg capsules three times daily for 6 months. Follow up was done after 3 and 6 months from the beginning of the study for evaluation of menstrual cycle pattern, body mass index, Waist circumference, Hip circumference, and Waist / Hip ratio, Oral glucose tolerance test, Glycosylated Hemoglobin A1C, Superoxide dismutase activity and Malondialdehyde concentration.
Conditions: Polycystic Ovary Syndrome (PCOS)
Intervention / Treatment:
DRUG: Metformin Versus a combination of Metformin and Thymoquinone (TQ)
| Inclusion criteria:
* Age of 18 to 35 years
* Overweight and obese PCOS patients (overweight defined as body mass index (BMI) 25-29.9 kg/m2 and obesity defined as BMI ≥ 30 kg/m2).
* History of amenorrhea or oligomenorrhea with or without hirsutism. Amenorrhea was defined as absence of menstruation for six or more months. Oligomenorrhea was defined as cycle interval of more than 35 days but less than 6 months.
* PCOS diagnosed according to the 2004 Rotterdam ESHRE/ASRM Consensus workshop, with presence of at least 2 out of 3 criteria: oligo- and/or anovulation, clinical and/or biochemical hyperandrogenism, and polycystic ovarian morphology identified by ultrasound with more than 12 small antral follicles in an ovary.
* Prediabetes defined by the American Diabetes Association 2014, as fasting plasma glucose (FPG) levels of 100 to 125 mg/, or impaired glucose tolerance (IGT) defined as 2-hour readings of 140 to 199 mg/dL in the oral glucose tolerance test (OGTT). Also, patients who had their Glycosylated Hemoglobin A1C levels between 5.7% and 6.4%.
Exclusion criteria were:
* Lean or average weight PCOS with BMI < 25 kg/m2, morbidly obese patients with BMI ≥ 35 kg/m2.
* Patients suffering from any other metabolic disorders.
* History of receiving any hormonal treatment or any drug affecting carbohydrate metabolism 3 months prior to the beginning of the study.
* Inability to attend the regular follow up visits.
* Already known and recently diagnosed diabetic patients. According to the American Diabetes Association 2014 (16), diabetes mellitus was defined as Glycosylated Hemoglobin A1C levels ≥ 6.5% or FPG ≥ 126 mg/dL or 2-hour plasma glucose readings ≥ 200 mg/dL during 75 g OGTT, or presence of classic symptoms of hyperglycemia with random plasma glucose levels ≥ 200 mg/dL.
* Thyroid diseases
* Hyperprolactinemia | 12,805 |
Study Objectives
Women with breast cancer and other gynecologic cancers often suffer significant distress and disability from their disease. A practice of meditation-based stress reduction and cognitive-affective-behavioral learning may help women with these conditions decrease their suffering and improve their quality of life.
Conditions: Breast Cancers, Gynecologic Cancer
Intervention / Treatment:
BEHAVIORAL: Mindfulness based meditation program
| Inclusion Criteria:
* All women with stage I-III breast or other gynecologic cancer who have received treatment within the preceding year will be eligible for inclusion in the study.
Exclusion Criteria:
* Patients who refuse to participate will be excluded
* Patients with Metastatic cancer are excluded. | 35,932 |
Study Objectives
This is a multicenter, interventional, randomized study among patients with a first lung or head \& neck cancer who are still active smokers ± alcohol misusers.The study will aim to compare the systematic implementation of an addiction treatment program initiated at hospital and integrated to the initial cancer treatment program (Arm A), versus the as-usual procedure, which consists in recommendations to follow an addiction treatment program (Arm B)
Conditions: Upper Aerodigestive Tract Neoplasms, Lung Cancer
Intervention / Treatment:
PROCEDURE: integrated addiction treatment program, PROCEDURE: standard of care
| Inclusion Criteria:
* Patients with a first upper aerodigestive tract cancer or a lung cancer
* Initial cancer treatment
* Aged ≥ 18 and ≤65 years
* Living within a radius of 20 km from the CHRU de Lille/Oscar Lambret Center
* Patient with tobacco addiction: regular smoker = at least 7 cigarettes /week or 1 cigarette/day or short-term ex-smoker = regular smoker who has stopped smoking for less than 1 year from the inclusion date
* Performance status (ECOG/WHO) ≤ 2
* Registered with a social security system
* Informed and signed consent collected before initiation of any study procedures
Exclusion Criteria:
* Previous lung cancer or upper aerodigestive tract cancer
* Previous other cancer < 5 years, evoluting or treated at the inclusion (except uterine cervical carcinoma, basal cell or squamous cell skin carcinoma )
* Mesothelioma and esophageal cancer
* Occasional smoker (less than 7 cigarettes/week or less than 1 cigarette/day)
* Long-term ex-smokers who have stopped smoking for more than 1 year from the inclusion date
* Impossibility to comply with the study procedures due to geographic, social or mental reasons
* Patient under guardianship or tutorship
* Pregnant or breastfeeding women | 16,931 |
Study Objectives
Background: Achievement of colonoscopy outcomes depends on high-quality bowel preparation by patients; yet inadequate preparation is common.
Objective: To develop and test an educational booklet to improve bowel preparation quality.
Design: "Before-and-after" study followed by randomized controlled trial.
Setting: Veteran Affairs medical center.
Patients: Patients undergoing outpatient colonoscopy
Measurements: The investigators first performed cognitive interviews to identify knowledge and belief barriers to high-quality colonoscopy preparation. The investigators then created a patient educational booklet addressing patient barriers to improve preparatory behaviors. The investigators tested the booklet in 2 sequential studies: (1) controlled "before-and-after" study in patients undergoing colonoscopy during 2 consecutive months: 1 without and 1 with the booklet; (2) randomized controlled trial. The outcome in both studies was bowel preparation quality measured on a 6-point Likert scale (\>5="good"). In each study the investigators compared the proportion achieving a "good" preparation between groups and performed logistic regression to measure the effect of the booklet on preparation quality while adjusting for the purgative received.
Limitations: Unknown impact on polyp yield and cancer reduction.
Conditions: Colon Cancer, Colonoscopy
Intervention / Treatment:
OTHER: Receiving an educational booklet
| Inclusion Criteria:
* Any patient scheduled to undergo outpatient colonoscopic CRC screening or surveillance in VAGLA
Exclusion Criteria:
* In patient admissions | 37,522 |
Study Objectives
The purpose of this study is to determine the maximum tolerated dose (MTD) of pomalidomide in combination with bortezomib and low-dose dexamethasone in subjects with relapsed or refractory multiple myeloma
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: Pomalidomide, DRUG: Bortezomib, DRUG: Dexamethasone
| Inclusion criteria:
* Must be ≥ 18 years at the time of signing the informed consent form.* Subjects must have documented diagnosis of multiple myeloma and have measurable disease (serum M-protein ≥ 0.5 g/dL or urine M-protein ≥ 200 mg/24 hours).* Subjects must have had at least 1 but no greater than 4 prior anti-myeloma therapies.* Subjects must have received at least 2 consecutive cycles of prior treatment with lenalidomide and must be refractory to their last lenalidomide-containing regimen (either as a single agent or in combination).* Subjects must have received at least 2 consecutive cycles of prior treatment with a proteasome inhibitor-containing regimen, but must not be refractory to bortezomib (either as a single agent or in combination).* Subjects must have documented progression during or after their last anti-myeloma therapy.* Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
Exclusion criteria:
* Subjects who are refractory to bortezomib either as single agent or in combination.* Subjects with peripheral neuropathy ≥ Grade 2* Subjects with non-secretory multiple myeloma* Subjects with any of the following laboratory abnormalities:
* Absolute neutrophil count (ANC) < 1,000/µL
* Platelet count < 75,000/µL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; or a platelet count < 30,000/ µL for subjects in whom ≥ 50% of bone marrow nucleated cells are plasma cells
* Creatinine Clearance < 45 mL/min according to Cockcroft-Gault formula
* Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L)
* Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior RBC transfusion or recombinant human erythropoietin use is permitted)
* Serum glutamic oxaloacetic transaminase (SGOT)/ aspartate aminotransferase (AST) or Transaminase, serum glutamic pyruvic (SGPT)/ alanine aminotransferase (ALT) > 3.0 x upper limit of normal (ULN)
* Serum total bilirubin > 1.5 x ULN* Subjects with prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years. Except the following: Basal cell carcinoma of the skin, Squamous cell carcinoma of the skin, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histologic finding of prostate cancer (T1a or T1b using the TNM \[tumor, nodes, metastasis\] clinical staging system) or prostate cancer that is curative.* Subjects with previous therapy with Pomalidomide* Subjects with hypersensitivity to thalidomide, lenalidomide, bortezomib, boron, mannitol, or dexamethasone* Subjects with ≥ Grade 3 rash during prior thalidomide or lenalidomide therapy* Subjects who had any of the following within the last 14 days of initiation of study treatment: Plasmapheresis, Major surgery (kyphoplasty is not considered major surgery), Radiation therapy, Any anti-myeloma drug therapy* Subjects who have received any investigational agents within 28 days or 5 half-lives (whichever is longer) of treatment* Pregnant or breastfeeding females* Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception.* Subjects with known Human immunodeficiency virus (HIV) positivity or active infectious hepatitis A, B, or C | 29,587 |
Study Objectives
To compare the outcomes of fast track laparoscopic surgery and conventional laparoscopic surgery.
Conditions: Colorectal Cancer
Intervention / Treatment:
PROCEDURE: fast-track surgery, OTHER: conventional postoperative surgery
| Inclusion Criteria:
* Age ≤75 years
* Good nutrition
* no systemic infection
* Elective laparoscopic surgery
Exclusion Criteria:
* Age >75 years
* Malnutrition or an organ system infection
* Associated with obstruction, bleeding, emergency surgery or surgical intervention
* Tumor with extensive metastasis
* Before operation patient was fasting, underwent gastrointestinal decompression and received nutritional support
* Previous history of abdominal surgery
* Patient had previously undergone gastrostomy | 6,156 |
Study Objectives
The primary purpose of this trial is to compare the efficacy and safety of DS-8201a and physician's choice treatment in HER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens including fluoropyrimidine agent, platinum agent, and trastuzumab.
Conditions: Neoplasm, Gastrointestinal
Intervention / Treatment:
DRUG: DS-8201a, DRUG: Physician's Choice
| Inclusion Criteria:
* Has a pathologically documented locally advanced or metastatic adenocarcinoma of gastric or gastroesophageal junction* Progression on and after at least 2 prior regimens* Has an adequate tumor sample* Has measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
Exclusion Criteria:
* Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia* Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females* Has a medical history of clinically significant lung disease* Is suspected to have certain other protocol-defined diseases based on imaging at screening period* Has history of any disease, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:
1. safety or well-being of the participant or offspring
2. safety of study staff
3. analysis of results | 5,711 |
Study Objectives
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: This phase II trial is studying how well giving cyclophosphamide and fludarabine together with high-dose interleukin-2 works in treating patients with metastatic melanoma.
Conditions: Melanoma (Skin)
Intervention / Treatment:
BIOLOGICAL: aldesleukin, BIOLOGICAL: sargramostim, DRUG: cyclophosphamide, DRUG: fludarabine phosphate
| Inclusion Criteria:
* Histologically confirmed melanoma
* Metastatic disease
* Measurable disease
* No history of brain metastases
* Over 18
* Karnofsky 60-100%
* Life expectancy At least 12 weeks
* Hematopoietic
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 75,000/mm\^3
* Hemoglobin ≥ 8.5 g/dL
* aspartate aminotransferase ≤ 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
* Bilirubin ≤ 2 times ULN (except for patients with Gilbert's syndrome)
* Hepatitis B and C negative
* Creatinine ≤ 2.0 times ULN
* Creatinine clearance ≥ 50 mL/min
* Cardiovascular
* Ejection fraction ≥ 50%
* No evidence of congestive heart failure
* No symptoms of coronary artery disease
* No serious cardiac arrhythmias
* No myocardial infarction within the past 6 months
* Cardiac stress test negative or of low probability for patients > 40 years of age OR who have had prior myocardial infarction > 6 months ago
* Pulmonary Forced expiratory volume 1 ≥ 2.0 liters OR at least 75% of predicted for height and age
* Diffusing capacity of lung for carbon monoxide ≥ 60%
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
Exclusion Criteria:
* No uncontrolled diabetes
* No history of autoimmune disease
* No active infection
* No other concurrent significant illness that would preclude study participation
* No other malignancy within the past 5 years except nonmelanoma skin cancer or non-invasive cancer (e.g., carcinoma in situ of the cervix, superficial bladder cancer without local recurrence, or carcinoma in situ of the breast)
* At least 4 weeks since prior immunotherapy and recovered
* No other concurrent anticancer biologic agents
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
* No concurrent chemotherapy
* At least 4 weeks since prior steroid therapy
* No concurrent corticosteroids
* At least 4 weeks since prior radiotherapy and recovered
* No concurrent radiotherapy
* At least 4 weeks since prior surgery and recovered
* No concurrent immunosuppressive therapy | 10,696 |
Study Objectives
In this study the investigators are conducting research to determine whether a new optical device using polarization reflectance spectroscopy can help doctors or dentists identify abnormalities in the mouth that require follow-up. To establish this, measurements are needed from a large number of individuals with different abnormalities in their mouth.
The investigators believe the proposed approach has potential to improve and enable mass screening for precancerous and early cancers of the oral cavity by improving the predictive value of oral cavity exams, particularly for less experienced practitioners.
The information from this study will be compared to results from the pathology report of the tissue taken from your mouth.
Hypothesis:
1. Polarized reflectance spectroscopy can distinguish high-risk oral lesion from normal and reactive oral lesions.
2. Polarized reflectance spectroscopy can capture low-grade oral lesions that have characteristics associated with a high risk of progression to cancer.
Conditions: Oral Cancer
Intervention / Treatment:
DEVICE: Polarized Reflectance Spectroscopy System
| Inclusion Criteria:
* You attend the Dental Department at the British Columbia Cancer Agency
* You have an abnormal lesion in the mouth
* You fully understand the study and give your informed consent to participate as demonstrated by signing this consent form
Exclusion Criteria:
* You are under the age of 18 years. | 36,054 |
Study Objectives
This randomized phase II trial studies how well temsirolimus with or without megestrol acetate and tamoxifen citrate works in treating patients with endometrial cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment, has returned after a period of improvement, or is persistent. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of endometrial cancer cells. Hormone therapy using megestrol acetate and tamoxifen citrate may fight endometrial cancer by blocking the use of estrogen by the tumor cells. It is not yet known whether temsirolimus is more effective when given alone or together with megestrol acetate and tamoxifen citrate in treating endometrial cancer.
Conditions: Endometrial Carcinoma, Recurrent Uterine Corpus Carcinoma, Stage IIIA Uterine Corpus Cancer, Stage IIIB Uterine Corpus Cancer, Stage IIIC1 Uterine Corpus Cancer, Stage IIIC2 Uterine Corpus Cancer, Stage IVA Uterine Corpus Cancer, Stage IVB Uterine Corpus Cancer
Intervention / Treatment:
OTHER: Laboratory Biomarker Analysis, DRUG: Megestrol Acetate, DRUG: Tamoxifen Citrate, DRUG: Temsirolimus
| Inclusion Criteria:
* Patients must have histologically confirmed advanced (International Federation of Gynecologists and Obstetricians \[FIGO\] stage III or IV), persistent, or recurrent endometrial carcinoma, which is not likely to be curable by surgery or radiotherapy; histologic documentation of the recurrence is not required
* All patients must have measurable disease; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or >= 10 mm when measured by spiral CT
* Patients must have at least one "target lesion" to be used to assess response, as defined by Response Evaluation Criteria In Solid Tumors (RECIST); tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented
* Prior chemoradiotherapy for a pelvic recurrence is permitted; prior chemotherapy in the adjuvant setting for stage I, II, or III disease is permitted
* Note: no prior chemotherapy in the setting of stage IV disease is permitted unless the patient was without evidence of disease at the completion of chemotherapy and had at least six months of progression-free survival since the completion of chemotherapy
* Regardless of circumstances, no more than one prior chemotherapy regimen (including chemoradiotherapy) is permitted
* Patient must be able to take p.o. medications
* Performance status must be 0-2
* Absolute neutrophil count >= 1,500/mcL
* Platelets >= 100,000/mcL
* Total bilirubin within normal institutional limits
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =< 2.5 times institutional upper limit of normal v 3.0 (=< 5 times upper limit of normal \[ULN\] for subjects with liver metastases)
* Alkaline phosphatase =< 2.5 times institutional upper limit of normal v 3.0 (=< 5 times ULN for subjects with liver metastases)
* Creatinine =< 1.5 times normal institutional upper limit of normal
* Cholesterol =< 350 mg/dL (fasting)
* Triglycerides =< 400 mg/dL (fasting)
* Albumin >= 3.0 mg/dL
* At least 4 weeks must have elapsed since the patient underwent any major surgery (e.g., major: hysterectomy, resection of a lung nodule-minor: a Port-A-Cath placement)
* Patients who have met the pre-entry requirements
* Patients must have signed an approved informed consent including Health Insurance Portability and Accountability Act (HIPAA) authorization
Exclusion Criteria:
* Patients with Gynecologic Oncology Group (GOG) performance status of 3 or 4
* Patients cannot be receiving enzyme-inducing antiepileptic drugs (EIAEDs; e.g., phenytoin, carbamazepine, phenobarbital) nor any other cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducer such as rifampin or St. John's wort, as these may decrease temsirolimus levels; use of agents that potently inhibit CYP3A (and hence may raise temsirolimus levels), such as ketoconazole, is discouraged, but not specifically prohibited; the appropriateness of use of such agents is left to physician discretion
* All concomitant medications must be recorded at baseline
* Patients on maintenance corticosteroids are ineligible with the exception of short term use (fewer than 5 days)
* Patients known to have congestive heart failure; patients with baseline requirement for oxygen; patients with serious concomitant illness that, in the opinion of the treating physician, will place patient at unreasonable risk from therapy on this protocol
* Patients with a history of unprovoked deep vein thrombosis (DVT) or pulmonary embolism (PE), unless patient is maintained on anticoagulation for the duration of the trial; while the exact definition of "provoked" is left to the treating physician, a DVT in the setting of pelvic surgery or trauma would be considered "provoked"
* Women of child-bearing potential must have a negative pregnancy test prior to treatment on study; breastfeeding should be discontinued if the mother is treated with temsirolimus
* Women of child-bearing potential and men must agree to use adequate contraception (barrier method of birth control or abstinence; oral contraceptives \[also known as "the pill"\] are not acceptable) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
* Patients with a concomitant invasive malignancy or a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the past five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
* Patients who have received hormonal therapy or biologic therapy as treatment for endometrial carcinoma
* Patients who have received chemotherapy directed at metastatic or recurrent endometrial carcinoma | 15,308 |
Study Objectives
A phase 1 dose-escalation trial to assess the safety, tolerability, and pharmacodynamics of PF-04691502 in adult cancer patients with solid tumors.
Conditions: Cancer
Intervention / Treatment:
DRUG: PF-04691502
| Inclusion Criteria:
* Patients with a histologically or cytologically confirmed malignant solid tumor for which there is no currently approved treatment or which is unresponsive to currently approved therapies.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
* Female patients of childbearing potential must have a negative serum or urine pregnancy test within 72 hours of the first dose of PF-04961502, These patients or their partners must be surgically sterile or be postmenopausal, or must agree to use effective contraception while receiving trial treatment and for at least 3 months thereafter. Male patients or their partners must be surgically sterile or must agree to use effective contraception while receiving trial treatment and for at least 3 months thereafter. The definition of effective contraception will be based on the judgment of the Principal Investigator or a designated associate
* Adequate Bone Marrow Function, including:
1. Absolute neutrophil count (ANC) ≥1500 cells/mm3
2. Platelets ≥75,000 cells/mm3
3. Hemoglobin ≥9 mg/dL
* Adequate Renal Function, including:
SrCr <1.5 x ULN (upper limit of normal). OR Estimated creatinine clearance ≥60 mL/min, as calculated using method standard for the institution
* Adequate Liver Function, including:
Bilirubin ≤1.5 x ULN AST (SGOT) ≤2.5 x ULN ALT (SGPT) ≤2.5 x ULN
* Adequate glucose control, including no previous diagnosis of diabetes mellitus and HbA1c <7%.
* Adequate Cardiac Function, including:
12-Lead electrocardiogram (ECG) with normal tracing or non clinically significant changes that do not require medical intervention. QTc interval ≤470 msec and no history of Torsades des Pointes or other symptomatic QTc abnormality
Exclusion Criteria:
* Patients with known active brain metastases. Patients with previously diagnosed brain metastases are eligible if they have completed their CNS treatment and have recovered from the acute effects of radiation therapy or surgery prior to the start of study medication, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stable
* Chemotherapy, radiotherapy (other than palliative radiotherapy to lesions that will not be followed for tumor assessment on this study, ie, non target lesions), biological or investigational agents within 2 weeks of Baseline disease assessments
* Any surgery (not including minor procedures such as lymph node biopsy) within 4 weeks of Baseline disease assessments; or not fully recovered from any side effects of previous procedures
* Prior therapy with an agent that is known or proposed to be active by action on PI3K and/or mTOR
* Prior high-dose chemotherapy requiring hematopoetic stem cell transplantation within 12 months of study treatment start
* Uncontrolled or significant cardiovascular disease:
A myocardial infarction within 12 months Uncontrolled angina within 6 months Congestive heart failure within 6 months. Diagnosed or suspected congenital long QT syndrome. Any history of ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes). Any history of second or third degree heart block (may be eligible if currently have a pacemaker) Heart rate <50/minute on pre-entry electrocardiogram Uncontrolled hypertension.
* Current use or anticipated need for food or drugs that are known potent CYP3A4 inhibitors or inducers
* Current use or anticipated need for food or drugs that are known potent CYP1A2 inhibitors or inducers
* Concurrent administration of herbal preparations
* Breast feeding: No studies have been conducted in humans to assess the impact of PF-04691502 on milk production, its presence in breast milk and its effects on the breast-fed child. Because drugs are commonly excreted in human milk and because of the potential for serious adverse reactions in nursing infants, lactating female patients are excluded from this study.
* Any clinically significant gastrointestinal abnormalities, which may impair intake, transit or absorption of the study drug, such as the inability to take oral medication in tablet form and malabsorption syndrome.
* Any mental disorder that would limit the understanding or rendering of informed consent and/or compromise compliance with the requirements of this protocol | 10,665 |
Study Objectives
This study is designed to evaluate the safety, pharmacokinetics and preliminary efficacy of the anti-CD20 monoclonal antibody LFB-R603 in patients with relapsed or refractory B-cell chronic lymphocytic leukemia who have received at least one prior fludarabine-containing regimen.
Conditions: Chronic Lymphocytic Leukemia
Intervention / Treatment:
DRUG: LFB-R603
| Inclusion Criteria:
* Signed informed consent
* Relapsed or refractory B-CLL after at least one prior course of therapy with fludarabine
* Circulating lymphocytes expressing CD20
* Peripheral blood lymphocyte count > 5,000/µL
* ECOG performance status ≤ 2
* Life expectancy ≥ 3 months
* Negative blood pregnancy test before inclusion for women of childbearing potential
* Medically acceptable method of birth control throughout the study for women of childbearing potential
* Being considered as reliable and capable of adhering to the protocol and compliant with study procedures
* Covered by healthcare insurance
Exclusion Criteria:
* Transformation of CLL into a high grade lymphoma
* Allogeneic stem cell transplantation < 6 months before enrolment
* Prior treatment with anti-CD20 monoclonal antibodies < 6 months before enrolment
* Prior treatment with alemtuzumab < 2 months before enrolment
* Treatment with any IMP or participation in a clinical study within 30 days prior to enrolment
* Known severe anaphylactic or other hypersensitivity reactions secondary to a prior exposure to murine antibodies or to any component of LFB-R603
* Patient with prior treatment or concomitant medication that may interfere with the interpretation of the study data
* Patient with a concomitant malignancy other than basal cell carcinoma of the skin, or in situ carcinoma of the cervix or the breast
* Patient with serious non-malignant disease, active infection requiring systemic antibiotic, antifungal or antiviral drug or physical examination or laboratory abnormalities, that would compromise protocol objectives
* Positive serology to HIV, HCV or presence of HBs Ag
* Creatinine clearance, calculated according to Cockroft -Gault formula < 60 mL/min
* ALT and /or AST level > 1.5 times the upper limit of normal
* Pregnancy or breastfeeding | 36,477 |
Study Objectives
Concomitant chemoradiotherapy improves overall survival in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) compared to radiotherapy alone. Cisplatin 100 mg/m2 at day 1, 22 and 43 is widely used but results in considerable acute and late toxicity. Three cycles of carboplatin plus 5-fluorouracil (5-FU) is an accepted alternative but both chemotherapy regimens have not been compared prospectively. The aim of this study is to compare tolerability, efficacy, toxicity and quality of life in patients with LA-HNSCC treated with concomitant cisplatin and carboplatin plus 5-FU.
Conditions: Head and Neck Squamous Cell Carcinoma
Intervention / Treatment:
DRUG: cisplatin, DRUG: carboplatin, DRUG: 5-FU
| Inclusion Criteria:
* Stage III-IV LA-HNSCC of hypopharynx, oropharynx, larynx, oral cavity
* Primary treatment with concomitant chemoradiotherapy consisting of three-weekly cisplatin or carboplatin plus 5-FU
* Age ≤ 70 years
* No previous treatment for head and neck cancer
* No distant metastases
Exclusion Criteria:
* Previous treatment for head and neck cancer
* Distant metastases | 736 |
Study Objectives
The purpose of this study is to assess the safety and tolerability of foretinib (also known as GSK1363089) when used in the treatment of patients with advanced hepatocellular carcinoma (liver cancer).
Conditions: Carcinoma, Hepatocellular
Intervention / Treatment:
DRUG: Foretinib
| Inclusion Criteria:
* Signed informed consent
* 18 years or older
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Has histologically or cytologically confirmed advanced (unresectable and/or metastatic) hepatocellular carcinoma (HCC).
* Has adequate organ system function
* Has at least 1 target tumor lesion.
* Has the ability to swallow and retain oral medication
* Has a life expectancy of at least 12 weeks
* If male:
Agrees to use double-barrier contraception, OR Agrees to complete abstinence from sexual intercourse for 14 days before exposure to investigational product, during the clinical trial, and for at least 21 days after the last dose of investigational product
* If female: Is of nonchildbearing potential OR Is of childbearing potential and has a negative serum pregnancy test within 14 days before the first dose of study drug, and agrees to use adequate contraception.
Exclusion Criteria:
* Has previously used an investigational agent or licensed drug that inhibits multiple receptor tyrosine kinases
* Is currently receiving cancer therapy
* Is currently receiving treatment with an investigational agent, including an investigational anticancer agent
* Has a Child-Pugh score >6
* Has AEs due to investigational drugs or other medications administered more than 21 days before enrollment that have not recovered to Grade 1 or less with the exception of alopecia greater than Grade 1
* Has received local therapy within the following timeframes and the subject has not fully recovered from the prior therapy: Radiotherapy: less than 28 days since completion of prior radiotherapy Chemoembolization, hepatic arterial embolization, percutaneous ethanol injection, or cryoablation: less than 42 days since completion of prior therapy Radiofrequency ablation: less than 60 days since completion of prior therapy Surgery: (1) prior surgical procedure affecting absorption, and (2) less than 28 days since last prior major surgery
* Has a history or clinical evidence of central nervous system metastases or leptomeningeal carcinomatosis
* Has a history of malabsorption syndrome, any medical condition significantly affecting gastrointestinal function, or resection of the stomach or small bowel
* Has active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation, or history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
* Has a known immediate or delayed hypersensitivity or idiosyncratic reaction to drugs chemically related to foretinib.
* Has a QTcB (Bazett-corrected QT interval) or QTcF (Frederica-corrected QT interval) greater than or equal to 470 msec (or 500 msec if the subject has bundle branch block).
* Has a history of any one of the following cardiac conditions or procedures within the past 6 months: Cardiac angioplasty or stenting Myocardial infarction Unstable angina
* Has a history of a cerebrovascular accident within the past 6 months
* Has Class III or IV heart failure as defined by the New York Heart Association functional classification system
* Has poorly controlled hypertension (systolic blood pressure of 140 mm Hg or greater or diastolic blood pressure of 90 mm Hg or greater)
* Has a history of untreated deep venous thrombosis within the past 6 months (e.g., calf vein thrombosis)
* Has a history of main portal vein thrombosis
* Has the presence of any nonhealing wound, fracture, or ulcer, or the presence of symptomatic peripheral vascular disease
* Has had previous or concurrent cancer that is distinct in primary site or histology from HCC, except cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (tumor stages Ta, Tis, and T1). Any cancer curatively treated more than 3 years before study entry is permitted.
* Has a history of bleeding varices within the past 30 days
* Has had clinically significant gastrointestinal bleeding within the past 30 days
* Is a pregnant or lactating female | 19,663 |
Study Objectives
Sorafenib is a multikinase inhibitor which is acting on various cellular pathways involved in the genesis of acute myeloid leukemia (AML). Sorafenib is therefore a promising candidate for improvement of chemotherapy results in AML. This clinical trial evaluates the efficacy of sorafenib added to standard chemotherapy for AML in patients between 18 and 60 years of age. Patients are randomised to receive either sorafenib capsules or placebo in addition to their chemotherapy. The placebo and the sorafenib group will be compared regarding event-free survival and other clinical outcomes. An event is either treatment failure or relapse or death. According to the study hypothesis, the sorafenib group will have less events than the placebo group.
Conditions: Acute Myeloid Leukemia (AML)
Intervention / Treatment:
DRUG: sorafenib, DRUG: placebo
| Inclusion criteria:
* Patients with newly diagnosed AML (except APL) according to the FAB and WHO classification, including AML evolving from MDS or other hematologic diseases and AML after previous cytotoxic therapy or radiation (secondary AML)
* Bone marrow aspirate or biopsy must contain ≥ 20% blasts of all nucleated cells or differential blood count must contain ≥ 20% blasts. In AML FAB M6 ≥ 30% of nonerythroid cells in the bone marrow must be leukemic blasts. In AML defined by cytogenetic aberrations, the proportion of blasts may be < 20%.
* Age ≥ 18 and ≤ 60 years
* Informed consent, personally signed and dated to participate in the study
* ECOG performance status of 0-1
* Life expectancy of at least 12 weeks
* Adequate liver and renal function as assessed by laboratory requirements to be conducted within 7 days prior to Screening
Exclusion criteria:
* Patients who are not eligible for standard chemotherapy as per discretion of the treating physician
* Central nervous system manifestation of AML
* Cardiac disease: heart failure NYHA III or IV; unstable coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
* Chronically impaired renal function (creatinine clearance < 30 ml/min) (Cockcroft-Gault formula)
* Patients undergoing renal dialysis
* Chronic pulmonary disease with relevant hypoxia
* Known HIV and/or hepatitis C infection
* Evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy
* Evidence or recent history of CNS disease, including primary or metastatic brain tumors, seizure disorders
* Resting blood pressure (BP) consistently higher than systolic 160 mmHg and/or diastolic 95 mmHg
* Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardize compliance of the protocol
* Patients with major surgery, open biopsy or significant traumatic injury within 4 weeks of start of first dose
* Serious, non-healing wound, ulcer or bone fracture
* Uncontrolled active infection > Grade 2 NCI-CTC version 3.0
* Concurrent malignancies other than AML
* History of organ allograft
* Allergy to study medication or excipients in study medication | 16,534 |
Study Objectives
A prospective randomized clinical study, with cross-sectional comparisons and correlations was conducted from May 2012 to July 2015 with a sample of 231 patients who have undergone hepatectomy or pancreatectomy, randomized into 2 groups. In group A was applied postoperatively the protocol Fast-track, while in group B the conventional postoperative care. Demographic and clinical data were collected. In 170 patients, Neuropeptide Y (NPY), Adrenocorticotropic hormone (ACTH)/Cortisol plasma levels were measured by ELISA method: a) at the day of patient's admission, b) the operation day, c) the 3rd postoperative day or prior to discharge.
Conditions: Hepatic Cancer, Cancer of Pancreas
Intervention / Treatment:
PROCEDURE: fast track protocol
| Inclusion Criteria:
* patients with American Society of Anesthesiologists (ASA) PHYSICAL STATUS CLASSIFICATION SYSTEM I-III
* age 30-82 years,
* with normal level of consciousness and communication
Exclusion Criteria:
* the presence of chronic pain,
* kidney disease, neuropathy,
* systemic as well as chronic treatment with analgesics | 25,529 |
Study Objectives
This study looks at what effects (good and bad) a drug called PXD-101 (belinostat) in combination with the radioactive drug Zevalin (yttrium Y 90 ibritumomab tiuxetan) has on patients with relapsed aggressive (high-risk) non-Hodgkin lymphoma. Studies in the laboratory suggest that drugs such as PXD101 can act upon specific cancer cell processes to cause either death of the cancer cells or prevention of their growth. In human studies with a small number of patients with this lymphoma, PXD-101 has shown the ability to shrink and slow tumor growth. When Zevalin is delivered directly to the tumor, the lymphoma cells are destroyed and this may result in the disappearance of the tumor (remission)
Conditions: Anaplastic Large Cell Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Mantle Cell Lymphoma
Intervention / Treatment:
DRUG: belinostat, BIOLOGICAL: rituximab, RADIATION: yttrium Y 90 ibritumomab tiuxetan
| Inclusion Criteria:
* Biopsy confirmed, CD20 positive diffuse large B-cell lymphoma, primary mediastinal b-cell lymphoma, mantel cell lymphoma, transformed indolent lymphoma, high grade-B-cell lymphoma; AND bone marrow must show =< 20% CD20+ B-cells with >= 15% cellularity within 42 days of study registration
* Any stage disease
* Patients must have been previously treated:
* >= 3rd line if bone marrow transplant (BMT) candidate OR
* >= 2nd line if not BMT candidate OR
* >= 2nd relapse for BMT candidate OR
* >= 1st relapse for non- BMT candidate
* Must have a diagnostic quality CT scan of the chest, abdomen and pelvis OR baseline PET-CT scan performed within 28 days prior to registration
* Must have bidimensionally measurable disease with lesions at least 1.5 cm in one dimension ALL measurable disease must be assessed within 28 days of registration
* To determine prior drug regimens: radiation therapy counts as 1 treatment, BMT including induction counts as one treatment, radioimmunotherapy is not considered a chemotherapy regimen, rituximab alone is not considered a treatment; all prior therapy must have been completed at least 30 days prior to registration; patients should not have taken valproic acid, or any other histone deacetylase inhibitor (eg., vorinostat, romidepsin), for at least 30 days prior to registration; patients must have recovered from any toxicities related to therapies prior to registration
* No clinical evidence of CNS involvement by lymphoma, any lab (eg., LDH or radiographic tests performed to access CNS involvement must be negative and must be performed within 42 days prior to registration
* Unilateral or bilateral bone marrow biopsy performed within 42 days prior to registration
* Life expectancy of greater than 3 months
* Karnofsky performance status >= 60%
* Leukocytes >= 3,000/mcL
* Absolute neutrophil count >= 1,500/mcL
* Platelets >= 100,000/mcL
* AST (SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal
* Total bilirubin =< 1.5 X institutional upper limit of normal (unless associated with Gilbert's syndrome)
* Serum creatinine < 2 x institutional upper limit of normal OR
* Measured creatinine clearance >= 60 mL/min
* LDH < 1.50 X institutional upper limit of normal
* EKG with no significant abnormalities within 28 days prior to registration
* Women of child-bearing potential and men must agree to use adequate contraception
Exclusion Criteria:
* Patients who have had chemotherapy or radiotherapy within 30 days (6 weeks for nitrosoureas or mitomycin C) prior to study screening or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
* Prior radioimmunotherapy
* Pregnant or nursing
* Clinical evidence of CNS involvement by lymphoma
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to PXD-101 or Zevalin or other agents used in the study
* Concomitant medication that may cause Torsade de Pointes, i.e. prolongation of the QT interval > 500 msec
* Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, congestive heart failure related to primary cardiac disease, any condition requiring anti-arrhythmic therapy, ischemic or valvular heart disease, or a myocardial infarction within the past 6 months
* Current long QT syndrome or baseline prolongation of QT/QTcF interval, i.e. demonstration of a QTcF interval > 450 msec
* Clinical evidence of severe peripheral vascular disease, diabetic ulcers or venous stasis ulcers, or history of deep venous or arterial thrombosis within 3 months prior to screening
* Known to be human immunodeficiency virus (HIV) positive or with known acquired immunodeficiency syndrome (AIDS) syndrome
* Patients may not be receiving any other investigational agents | 17,340 |
Study Objectives
Lung cancer is the leading cause of cancer death worldwide and in the United States. The majority of lung cancers are non-small cell lung cancer (NSCLC). The majority of NSCLC cases are advanced at the time of diagnosis. Chemotherapy has improved overall survival but remains limited at \< 12 months median overall survival. New approaches are needed for second line chemotherapy treatment. Cabazitaxel-XRP6258 has shown increased overall survival in metastatic prostate cancer and it is hopeful it can do the same in advanced NSCLC.
Conditions: Non-small Cell Lung Cancer (NSCLC), Stage IV NSCLC, Metastatic NSCLC
Intervention / Treatment:
DRUG: Cabazitaxel-XRP6258 (3-week cycle), DRUG: Cabazitaxel-XRP6258 (5-week cycle)
| Inclusion Criteria:
* Histologic or cytologic diagnosis of NSCLC (squamous or non-squamous or NSCLC-not specified)
* Subjects who have failed first line chemotherapy (platinum doublets or non- platinum doublets \[previous taxane exposure is allowed\]) for Stage IV NSCLC.
* Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Age > 18 years old
* Adequate bone marrow, liver and renal function, defined as:
* Absolute neutrophil count (ANC) greater than or equal to 1500/ul
* Hemoglobin greater than or equal to 10 g/dl
* Platelet count greater than or equal to 100,000/ul
* Total bilirubin less than or equal to 1.5 x upper limit of normal (except in subjects with documented Gilbert's syndrome)
* AST/ALT less than or equal to 1.5 x upper limit of normal
* Serum creatinine less than or equal to 1.8 mg/dl
* Fully recovered from any previous surgery (at least 4 weeks since major surgery)
* Fully recovered from previous radiation therapy (at least 2 weeks)
* All subjects must agree to practice approved methods of birth control (if applicable). A negative pregnancy test must be documented during the screening period for women of childbearing potential.
* Written informed consent and authorization to use and disclose health information (HIPAA) must be signed by the subject.
* Subjects with symptomatic brain metastases should be adequately treated and controlled prior to the initiation of the study. Subjects with asymptomatic brain metastases will be allowed in the study without any prior therapy for brain metastases.
Exclusion Criteria:
* Concurrent cancer chemotherapy, biologic therapy or radiotherapy
* Administration of any investigational agent within 28 days prior to administration of current therapy
* Untreated symptomatic brain metastases
* Greater than or equal to Grade 2 neuropathy
* Concurrent serious infection
* Concomitant severe or uncontrolled underlying medical disease unrelated to the tumor, which is likely to compromise subject safety and affect the outcome of the study.
* Treatment for a cancer other the NSCLC within 5 years prior to enrollment, with the exception of basal cell carcinoma or carcinoma in situ of the cervix
* Any evidence of history of hypersensitivity for the taxane class of chemotherapy drugs
* History of positive serology for HIV
* Psychiatric disorder that prevents subjects from providing informed consent or following protocol instructions
* Pregnant or lactating women | 30,224 |
Study Objectives
Chemotherapy (CT) is a frequent and well established treatment in women with breast and gynecological tumors. Alopecia is one of the most common side effects of CT seriously impairing patient quality of life and body image. While other CT associated side effects can be controlled by supportive treatment strategy, adequate preventive measures for alopecia have been lacking. New evidence supports the efficacy of scalp cooling for alopecia prevention during CT.
Conditions: Breast Cancer Female, Alopecia
Intervention / Treatment:
DEVICE: Paxman Scalp Cooling System, OTHER: Alopecia Assessments
| Inclusion Criteria:
* Patients with breast or gynecological cancer planning to undergo CT
* CT can be neoadjuvant, adjuvant or palliative
* Up to two lines of CT are allowed. Adjuvant therapy counts as one line
* CT regime is associated with alopecia
* CT must be planned for at least 4 cycles of taxane or anthracyline-based CT regimen
* written informed consent age 18 and older
Exclusion Criteria:
* Migraine
* Cold allergy/Cold Agglutinins/Morbus Raynaud
* Hematological malignancies (Leukemia, non Hodgkins and other generalized lymphomas)
* Manifest scalp metastases
* Overt cognitive impairment
* Insufficient knowledge of German language
Reference Population:
* Patients with breast or gynecological cancer planning to undergo CT
* CT can be adjuvant, neoadjuvant or palliative
* up to two lines of CT are allowed. Adjuvant therapy counts as one line.
* CT regime is associated with alopecia
* CT must be planned for at least 4 cycles of taxane or anthracycline-based CT regime
* Refuse to undergo scalp cooling
* Patients who have been excluded for the study group for the reason of migraine
* written informed consent
* age 18 and older | 34,536 |
Study Objectives
Prostate cancer is currently detected by ultrasound-guided biopsy. Computer-aided diagnostic (CAD) systems based on multiparametric MRI are now capable of detecting most aggressive cancer foci non-invasively, but additional progress is needed for the technique to be accepted in clinical practice. We hypothesize that combining MRI and ultrasound imaging can improve the detection of cancerous tumors. As a first step in this direction, we need to create a database with MR images, 3D ultrasound images, and corresponding histopathology results, in patients treated by radical prostatectomy for prostate cancer. This is the purpose of the present study.
In a later stage (outside the scope of this study), we will be learning how to combine these images to best recognize cancerous tumors, we will use that knowledge to develop a new CAD system, and we will assess the performance of the new CAD. We expect this future system to improve the detection of prostate cancer and to reduce the number of patients requiring biopsy.
Conditions: Prostate Cancer
Intervention / Treatment:
DEVICE: 3D prostate ultrasound
| Inclusion Criteria:
* Patient referred for radical prostatectomy
* Patient with multiparametric prostate MRI (3T) performed in our institution (Edouard Herriot Hospital) in the year preceding the surgery
* Informed consent signed
* Patient affiliated to the French Health Insurance system
Exclusion Criteria:
* History of prostatic surgery or radiation therapy (prostatic or pelvic)
* History of hormone therapy for prostate cancer
* Previous surgery of the abdomino-perineal region, or other contraindication for transrectal ultrasound
* Patient on protection of the court, under supervision or under trusteeship
* Inability to express a consent | 24,868 |
Study Objectives
Because locally far-advanced gastric cancer combined with adjacent tissue invasion has a poor prognosis, some phase 2 and 3 clinical trials of neoadjuvant chemotherapy (NAC) are performed in Japan. However, neoadjuvant chemoradiotherapy (NACRT) achieves superior local tumor control compared with NAC. This feasibility trial explored the feasibility and safety of neoadjuvant chemoradiotherapy (NACRT) in this type of gastric cancer.
Conditions: Gastric Cancer, Chemoradiation
Intervention / Treatment:
| Inclusion Criteria:
* Histologically proven gastric adenocarcinoma
* Tumor invasion of adjacent structures (T4) and/or tumors with bulky nodal metastases
* No metastases outside of Group 2 lymph nodes
* Neither peritoneal metastasis nor liver metastasis
* No other distant metastasis
* An Eastern cooperative oncology group performance status of between 0 and 2
* No prior radiation therapy
* Sufficient organ function
Exclusion Criteria:
* A synchronous or previously active malignancy
* Insufficient oral intake
* A history of severe allergy
* Watery diarrhea
* Severe co-morbidities
* Requiring therapy for pericardial effusion or pleural effusion
* Contraindications to S-1 or radiotherapy. | 25,140 |
Study Objectives
This phase I trial studies the side effects and best dose of dinaciclib and bortezomib when given together with dexamethasone in treating patients with multiple myeloma that has returned after a period of improvement. Dinaciclib and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving dinaciclib and bortezomib together with dexamethasone may kill more cancer cells.
Conditions: Recurrent Plasma Cell Myeloma
Intervention / Treatment:
DRUG: Bortezomib, DRUG: Dexamethasone, DRUG: Dinaciclib, OTHER: Laboratory Biomarker Analysis
| Inclusion Criteria:
* Serum creatinine =< 2.5 mg/dL
* Absolute neutrophil count >= 1000/uL
* Untransfused platelet count >= 75000/uL
* Hemoglobin >= 8 g/dL
* Total bilirubin =< 1.5 times institutional upper limit of normal (ULN)
* Patients with relapsed multiple myeloma who have already received one or more standard treatment regimens
* Measurable disease of multiple myeloma as defined by at least ONE of the following:
* Serum monoclonal protein >= 1 g/dL
* >= 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
* Serum immunoglobulin free light chain >= 10 mg/dL and abnormal serum immunoglobulin kappa to lambda free light chain ratio
* Monoclonal bone marrow plasmacytosis >= 30% (evaluable disease)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
* Adequate residual organ function per treating physician discretion; Note: there is no limit with regard to the number of prior therapies
* Provide informed written consent
* Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
* Willing to provide samples for correlative research purposes
* Willing to return to consenting institution for follow-up during the study
* Recovered (i.e., =< grade 1 toxicity) from the reversible effects of prior antineoplastic therapy
Exclusion Criteria:
* Any of the following recent therapies:
* Alkylators (e.g. melphalan, cyclophosphamide) =< 14 days prior to registration
* Anthracyclines =< 14 days prior to registration
* High dose corticosteroids, immune modulatory drugs (thalidomide or lenalidomide), or proteosome inhibitors (bortezomib) =< 7 days prior to registration
* Concomitant high dose corticosteroids (concurrent use of corticosteroids); EXCEPTION: patients may be on chronic steroids (maximum dose 20 mg/day prednisone equivalent) if they are being given for disorders other than amyloid, i.e., adrenal insufficiency, rheumatoid arthritis, etc.
* Other active malignancy =< 2 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma in-situ of the cervix; NOTE: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer
* Any of the following:
* Pregnant women or women of reproductive ability who are unwilling to use 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of study drug
* Nursing women
* Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 30 days after stopping treatment
* Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
* Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
* Peripheral neuropathy >= grade 2 on clinical examination during the screening period
* Major surgery =< 14 days prior to registration
* Currently taking strong or moderate inhibitors/inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4); Note: dinaciclib is a CYP3A4 substrate; patients should not take grapefruit/grapefruit juice or St. John's wort; use of strong or moderate CYP3A4 inhibitors is prohibited from < 7 days prior to registration; use of CYP3A4 inducers is prohibited from =< 7 days prior to registration
* Any of the following conditions:
* Myocardial infarction =< 6 months prior to registration or has New York Heart Association (NYHA) class III or IV heart failure
* Uncontrolled angina
* Severe uncontrolled ventricular arrhythmias
* Electrocardiographic evidence of acute ischemia
* Active conduction system abnormalities; NOTE: prior to study entry, any electrocardiogram (ECG) abnormality at screening must be documented by the investigator as not medically relevant
* Known hypersensitivity to bortezomib, boron, or mannitol
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study per the judgment of the treating physician | 31,939 |
Study Objectives
The goal of this clinical research study is to find the highest tolerable dose of paclitaxel that can be given as hyperthermic intraperitoneal chemotherapy (HIPEC) to patients with gastric or gastroesophageal cancer. HIPEC is a system in which heated chemotherapy is delivered directly inside the abdomen during surgery. In this study, paclitaxel is being combined with mitomycin and cisplatin to see if this study drug combination can help to control the disease.
This is an investigational study. Mitomycin, cisplatin, and paclitaxel are FDA-approved and commercially available for the treatment of gastric and gastroesophageal cancer. It is investigational to give these drugs by HIPEC.
The study doctor can describe how the study drugs and HIPEC are designed to work.
Up to 48 participants will be enrolled in this study. All will take part at MD Anderson.
Conditions: Diseases of Oesophagus Stomach and Duodenum
Intervention / Treatment:
DRUG: Dexamethasone, DRUG: Diphenhydramine, DRUG: Famotidine, DRUG: Mitomycin C, DRUG: Cisplatin, DRUG: Paclitaxel
| Inclusion Criteria:
* Age 18 years and above. There will be no upper age restriction.* Eastern Cooperative Oncology Group (ECOG) performance status <= 2.* Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction.* Adequate renal, and bone marrow function: a. Leukocytes >= 3,000/uL b. Absolute neutrophil count >= 1,500/uL c. Platelets >= 60,000/Ul d. Serum creatinine <= 1.5 mg/dL* Distant Metastatic Disease of peritoneum: a. Positive peritoneal cytology b. Carcinomatosis on diagnostic laparoscopy or laparotomy.* Completion of preoperative systemic chemotherapy.
Exclusion Criteria:
* Infections such as pneumonia or wound infections that would preclude protocol therapy.* Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence.* Subjects with unstable angina or New York Heart Association Grade II or greater congestive heart failure.* Subjects deemed unable to comply with study and/or follow-up procedures.* Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity. | 35,123 |
Study Objectives
This study evaluates the feasibility of a clinical informatics system-based approach to lung cancer screening. Patients of a large academic medical center who may qualify for lung cancer screening will be sent an electronic invitation to complete an online lung cancer screening decision aid.
Conditions: Lung Neoplasms
Intervention / Treatment:
BEHAVIORAL: Decision Aid Invitation
| Inclusion Criteria:
* Has an active patient portal account
* Scheduled to see a Wake Forest primary care provider within the next 4 weeks
Exclusion Criteria:
* Never smokers
* Current or former history of lung cancer
* Receipt of chest CT scan within last 12 months
* Need for a language interpreter
* Presence of disease predicting short life-expectancy | 22,135 |
Study Objectives
Evaluated the correlation between the qualitative test results of Xiamen Aide PD-L1 antibody reagent (immunohistochemistry) and the efficacy of Keytruda single-agent therapy, and the research data is used to support the registration and marketing of the assessment reagent
Conditions: Non Small Cell Lung Cancer
Intervention / Treatment:
| Inclusion Criteria:
* ≥18,advanced non-small cell lung cancer confirmed by histopathology, and have received K-drug mono-therapy in the past, the return visit information is complete, with traceable information such as tumor imaging examinations before and after treatment, and the curative effect can be judged;* Able to provide FFPE samples with a storage life of 4 years: 6 slices of continuous slices with a thickness of 3-5μm
Exclusion Criteria:
* Pathological evaluation of the tissue sample has too few tumor cells (total number of tumor cells <100);* K-drug mono-therapy is neoadjuvant therapy or adjuvant therapy;* Other situations that the investigator thinks are not suitable for participating in this clinical study | 841 |
Study Objectives
Briefly, this is a 28-day dietary intervention study participants will be asked to eat 2 ounces (52 grams) of walnuts every day for 3 weeks, and at the end of the study period they will come in for a colonoscopy. Participants will first start a 1-week run-in period where they will be asked to avoid foods high in ellagic acid. In addition, they will be asked to complete food surveys and two sets of 3-day dietary records, and to provide colon biopsies for this study during their routine colonoscopy, as well as a blood, and two urine and stool samples. Urine samples will be used for analysis of urolithin, ellagic acid metabolites. Stool samples will be used to assess gut microbiota changes after walnut consumption. Dietary records will be used for compliance and Food Frequency Questionnaire will be used to assess dietary habits. Lastly, the biopsy samples will be used for analysis of biomarkers and anti-inflammatory in the colon, as well as adherent microbiome to the colonic tissue. Data will be analyzed based on the urolithin phenotypes.
Conditions: Colo-rectal Cancer, Colon Cancer, Diet Habit
Intervention / Treatment:
OTHER: Walnuts
| Inclusion Criteria:
* Men or women between the ages of 50-65 years old who are scheduled to undergo a routine screening colonoscopy
* English speaking/reading patients willing and able to provide written informed consent for study participation
* Patients willing to consume walnuts for 3 weeks
* Willingness to comply with all study requirements
Exclusion Criteria:
* Current active malignancy, previous history of gastrointestinal malignancy, or altered gastrointestinal anatomy
* Current evidence or previous history of ulcerative colitis or Crohn's disease
* HIV infection, chronic viral hepatitis
* Allergy to walnuts or hypersensitivity to tree nuts
* Use of antibiotics within the past month
* Individuals with blood coagulation disorders or on anti-coagulant therapy
* Treated with steroids, immunosuppressive agents or other anti-inflammatory drugs one week prior to starting intervention
* Non-English-speaking patients who require an interpreter to give consent
* Patients residing in the Department of Correction
* Inability to comply with the protocol requirements
* Any other condition that, in the opinion of the PI, might interfere with study objectives | 25,707 |
Study Objectives
The hypotheses of this study are:
1. Delivery of single fraction Lattice Extreme Ablative Dose (LEAD) radiotherapy (RT) to the dominant tumor lesion(s) in the prostate as identified by multiparametric functional Magnetic Resonance Imaging is safe and feasible when given prior to standard prostate radiotherapy.
2. Biomarker expression levels differ in the functional MRI identified suspicious tumor regions and unsuspicious tumor regions. The investigators hypothesize that a significant source of variation in biomarker levels is due to tumor heterogeneity and that it is molecular abnormalities in the dominant tumor areas that are angiogenic and determine outcome.
Conditions: Prostate Cancer, Prostate Adenocarcinoma
Intervention / Treatment:
RADIATION: Lattice Extreme Ablative Dose Radiation Therapy, RADIATION: Standard IMRT
| Inclusion Criteria:
* Biopsy confirmed adenocarcinoma of the prostate.* T1-T3a disease based on digital rectal exam (DRE).
* T3a disease based on MRI is acceptable (no evidence of frank (clear cut) seminal vesicle (SV) involvement or invasion of bladder or rectum).* Gleason score 6-10.* Patients with Gleason score ≥8 must be offered long term androgen deprivation therapy (ADT) and refuse such treatment because only 4-6 months (+/- 2 months) (short term ADT) is permitted (not required) on this protocol. The ADT is recommended to begin after fiducial marker placement; however, ADT is permitted to have been started up to two months prior to the signing of consent. All patients in this protocol may (not required) be treated with 4-6 months (+/- 2 months) of ADT, at the discretion of the treating physician.
* Gleason ≥ 8 must have < 40% of the tissue involved with Gleason 8 in the biopsy specimen.* Prostate-specific antigen (PSA) ≤ 30 ng/mL within 3 months of enrollment. If PSA was above 30 and dropped to ≤ 30 with antibiotics, this is acceptable for enrollment.* No previous pelvic radiotherapy.* No previous history of radical/total prostatectomy (suprapubic prostatectomy is acceptable).* No concurrent, active malignancy, other than nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for ≥ 5 years then the patient is eligible.* Identifiable multiparametric-MRI tumor lesion or lesions, that total in volume < 33% of the prostate
* Multiparametric MRI of prostate and pelvis is required prior to protocol consideration.
* If contrast not given, the point dose on the apparent diffusion coefficient (ADC) map should be < 1000.* Ability to understand and the willingness to sign a written informed consent document.* Zubrod performance status < 2.* Willingness to fill out quality of life forms.* Bone scan negative if PSA > 15 ng/mL or Gleason ≥ 8 disease. A questionable bone scan is acceptable if other imaging tests are negative for metastasis.* Serum testosterone is within 40% of normal assay limits (e.g., x=0.4\*lower assay limit and x=.04\*upper assay limit + upper assay limit), and taken within 4 months of enrollment. Patients who have been started on ADT prior to signing consent are not required to have a serum testosterone at this level prior to signing consent; but, a serum testosterone prior to fiducial marker placement is recommended.* Serum liver function tests (LFT) are taken within 3 months of enrollment.* Complete blood counts are taken within 3 months of enrollment.* Age ≥ 35 and ≤ 85 years.
Exclusion Criteria:
* > T3a disease on digital rectal exam or >T3a disease clearly identified by MRI.* Gleason score < 6.* ≥ 40% Gleason 8-10 tumor, over the total tissue including other tumor and normal tissue. For example: (Gleason 8-10 tumor length/other biopsy tissue length)\*100 = ≥ 40%.* Androgen deprivation therapy longer than 8 months. Androgen deprivation timing is for the Luteinizing hormone-releasing hormone (LHRH) agonist portion only and not when anti-androgen is started beforehand with the purpose of counteracting the surge in testosterone from the LHRH agonist - PSA > 30 ng/mL within 3 months of enrollment.* PSA > 30 ng/mL within 3 months of enrollment* Unable to obtain a 1.5T or 3.0T multiparametric MRI of the pelvis and prostate with contrast.* Unidentifiable multiparametric MRI tumor lesion.* Identifiable multiparametric-MRI tumor lesions, that total in volume ≥ 33% of the prostate.* Previous pelvic radiotherapy.* Previous history of radical prostatectomy.* Concurrent, active malignancy, which is not nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for < 5 years then the patient is not eligible.* Zubrod performance status ≥ 2.* Inability to understand or unwilling to sign a written informed consent document* Unwilling to fill out quality of life/psychosocial forms.* Bone scan is positive and other imaging tests confirm a suspicion of metastasis from prostate cancer.* Serum testosterone is not within 40% of normal assay limits taken within 4 months of enrollment (only applicable to patients not started on ADT prior to signing consent).* Serum liver function tests (LFTs) are not taken within 3 months of enrollment.* Complete blood counts are not taken within 3 months of enrollment.* Age < 35 and > 85 years. | 24,068 |
Study Objectives
The standard treatment for women with a relatively small breast cancer without arguments for involvement of the axillary lymph nodes, is breast conserving surgery followed by radiotherapy of the whole breast, often with a complementary dose to the operated area (boost). A delay of 3-4 weeks after surgery is advisable for allowing wound healing before the start of radiotherapy. Historically, whole breast radiotherapy plus boost are delivered in 6-7 weeks. This treatment can be associated with temporary fatigue and decrease in quality of life. Randomized trials have shown that shorter schedules, delivering slightly more dose per day during 3 weeks, are equal to the long schedules. In an earlier clinical study, the investigators have tested such a short schedule and shown that it is equally safe and equally well tolerated as the conventional schemes. Other hospitals have examined (and still are examining) the safety and tolerance of even shorter schedules, delivering radiotherapy in 1 week.
This clinical study involves delivering radiotherapy in 1 week and before the surgery in stead of following surgery. In the postoperative setting, it is often debatable which volume should be included in the boost. Often boost-volumes remain large because of uncertainties in delineation. Preoperative radiotherapy has the advantage that the tumor is visible on imaging. This can result in smaller boost volumes. The surgery will follow shortly after termination of the radiotherapy, resulting in a very short treatment period.
This study is an open study investigating the effect on quality of life of a very short preoperative radiotherapy for early breast cancer.
Conditions: Breast Cancer
Intervention / Treatment:
RADIATION: Tomotherapy
| Inclusion Criteria:
* Age ≥ 18 years
* Histological diagnosis of unifocal invasive breast carcinoma, no special type (ductal carcinoma)
* Tumor Staging: cT1-2N0M0
* Luminal A or B
* Candidate for breast conserving surgery
* N0-status confirmed by lymph node cytology
Exclusion Criteria:
* Multifocal/multicentric disease
* Prior thoracic radiotherapy
* Pregnancy
* SBR3 grading
* Triple negative status which benefit neoadjuvant chemotherapy | 27,275 |
Study Objectives
Preclinical studies at our institution, using a genetic mouse model of gastric cancer, strongly suggest that innervation of the stomach wall is required not only for the development, but also for the progression of gastric cancer, and that denervation of the stomach either by vagotomy or by injection of botulinum toxin (Botox®) in the stomach wall may represent an effective therapeutic intervention. New treatment options for inoperable cancer in the stomach are urgently needed, and local treatment with botulinum toxin seems to be an attractive possibility. In this pilot study Botox injections will be given by gastroscopy in both the tumor and the surrounding stomach wall. The purpose of the study is to obtain data needed to calculate sample size in a larger controlled trial.
Conditions: Stomach Neoplasms
Intervention / Treatment:
DRUG: Botox
| Inclusion criteria:
Patients with verified gastric adenocarcinoma but found non-resectable or inoperable after evaluation in the appropriate multidisciplinary team at St.Olav Hospital. Trondheim University Hospital. The inclusion criteria for such patients are:
* Patients who have received 1.line and 2. line chemotherapy but no longer respond to such therapy.* Patients who, due to toxicity of chemotherapy, cannot be offered such treatment.* Patients who, after meticulous information about chemotherapy, still do not want such treatment.* Patients with performance status (ECOG) 0-2.
Exclusion criteria:
* Known allergy to any of the components in Botox®* Known peripheral motor neuropathy disease ( for example: Amyotrophic Lateral Sclerosis, ALS), or subclinical or clinical deficiency of neuromuscular transmission (for example: Myasthenia Gravis or Eaton-Lambert's Syndrome).* Pregnant or lactating women.* Another cancer disease that is not under control.* Another concomitant treatment for cancer.* Serious mental illness.* Performance status (ECOG) 3-4. | 12,604 |
Study Objectives
The overall aim of the trial is to investigate the safety and anti-tumour activity of an experimental drug BI 836845 taken together with the prostate cancer drug, enzalutamide, compared to enzalutamide given alone, in castrate resistant prostate cancer (CRPC) patients that have previously been treated and failed on docetaxel and abiraterone treatments. Initially, a tolerability and safety phase (phase Ib escalation) will be performed to confirm the maximum tolerated dose (MTD), or recommended doses of both BI 836845 and enzalutamide that can be taken together.
Once the MTD, or recommended phase II dose, have been determined an expansion cohort will also be explored (phase Ib expansion) in CRPC patients already taking enzalutamide and have a rise in prostate serum antigen (PSA) levels. Patients may not have received prior docetaxel or abiraterone. Patients in this cohort will receive the MTD, or recommended phase II dose, of BI 836845 and enzalutamide determined in the phase Ib escalation phase.
The randomised trial (phase II) will be an open label, parallel group study design in a 1:1 ratio to which patients will receive either BI 836845 plus enzalutamide (Arm A) at the MTD/recommended doses, or enzalutamide alone (Arm B).
In all parts of the trial safety, anti-tumour activity will be assessed, in addition to circulating tumour cells (CTC), prostate serum antigen (PSA) response and progression, and determination of Overall Survival (OS).
Conditions: Prostatic Neoplasms, Castration-Resistant
Intervention / Treatment:
DRUG: BI 836845, DRUG: Enzalutamide, DRUG: Enzalutamide
| Inclusion criteria:
* The patient has histologically, or cytologically, confirmed adenocarcinoma of the prostate.
* Male patient aged, equal to, or more than,18 years old.
* Patients with radiographic evidence of metastatic prostate cancer (stage M1 or D2). Distant metastases evaluable by radionuclide bone scan, CT scan, or MRI within 28 days before the start of study treatment.
* Patients with a prostate serum antigen (PSA), equal to, or more than, 5 nanograms per mililiter (ng/mL).
* Patients with prior surgical or chemical castration with a serum testosterone of <50 ng/mL. If the method of castration is luteinizing hormone releasing level hormone (LHRH) agonists, the patient must be willing to continue the use of LHRH agonists during protocol treatment.
* Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
* Cardiac left ventricular function with resting ejection fraction >50% as determined by echocardiogram (ECHO) or multigated acquisition scan (MUGA).
* Absolute neutrophil count (ANC) >=1500/microlitre (uL).
* Haemoglobin >=9 gram per deciliter (g/dL).
* Platelets >=100,000/uL.
* Bilirubin <= 1.5 times the upper limit of normal (ULN).
* Aspartate transaminase (AST) and alanine transaminase (ALT) <= 2.5 times the ULN(or <= 5 times the ULN if liver metastases are present).
* Creatinine <= 1.5 x ULN.
* International normalized ratio (INR) <= 2 and a partial thromboplastin time (PTT) <= 5 seconds above the ULN (unless on oral anticoagulant therapy). Patients receiving full dose anticoagulation therapy are eligible provided they meet all other criteria, are on a stable dose of oral anticoagulant or low molecular weight heparin (except warfarin or coumarin-like anticoagulants, which are not permitted).
* Fasting plasma glucose < 8.9 millimols per liter (mmol/L) (< 160 milligrams per deciliter (mg/dL) and glycated haemoglobin (hemoglobin A1c (HbA1c)) < 8.0%.
Inclusion criteria only for patients entering phase Ib escalation and phase II:
* Patients who have disease progression during, or after, receiving docetaxel and have had at least 12 weeks of treatment and in the opinion of the investigator are unlikely to derive significant benefit from additional docetaxel-based therapy, or were intolerant to therapy with this agent.
* Patients who have disease progression during, or after, receiving abiraterone treatment in any setting.
* Patients must have progressive disease defined as at least one of the following:
1. Progressive measurable disease: using conventional solid tumour criteria RECIST 1.1.
2. Bone scan progression: at least two new lesions on bone scan, plus a rising PSA as described in (c) below.
3. Increasing PSA level: at least two consecutive rising PSA values over a reference value (PSA #1) taken at least 1 week apart. A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2.
Inclusion criterion only for patients entering phase Ib expansion cohort:
* Patients must be receiving continuous enzalutamide treatment and show a rise in PSA level: at least two consecutive rising PSA values over a reference value (PSA #1) taken at least 1 week apart. A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2.
* Archive tumour tissue is available prior to recruitment for pharmacogenomic tests
Exclusion criteria:
* Prior therapy with agents targeting Insulin Growth Factor (IGF) and/or Insulin Growth Factor Receptor (IGFR) pathway.
* Patients that have been treated with any of the following within 4 weeks of starting trial treatment: chemotherapy, immunotherapy, biological therapies, molecular targeted, hormone therapy (except LHRH agonists and LHRH antagonists), radiotherapy (except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture which can then be completed within 2 weeks prior to study treatment).
* Use of any investigational drug within 4 weeks before start of trial treatment or concomitantly with this trial.
* Patients that have been treated with strong cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) inhibitors, CYP2C8 inducers, within 2 weeks of starting the trial treatment.
* Fridericia´s Corrected QT interval (QTcF) prolongation > 450 ms or QT prolongation deemed clinically relevant by the investigator (e.g., congenital long QT syndrome). The QTcF will be calculated as the mean of the 3 ECGs taken at screening.
* Patients with small cell or neuroendocrine tumours.
* Patients with known or suspected leptomeningeal metastases.
* Uncontrolled or poorly controlled hypertension.
* Known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness.
* Patients with epilepsy, seizures, or predisposing factors for seizure as judged by the investigator.
* Patients unable to comply with the protocol as judged by the investigator.
* Active alcohol or active drug abuse as judged by the investigator.
* A history of allergy to human monoclonal antibodies.
* Patients who are sexually active and unwilling to use a medically acceptable method of contraception, e.g. condom plus spermicide use for participating males, plus another form of birth control such as implants, injectables, combined oral contraceptives, intrauterine devices for female partners, during the trial and for at least three months after end of active therapy. Men unwilling to agree to not donate sperm while on trial drug and up to 6 months following the last dose of trial drug.
* Previous or concomitant malignancies at any other site with the exception of the following:
* benign basal cell carcinoma
* benign low grade transitional cell carcinoma of the bladder
* other effectively treated malignancy that has been in remission for more than 5 years and is considered to be cured
* Only for patients entering phase Ib dose escalation and phase II cohorts:
* Patients who have received more than 2 prior non-docetaxel containing cytotoxic chemotherapy regimens for Metastatic Castration-Resistant Prostate Cancer (mCRPC).
* Patients who have received a taxane based treatment or abiraterone, within 4 weeks before start of study treatment.
* Patients that have received prior enzalutamide in any setting will not be eligible.
Exclusion criterion only for patients entering phase Ib expansion cohort:
* Patients that have received prior taxane-based chemotherapy or abiraterone in any setting will not be eligible for the expansion cohort.
Additional exclusion criterion for patients undergoing tumour biopsy:
* For patients that are to undergo the tumour biopsy, a history of a hereditary bleeding disorder, or clinically relevant major bleeding event in the past 6 months, as judged by the investigator.
* Further exclusion criteria apply | 3,918 |
Study Objectives
A minority of patients with adult acute lymphoblastic leukemia (ALL) relapse are rescued. The aim of this population-based study was to assess the results of reinduction treatment and allogeneic stem cell transplantation (SCT) in second complete remission (CR) in Sweden 2003-2007.
Conditions: Acute Lymphoblastic Leukemia
Intervention / Treatment:
| Inclusion Criteria:
* Adult patients with first relapse of ALL
Exclusion Criteria:
* patients with Burkitt leukemia | 26,695 |
Study Objectives
To assess and quantify the changes in bone mineral density between the ARIMIDEX and ARIMIDEX plus NOLVADEX groups when compared to the NOLVADEX alone treatment group whilst receiving trial therapy.
Conditions: Bone Density
Intervention / Treatment:
DRUG: Anastrozole, DRUG: Tamoxifen
| Inclusion Criteria:
* Eligible for entry into the main ATAC trial 1033IL/0029
* Women defined as post-menopausal
* Patients with histologically proven operable invasive breast cancer
* Who following primary surgery have a good prognosis and would be ethically suitable to remain untreated
Exclusion Criteria:
* Excluded from entry into the main ATAC trial (1033IL/0029)
* Patients who have received hormone replacement therapy within the previous 12 months prior to randomisation
* Patients who have received bisphosphonate therapy within the previous 12 months prior to randomisation
* Patients who have had a bone fracture within the previous 6 months prior to randomisation | 4,220 |
Study Objectives
This trial compares the effect of intermittent fasting versus continuous caloric reduction for the reduction of body weight in Black adults of faith. Intermittent fasting and continuous caloric reduction interventions may help Black adults of faith lose weight, improve their health, and help reduce cancer risk.
Conditions: Obesity-Related Malignant Neoplasm
Intervention / Treatment:
BEHAVIORAL: Lifestyle Therapy, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration, OTHER: Short-Term Fasting
| Inclusion Criteria:
* African American/Black
* Body mass index (BMI) > 25 kg/m\^2
* Associated with a participating church through membership or participation in a church activity
* Cleared by a Primary Care Provider (PCP-Doctor) to be a part of the study
* Not currently on weight loss medications
* Not pregnant or lactating
* Has not lost at least 10% of their body weight in the last 6 months
* Has not had bariatric surgery in the last 10 years
* Able to walk unassisted and continuously for 10 minutes
Exclusion Criteria:
* Adults unable to consent
* Adults unable to complete study measures in English
* Individuals who are not yet adults (infants, children, teenagers)
* Individuals who are pregnant or lactating
* Adults who have had a myocardial infarction (heart attack) or stroke without medical clearance from their primary care physician to participate in the study
* Adults who currently have type 1 or type 2 diabetes without medical clearance from their primary care physician to participate in the study | 2,545 |
Study Objectives
This clinical trial evaluates the use of novel decision support educational materials and services using health coaches. The study includes men newly diagnosed with low-risk prostate cancer. A 160 men will be recruited. Half of the men will receive a call from a health coach before their initial consultation visit with their urologist to review their treatment concerns and questions. The other half will receive usual care provided by the urologist, such as educational materials and services provided by the urologist.
Conditions: Decision Support Systems, Clinical, Prostate Cancer
Intervention / Treatment:
BEHAVIORAL: Decision Support Intervention (DSI)
| Inclusion Criteria:
* Male >=18 years of age and newly diagnosed prostate cancer (PCa) (within 3-months).
* Documentation of a low-risk PCa diagnosis as evidenced by clinical features of the following criteria:
* PSA test at diagnosis <=15 ng/ml
* Localized PCa (cT1/T2,N0,M0)
* Biopsy Gleason grade 2-6 OR (or 3+4 AND <=33% cores are positive for adenocarcinoma)
\*\*\*A minimum of 10 diagnostic cores taken by a systematic directed approach. Sampling may be obtained by target transrectal ultrasound (TRUS) or MRI imaging.
* No treatment yet
* No previous radiation or simultaneous use of androgen deprivation
* Prior use of 5-alpha reductase inhibitor is allowed if they have been stopped for 6 or more months and biopsy performed when patient was not taking the drug
* English language proficient and ability to provide informed consent
* Managing urologist considers them a candidate for active surveillance
* Written informed consent (and assent when applicable) obtained from subject and ability for subject to comply with the requirements of the study, including the ability to read and speak English.
Exclusion Criteria:
* Participants will be ineligible if they:
1. have pursued any active therapy for prostate cancer will be excluded;
2. are unable to read/speak English; or
3. if their managing urologist does NOT deem them as a candidate for active surveillance. | 1,482 |
Study Objectives
The purpose of this study is to evaluate the immunogenicity and safety of three consecutive lots of bivalent HPV (Type 16,18) vaccine (Pichia pastoris) in healthy female subjects aged 9 - 30 years, and demonstrate the non-inferiority of the candidate HPV vaccine manufactured at commercial scale compared with a pilot scale.
Conditions: HPV Infection
Intervention / Treatment:
BIOLOGICAL: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris)
| Inclusion Criteria:
* 9-30 healthy female able to provide legal identification.
* Written informed consent had to be obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent had to be obtained from a parent or legal guardian of the subject and, in addition, the subject had to sign and personally date a written informed assent).
* Women of child-bearing age(WOCBA): Subject had to have a negative urine pregnancy test, no plan to be pregnant in 7 months, and agree to use adequate contraceptive precautions during study period.
Exclusion Criteria:
* Subject has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial.
* History of abnormal cervical screen test result (ASC-US or worse) or history of genital warts.
* History of severe allergic reaction that required medical intervention.
* History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines.
* Pregnant or breastfeeding, or within 6 weeks after the end of pregnancy.
* Fever prior to vaccination (auxiliary temperature ≥37.3 °C).
* Hypertension (physical examination systolic blood pressure 140mmHg and or diastolic blood pressure 90mmHg.
* Received live attenuated vaccine within 15 days before vaccination or subunit or inactivated vaccine within 7 days.
* Received immunoglobulin and/or blood product 3 months prior to the first vaccination.
* Acute diseases or acute stage of the chronic diseases within 3 days preceding the vaccination.
* According to the judgment of the investigator, subject has or had any other symptoms, medical history and other factors that are not suitable for participating in this clinical trial. | 10,783 |
Study Objectives
This is a pilot study of Onconzene Microspheres for intra-arterial delivery of doxorubicin for the treatement of patients with unresectable hepatocellular cancer.
Conditions: Hepatocellular Cancer
Intervention / Treatment:
OTHER: Oncozene-DEB-TACE
| Inclusion Criteria:
* Patients must have a diagnosis of Hepatocellular carcinoma confirmed by at least one of the following: a) histological confirmation; b) imaging results consistent with cirrhosis and at least one solid liver lesion of >2cm with early enhancement and delayed washout (AASLD criteria for diagnosis of HCC); c) Alpha fetoprotein level >400ng/mL and evidence of at least one solid liver lesion >2cm, regardless of specific imaging characteristics on MRI.
* Tumor not suitable for resection at the time of study entry. (Transplant eligible patients are allowed)
* Age ≥ 18 years.
* Performance status ECOG PS 0-1 (Eastern Cooperative Oncology Group Performance Status).
* Child Pugh Score A only
* Adequate organ and marrow function as defined below:
* leukocytes ≥ 3,000/mcL (Measurement and Calibration Lab)
* absolute neutrophil count ≥ 1,500/mcL
* platelets ≥ 75,000/mcl
* total bilirubin ≤ 3.0
* AST (Aspartate Aminotransferase)(SGOT)/ALT (Alanine Aminotransferase)(SPGT) ≤ 5 X institutional upper limit of normal
* creatinine ≤ 2.0
* INR (International Normalized Ratio) ≤ 1.8
* Albumin ≥ 2.8
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
* Has not undergone a hysterectomy or bilateral oophorectomy
* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
* Absence of occlusive thrombus in the main portal vein
* Life expectancy of at least 6 months
* Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:
* Chemotherapy or radiotherapy within 4 weeks prior to entering the study or those with residual treatment related toxicity of greater than grade 1 not addressed in inclusion criteria.
* Any concurrent therapy for HCC including concurrent investigational agents.
* Subjects with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to doxorubicin or other agents used in study.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
* Child-Pugh status B or C
* Encephalopathy no adequately controlled medically
* Known cardiac ejection fraction <50%
* Tumor involving >50% of the liver
* Infiltrative form of HCC on imaging; If there is at least one measurable lesion per mRECIST criteria and otherwise patient is eligible for the study, the patient can be enrolled.
* Extensive extrahepatic spread of hepatocellular carcinoma. Patients with limited metastatic disease may be enrolled as defined as
* lymph node disease
* pulmonary nodules <5 mm in size
* 1-3 bone metastases
* Active gastrointestinal bleeding
* Evidence of uncontrollable bleeding diathesis
* Any contra-indication to angiography
* Any known contra-indication to chemoembolization according to the treating physician | 31,453 |
Study Objectives
Patients with extensive and bulky disease are often those whose initial surgery is delayed after 3 or 4 cycles of neo-adjuvant chemotherapy.
In that case, there is, indeed, some concern to administer bevacizumab during the chemotherapy surrounding the interval debulking surgery due to the long half life (14- 21 days) of this monoclonal antibody and the interference of anti angiogenic agents with wound healing.
Vargatef® (Nintedanib) might offer a better alternative to bevacizumab in the neo-adjuvant setting. Vargatef® (Nintedanib) has a much shorter half-life of 7 to 19 hours. Preliminary experience in cancer did not show a trend for increased incidence of fistula or bowel perforation. For more details please refer to the investigator drug brochure for Vargatef® (Nintedanib).
This trial will compare progression-free survival and surgical complications of 188 patients with FIGO stage IIIC/IV treated in first line with either neo-adjuvant chemotherapy (carboplatin \& paclitaxel) and interval debulking surgery or the same treatment + Vargatef® (Nintedanib).
Conditions: Ovarian Cancer
Intervention / Treatment:
DRUG: vargatef, DRUG: placebo
| Inclusion Criteria:
* First diagnosis of histological confirmed (cytology alone excluded) epithelial ovarian cancer, fallopian tube or primary peritoneal cancer. Histology should be obtained by laparoscopy (or by laparotomy),
* FIGO-Stages IIIC - IV,
* ECOG performance status < 2,
* Life expectancy of at least 6 months,
* Primary debulking surgery denied and maximum surgical effort of cytoreduction with the goal of no residual disease planned as interval debulking surgery,
* Interval between diagnosis and enrolment (informed consent) ≤ 8 weeks,
* Adequate hepatic, renal and bone marrow functions:
Platelets > 100 000 /μL, Hemoglobin > 9.0 g/dL, Absolute Neutrophil Count (ANC) > 1500/μL, Prothrombin time and/or partial thromboplastin time < 50% deviation from normal limits in the absence of therapeutic anticoagulation, Proteinuria < CTCAE grade 2, Total bilirubin ≤ upper limit of normal (ULN), ALT and/or AST ≤ 2.5 x ULN, Glomerular filtration rate >40 mL/min,
* Females, age 18 years or older,
* Patient has given written informed consent,
Exclusion Criteria:
* Histological diagnosis of malignant tumour of non-epithelial origin (e.g. germ cell tumour, malignant mixed mullerian tumour, sex cord-stromal tumour) of the ovary, the fallopian tube or peritoneum or borderline tumour of the ovary (tumour of low malignant potential),
* Non-healing wound, ulcer (intestinal tract, skin) or bone fracture,
* Clinical symptoms or signs of gastrointestinal obstruction,
* History of major thromboembolic event, defined as:
* Pulmonary embolism (PE) within 6 months prior to enrolment,
* Recurrent pulmonary embolism (history of at least 2 events),
* History of at least 2 unprovoked (without a transient or reversible risk factor) events of proximal deep venous thrombosis,
* Prior thrombosis or thromboembolic event in the presence of an inherited coagulopathy (including deficiency of antithrombin, deficiency of protein C or protein S, Factor V Leiden mutation, Prothrombin G20210A mutation),
* Patients with perioperative thrombosis including proximal deep vein thrombosis (DVT) or thrombosis of visceral vessels not associated with pulmonary embolism may be included in the trial if stable therapeutic anticoagulation is documented,
* Known inherited or acquired bleeding disorder,
* Significant cardiovascular diseases, including:
* Hypertension not controlled by medical therapy,
* Unstable angina within the past 6 months,
* History of myocardial infarction within the past 6 months,
* Congestive heart failure > NYHA II,
* Clinically relevant cardiac arrhythmia
* Peripheral vascular disease Fontaine stage ≥3,
* Clinically relevant pericardial effusion (e.g. pericardial effusion with echocardiographic or clinical signs of haemodynamic impairment),
* History of a cerebral vascular accident, transient ischemic attack or subarachnoid hemorrhage within the past 6 months,
* Serious infections in particular if requiring systemic antibiotic (antimicrobial, antifungal) or antiviral therapy, including HIV-infection, hepatitis B and/or C infection,
* Poorly controlled diabetes mellitus or other contraindication to high dose corticosteroid therapy,
* Clinical symptoms of brain metastases and/or diagnosis of brain metastases on imaging,
* Pre-existing sensory or motor neuropathy CTCAE ≥ 2, except due to trauma,
* Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug,
* Other malignancy diagnosed within the past 5 years, except:
* non-melanomatous skin cancer (if adequately treated),
* cervical carcinoma in situ (if adequately treated),
* carcinoma in situ of the breast (if adequately treated),
* prior or synchronous endometrial cancer (if adequately treated), provided the following criteria are met:
* Disease stage FIGO ≤ IB,
* No more than superficial myometrial invasion,
* Not poorly differentiated (less than grade 3, no papillary serous or clear cell histology),
* Prior systemic therapy for ovarian cancer (e.g. chemotherapy, monoclonal antibody therapy, oral targeted therapy, hormonal therapy),
* Prior radiotherapy to the abdomen or prior radiotherapy to an extra-abdominal target volume that would bear the risk of increased toxicity of chemotherapy,
* Hypersensitivity to Vargatef® (Nintedanib) and/or the excipients of the trial drugs,
* Serious illness or concomitant non-oncological disease such as neurologic, psychiatric or infectious disease, active ulcers (gastrointestinal tract, skin) or a laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study,
* Patients with preserved reproductive capacity who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner) during the trial and for at least twelve months after end of active therapy,
* Pregnancy or breast feeding,
* Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule,
* Active alcohol or drug abuse,
* Any contraindications for therapy with paclitaxel or carboplatin, e.g. a history of severe hypersensitivity reactions to paclitaxel or platinum-containing compounds and their excipients, or other drugs formulated with Polyoxyl 35 Castor Oil - ELP,
* Treatment with other investigational drugs or participation in another clinical trial testing a drug within the past four weeks before start of therapy or concomitantly with this trial. | 14,183 |
Study Objectives
Upon the completion of aggressive chemotherapy and radiation for curative intent cancers, many cancer survivors suffer from a myriad of symptoms ranging from physical symptoms such as hot flashes, insomnia, and fatigue to psychosocial symptoms including depression and anxiety. Mindfulness Based Cancer Recovery (MBCR) is a type of mind-body intervention. Mind-body interventions are defined as practices or interventions that focus on the connection and integration of the mind and body and the ability for these connections to effect changes on physical, emotional and spiritual levels for the purpose of promoting health and well being.
Conditions: Breast Cancer, Colorectal Cancer, Ovarian Cancer, Uterine Cancer
Intervention / Treatment:
BEHAVIORAL: Mindfulness Based Cancer Recovery
| Inclusion Criteria:
* Stage I-III breast cancer, gynecologic cancer or colorectal cancer
* Cancer survivor at least 18 years of age at the time of study enrollment
* Completed chemotherapy within the past six months at the time of consent (adjuvant hormone therapy is allowed)
Exclusion Criteria:
* Psychologic disease in which informed consent cannot be obtained from the subject
* Need for ongoing chemotherapy and/or radiation therapy | 18,826 |
Study Objectives
The purpose of this study is to reduce the side-effects from anti-leukemia therapy. The therapy in this study is based upon treatment information learned from prior clinical research programs as well as from laboratory research.
Conditions: Acute Lymphoblastic Leukemia
Intervention / Treatment:
DRUG: prednisone, DRUG: dexamethasone, DRUG: doxorubicin, DRUG: E. coli asparaginase, DRUG: vincristine, DRUG: methotrexate, DRUG: Leucovorin, DRUG: Asparaginase, DRUG: cytarabine, DRUG: Methotrexate/Hydrocortisone
| Inclusion Criteria:
* Acute lymphoblastic leukemia excluding known mature B-cell ALL by the presence of any of the following: surface immunoglobulin, L3 morphology, t(8;14) (q24;q32), t(8;22) or t(2;8)
* Age > 12 months but less than 18 years
Exclusion Criteria:
* Prior therapy except, 1 week of steroids, or emergent radiation therapy to the mediastinum
* Known HIV positive | 34,319 |
Study Objectives
The purpose of this study is to determine whether there is any difference of the pharmacokinetics of two taxane formulations, paclitaxel injection and liposomal paclitaxel in Chinese cancer patients with solid tumors.
Conditions: Cancer
Intervention / Treatment:
DRUG: Liposomal paclitaxel, DRUG: Paclitaxel
| Inclusion Criteria:
* Eligible patients must have histologically confirmed solid tumors of advanced stages
* Patients who are suitable for being treated with liposomal paclitaxel only
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
* Patients who are expected to be alive for at least 3 months
* Adequate hematologic, hepatic and renal functions
* Adequate other organ functions as defined by the protocol
* No prior systemic chemotherapy at least 4 weeks before the recruitment
* No previous anaphylactic reaction to hormone.
Exclusion Criteria:
* Allergy to any study medication
* Serious complication that would compromise the patient's ability to complete the study
* Grade ≥1 neuropathy using NCI CTCAE version 3.0 criteria
* Pregnancy or breast feeding | 22,379 |
Study Objectives
This phase I trial studies the side effects and best dose of R-(-)-gossypol acetic acid when given together with lenalidomide and dexamethasone and to see how well it works in treating patients with multiple myeloma, also known as plasma cell myeloma, that has come back after a period of improvement or has gotten worse after treatment. R-(-)-gossypol acetic acid may stop the growth of cancer cells by recognizing certain proteins and stimulating programmed cell death. Lenalidomide may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving R-(-)-gossypol acetic acid with lenalidomide and dexamethasone may work better in treating patients with multiple myeloma.
Conditions: Recurrent Plasma Cell Myeloma
Intervention / Treatment:
DRUG: Dexamethasone, OTHER: Laboratory Biomarker Analysis, DRUG: Lenalidomide, OTHER: Pharmacological Study, DRUG: R-(-)-Gossypol Acetic Acid
| Inclusion Criteria:
* Calculated creatinine clearance (using Cockcroft-Gault equation) >= 60 mL/min =<14 days prior to registration
* Absolute neutrophil count (ANC) >= 1000/mm\^3 =<14 days prior to registration
* Platelet count >= 75000/mm\^3 =<14 days prior to registration
* Hemoglobin >= 8.0 g/dL =<14 days prior to registration
* Patient must have relapsed and symptomatic multiple myeloma
* Measurable disease of multiple myeloma as defined by at least ONE of the following:
* Serum monoclonal protein >= 1.0 g/dL
* >= 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
* Serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
* Patients must have received ≥3 prior regimens for multiple myeloma
* Provide informed written consent
* Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
* Arm A Only (Closed): Willing to provide bone marrow and blood samples for correlative research purposes
Exclusion Criteria:
* Monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma
* Patients who received daratumumab, pomalidomide and dexamethasone as the most immediate prior line of therapy prior to trial enrollment (prior therapy with a daratumumab-based or a pomalidomide-based regimen are allowed and prior daratumumab-pomalidomide-dexamethasone is allowed so long as it was not given as the most immediate prior line of therapy prior to trial enrollment).
* Other malignancy requiring active therapy EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer
* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
* Pregnant women
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception
* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens (e.g., uncontrolled infection, uncompensated heart or lung disease)
* Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
* Prior severe skin reaction (toxic epidermal necrosis) with immunomodulating agents
* Major surgery =< 14 days before study registration
* Concurrent medical problems that preclude use of deep vein thrombosis (DVT) prophylaxis with lenalidomide treatment
* Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction =< 6 months prior to registration
* Immunocompromised patients and patients known human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
* Uncontrolled intercurrent illness including, but not limited to
* ongoing or active infection
* symptomatic congestive heart failure
* unstable angina pectoris
* cardiac arrhythmia
* or psychiatric illness/social situations that would limit compliance with study requirements
* Known allergy to any of the study medications, their analogues or excipients in the various formulations | 4,540 |
Study Objectives
A Phase II trial to demonstrate the response rate, using the Response evaluation criteria in solid tumours (RECIST) criteria, of patients with locally advanced / metastatic colorectal cancer treated with combination of irinotecan, oxaliplatin, UFT and cetuximab.
ENDPOINTS Primary: Objective response rate (RECIST) Secondary: Progression free survival (PFS), Overall survival (OS) Toxicity (CTCAE), Resectability of liver, lung and pelvic disease after chemotherapy, Time to progression (TTP).
POPULATION: The trial aims to recruit 50 patients with inoperable, metastatic colorectal cancer ELIGIBILITY: Histologically confirmed colorectal adenocarcinoma Normal haematology and adequate renal and liver function Written informed consent and able to attend follow-up for at least 3 months TREATMENT 4 weekly cycles of chemotherapy with alternating irinotecan (day 1) and oxaliplatin(day 15). Cetuximab every 2 weeks and oral UFT with Leucovorin for 3 weeks every 4 weeks.
DURATION First patient recruited April 2009. Accrual to take place over 24 months Follow-up will continue until death or for a minimum of 3 years
Conditions: Metastatic Colorectal Cancer
Intervention / Treatment:
DRUG: Cetuximab, DRUG: Irinotecan, DRUG: Oxaliplatin, DRUG: UFT
| Inclusion Criteria:
* Histologically confirmed adenocarcinoma of the colon or rectum.
* Patients must not have a mutation of K-ras
* Inoperable metastatic or locoregional disease (synchronous or recurrence)
* No previous chemotherapy for established metastatic disease (adjuvant chemotherapy must have been completed more than 6 months prior to trial entry)
* Measurable or evaluable disease
* Bone marrow function: neutrophil count >1.5 x109/l and platelet count >150 x109/l
* Hepatobiliary function: serum bilirubin <1.5 x upper limit of normal (ULN); ALP <5 x ULN; transaminase (AST or ALT) <3 x ULN.(≤ 5 if liver mets are present)
* Renal function: estimated creatinine clearance >50 ml/min, or measured Glomerular filtration rate (GFR) (EDTA or creatinine clearance) in normal range
* ECOG performance status 0-1 and considered fit and able to undergo all possible treatments
* For women of child-bearing potential a negative pregnancy test is required and adequate contraceptive precautions such as a sheath for their partner must be used
* For men - adequate contraception such as a sheath must be used
* Patients must give written, informed consent
* Life expectancy ≥ 3 months.
Exclusion Criteria:
* Patients that have a K-ras mutation
* Concurrent uncontrolled medical illness, or other previous or current malignant disease likely to interfere with protocol treatments or comparisons
* Partial or complete bowel obstruction
* Prior EGFR antibody therapy
* Age <18
* Chronic diarrhoea or inflammatory bowel disease
* Known Pyruvate Dehydrogenase Phosphatase (DPD) deficiency
* Gilbert's syndrome or other congenital abnormality of biliary transport
* Previous transplant surgery, requiring immunosuppressive therapy
* Regular / uncontrolled angina or cardiac arrhythmias
* Clinically relevant coronary artery disease. History of Myocardial infarction in the last 12 months
* Previous investigational agent in the last 4 weeks
* Metastatic disease to brain
* Any pregnant or lactating women
* Patients receiving therapy with haloginated antiviral drugs (eg: sorivudine)
* Patients who have experienced life-threatening toxicities with fluoropyrimidines treatment
* Patients suffering from any condition that may affect the absorption of UFT or folinic acid.
* Patients with known deficiency of or are on inhibitors of cytochrome P450 2A6
* Patients who have previously had radiotherapy to the abdomen or pelvis in the last 6 months
* Any medical or psychological condition that in the opinion of the investigator would not enable the patient to complete the study or knowingly give informed consent | 2,950 |
Study Objectives
Magnetic resonance imaging (MRI) is the method of choice in breast cancer to perform the loco-regional staging and direct the treatment.
European Guidelines (EUSOMA) currently recommend MRI for initial evaluation and assessement of the neoadjuvant chemotherapy (NAC) response, for breast cancer. The standard of care consists of realizing a MRI before the start of the NAC and another one after it's ended, six months later.
There is currently no consensus on the realization of an interval MRI for early assessment of the chemosensitivity of the tumor. It would allow though alterations in the therapeutic regimen in the event of a non response. Similarly, there is no consensus on when this interval MRI should be performed.
Some recent studies suggest that Diffusion-weighted Magnetic Resonance Imaging is interesting for the evaluation of the early response. However, these are preliminary studies with quantitative measures realized by the region of interest (ROI) method. A response to neoadjuvant chemotherapy results in elevated values of apparent diffusion coefficients (ADC).
The investigator's goal for this study is to evaluate the reliability of diffusion as tumor biomarker. Therefore, they will study the quantitative analysis of the diffusion-weighted magnetic resonance sequences in the pre-therapeutic assessment and the early and late follow-up of breast cancers under neoadjuvant treatment (chemotherapy, hormonotherapy...) within the CHU Brugmann hospital. The results of this analysis will be compared with the MRI results obtained at the end of the treatment and with the histology of the initial biopsy and the surgical specimen.
The expected benefits are:
* to establish correlations between apparent diffusion coefficients (ADC) values and histology
* to observe changes in the ADC according to the type of response: ADC increase in the event of partial response, ADC stability in the event of non response, ADC decrease in the event of a progression, absence of restriction in the event of a complete response.
* to confirm that diffusion weighted MRI within a short interval (after one cure, at one month) has a predictive value for the neoadjuvant chemotherapy (NAC) response.
Conditions: Breast Cancer
Intervention / Treatment:
DEVICE: Diffusion-weighted Nuclear Magnetic Resonance Imaging (MRI)
| Inclusion Criteria:
* Breast cancer
* Neo-adjuvant therapy indication
* Performance status from 0 to 2
Exclusion Criteria:
* Contraindications to magnetic resonance imaging (pacemaker, nerve stimulator, cochlear implant, major claustrophobia)
* Absence of histological results
* Disruption of the neo-adjuvant therapy | 7,510 |
Study Objectives
This study is designed to test (1) whether the BEACOPP dosage can be reduced to baseline in the last 4 cycles without loss of effectiveness, and (2) whether consolidating irradiation is necessary following effective chemotherapy.
Conditions: Hodgkin´s Lymphoma
Intervention / Treatment:
DRUG: Cyclophosphamide, DRUG: Adriamycin, DRUG: Etoposide, DRUG: Procarbazine, DRUG: Prednisone, DRUG: Vincristine, DRUG: Bleomycin, PROCEDURE: radiation therapy
| Inclusion Criteria:
* Hodgkin´s lymphoma (histologically proven)
* CS(PS) IIB with one or both of the risk factors:
1. bulky mediastinal mass (> 1/3 of maximum transverse thorax diameter)
2. extranodal involvement
* CS(PS) III, IV
* written informaed consent
Exclusion Criteria:
* Leukocytes <3000/microl
* Platelets <100000/microl
* Hodgkin´s Disease as "composite lymphoma"
* Activity index (WHO) < grade 2 | 6,804 |
Study Objectives
During general anesthesia, airway closure and the formation of atelectasis impair oxygenation. During one-lung ventilation, large tidal volumes are used to resume atelectasis with a risk of regional over distension and Ventilator-Induced Lung Injury (VILI). The reduction in TV should reduce the occurrence of VILI but lead to a consistent alveolar derecruitment. This harmful effect may be counteracted by PEP. We, therefore, study the impact on oxygenation, of increasing PEP during OLV, in order to maintain alveolar recruitment when TV is reduced.
Conditions: Lung Neoplasms, Pulmonary Disease
Intervention / Treatment:
PROCEDURE: One-Lung ventilation, PROCEDURE: One-Llung ventilation
| Inclusion Criteria:
* Age> 18 years
* Open-chest thoracotomy for pulmonary resection
* oral consent
Exclusion Criteria:
* Severe obstructive disease (FEV1 or FEV1 /CV < 70%)
* Patient who don't tolerate a one-lung ventilation | 7,834 |
Study Objectives
The purpose of this study is to determine the ability of a specific imaging method, termed Diffuse Optical Spectroscopic Imaging, to provide metabolic and functional information which can be used to predict overall response to preoperative (neoadjuvant) chemotherapy in patients with sarcomas. Sarcoma patients face comparatively poor response rates to chemotherapy and early, non-invasive indications of response could provide physicians with the information necessary to make evidence-based changes in treatment strategies. Patients who do not demonstrate early signs of response would be spared the unnecessary side-effects of an ineffective chemotherapy regimen, and could either be switched to a different regimen or undergo surgery
Conditions: Sarcoma
Intervention / Treatment:
| Inclusion Criteria:
* Any subjects with no current or previous history of sarcoma are eligible to be a normal volunteer
* Any subject with a sarcoma neoplasm is eligible to be measured for aim 2 of the study
* Only patients undergoing neoadjuvant chemotherapy for sarcoma are eligible for Aim 3 of the study
Exclusion Criteria:
* Age less that 18 year old | 31,612 |
Study Objectives
The primary objectives are to:
1.1 identify and compare the experiences of minority and nonminority caregivers, including the prevalence and severity of physical (fatigue, sleep disturbance) and psychologic (depression, anxiety, stress) symptoms and their influence on caregiver symptom burden; and to
1.2 assess the relationship between caregiver's symptoms (physical and psychologic) and the patient's symptom's at multiple time points over the patient's treatment regimen for advanced solid tumors (lung, breast, cervical, and others).
A secondary objective is to:
1.3 describe the experience of being a minority (African American/Black or Latino) or nonminority person caring for a medically underserved patient with advanced solids tumors (lung, breast, cervical, or others) over the course of the patient's treatment regimen and follow-up clinic visits.
Conditions: Psychosocial
Intervention / Treatment:
BEHAVIORAL: Phenomenological Interviews, BEHAVIORAL: Quantitative Interviews
| Inclusion Criteria:
* Caregiver inclusion criteria includes: provides care and/or assistance to a patient receiving new or current treatment - Single or combined chemotherapy, radiotherapy, and/or targeted therapy for advanced solid tumors (lung, breast, cervical, and other).* 18 years of age or older;* self-identified as African-American/Black, Latino, or white, non-Latino;* able to speak English or Spanish (as applicable);* able to read and complete forms or be willing to have the forms read to them by a trained interviewer;* accessible through personal or telephone contact for the duration of the study.* Patient inclusion criteria: Receiving new or current treatment - Single or combined - chemotherapy, radiotherapy, and/or targeted therapy for advanced solid tumors (lung, breast, cervical, and others). Criteria 2-6 are the same as listed under Caregiver Criteria.
Exclusion Criteria: None | 29,925 |
Study Objectives
Follicular lymphomas are a subgroup of B-cell non-Hodgkin lymphomas, accounting for 15% to 30% of newly diagnosed lymphomas.1-3 Median survival varies from 5 to 10 years depending on the prognostic factors at diagnosis and response to first-line therapy.4-6 Whatever the treatment, no plateau appears on survival curves, and virtually all patients relapse; follicular lymphomas are ultimately progressive, and fatal.2,3,5 No reference first-line treatment is clearly defined. One of the most active therapies is still doxorubicin-based chemotherapy with or without interferon.7-9 New therapeutic approaches including purine analogs and anti-CD20 monoclonal antibody are promising and are progressively included in the management of these lymphomas.2,3,10-13 The role of high-dose therapy (HDT) as a salvage treatment for patients with relapsing follicular lymphoma is demonstrated by some authors; several reports have shown the superiority of HDT followed by autologous stem-cell transplantation, purged or unpurged, compared with conventional chemotherapy in terms of no relapse and overall survival.14-18 Only a few reports have been published showing HDT results as a first-line treatment for poor-risk patients with follicular lymphoma, and the results remain controversial.19-26 These data prompted the French Groupe Ouest-Est des Leucémies et Autres Maladies du Sang (GOELAMS) to conduct a prospective randomized trial using patients with newly diagnosed follicular lymphoma with a high tumor burden. A combined doxorubicin-based chemotherapy associated with interferon was compared to front-line HDT followed by purged autologous stem-cell transplantation.
Conditions: Follicular Lymphoma
Intervention / Treatment:
PROCEDURE: chemotherapy, PROCEDURE: high dose therapy and autologous stem cell transplantation
| Inclusion Criteria:
* Age 18-60 years old
* Follicular Lymphoma B, C or D (Working Formulation)
* No previous treatment
* Seronegativity HIV
* ECOG performance status less than or 2
* eligible for autologous stem-cell transplantation
* Stage II , III or IV Ann Arbor Classification
* criterias of high tumor burden
* Patient's written informed consent
Exclusion Criteria:
* Age less than 18 years old or more than 60 years old
* Other type of lymphoma
* Stage less than 3 or III-IV (faible masse)
* Seropositivity HIV
* Patients with a history of another malignancy except basal cell skin cancer or in situ uterus cancer | 26,472 |
Study Objectives
Comparing changes in biomarkers from a diagnostic core needle biopsy to surgical pathology specimen or repeat core needle biopsy.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Imipramine
| Inclusion Criteria:
* Participants may be female or male who are 18 years old or older.
* Ability to consent to treatment - patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
* Previously untreated breast cancer determined by a core needle biopsy showing invasive ductal carcinoma or invasive lobular carcinoma.
* A prior, unrelated, breast cancer is allowed.
* All breast cancers with possibility for surgical excision will be included.
* Patient must be able to take oral medications. Patients may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of the study drug.
* Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (β-hCG) pregnancy test result within 14 days prior to the first dose of imipramine.
* Patients must be eligible for surgical resection of their breast cancer or repeat biopsy after completing treatment.
* Patients must have a complete history and physical examination within 30 days prior to registration.
* Patients must have a performance status of ECOG 0, 1, 2.
* Tissue block of initial biopsy specimen is available.
* Patient may not be concurrently enrolled in another investigational drug treatment study.
Exclusion Criteria:
* Known diagnosis of major depressive disorder, bipolar depression or psychosis
* ECOG 3 or 4
* Age >= 70 years
* Renal impairment defined as EGFR <30
* Hepatic impairment as judged by clinical investigator or bilirubin >2
* As judged by the investigator, severe uncontrolled concurrent medical conditions, psychiatric illness or social condition that would limit compliance with study requirements
* History of cardiac disease (arrhythmia, conduction abnormality, congenital prolonged QT syndrome, or prolonged QTc rhythm noted during initial EKG >480 ms)
* Current use of SSRI, SNRI, MAO inhibitor, tramadol or trazadone; or use of these agents within 14 days
* Inflammatory breast cancer
* Suicidal ideation or history of suicide attempt
* Myocardial infarction within 3 months of study initiation.
* Patients with Angle-Closure Glaucoma
* Pregnant or breast-feeding women. As there have been no well-controlled studies conducted with pregnant women to determine the effect of imipramine on the fetus. However, there have been clinical reports of congenital malformations associated with the use of the drug. | 4,496 |
Study Objectives
The purpose of this study is to provide treatment with lyophilized S95014 in pediatric patients with ALL who completed the CL2-95014-002 study during the induction phase and who are clinically benefitting from S95014 without major toxicity.
Conditions: Acute Lymphoblastic Leukemia
Intervention / Treatment:
DRUG: Lyophilized S95014
| Inclusion Criteria:
* Patient who completed the CL2-95014-002 study
* Patient currently receiving clinical benefit from previous treatment with S95014 as per investigator's judgment
* Signed informed consent and assent, when appropriate
* Highly effective contraception method
Non-inclusion Criteria:
* Unlikely to cooperate in the study
* Pregnant and lactating women
* Participant already enrolled in the study (informed consent signed)
* Prior surgery or bone marrow transplant related to the studied disease
* History of sensitivity to polyethylene glycol (PEG) or PEG-based drugs
* Psychiatric illness/social situation that would limit compliance with study requirements
* Group "E" and "T-HR" patients according to ALL-MB 2015 protocol classification
* Major safety issue due to previous S95014 administration (e.g. non recovery of safety parameters, serious hypersensitivity, serious pancreatitis, serious haemorrhage, serious thromboembolic event)
* Significant laboratory abnormality or uncontrolled intercurrent illness (e.g. life-threatening acute tumor lysis syndrome, symptomatic congestive heart failure, cardiac arrhythmia, severe or uncontrolled active acute infection) likely to jeopardize the patients' safety or to interfere with the conduct of the study, in the investigator's opinion | 17,679 |
Study Objectives
The subjects will be treated with a single dose of SP-SAP. They will receive the study drug SP-SAP via a percutaneous intraspinal catheter, they will be monitored for 4 hours and required to stay in the hospital for 24 hours for precautionary care. Their vital signs will be monitored and recorded immediately following the injection. After the catheter has been removed, the following assessments will be made physical exam including motor and sensory functions, and electrocardiogram. A neurologist will be available for consultation as needed.
Beginning dose of SP-SAP will be 1 -mcg for the first cohort.
Subsequent single patient dose cohorts as 2, 4, 8, 16, 32, 64 and 90 mcg intrathecally (into the spine). SP-SAP will be accrued and treated after four weeks observation for toxicities between cohorts.
Study duration will be up to 6 months from the start of SP-SAP administration.
Conditions: Terminally Ill, Histologically-confirmed Advanced Cancer, Pain, Intractable
Intervention / Treatment:
DRUG: Substance P-Saporin
| Inclusion Criteria:
* Age ≥ 18 years* Signed informed consent* Terminally ill cancer patients with intractable chronic pain in the pelvis, lower abdomen, back, or spine. "Terminal" refers to ≤ six-month life expectancy. "Intractable" is defined as pain uncontrolled with medications or procedures.* Minimal expected survival time of one month* ECOG Performance status of 0 - 3* Able to verbally report pain* Able to indicate pain on a VAS* Able to perform motor/sensory tests* Able to undergo a 4-h intrathecal catheter placement* Other therapeutic and palliative options have been exhausted
Exclusion Criteria:
* Concurrent therapy with an investigational agent* Concurrent radiation or chemotherapy* Pregnancy or failure to use effective contraception in fertile males or females, and breast-feeding females. For all female patients of child-bearing potential, a negative pregnancy test (serum or urine) within ten days before start of the study treatment must be obtained. Female patients must agree to use effective contraception, or must be surgically sterile, or must be postmenopausal. Acceptable forms of birth control are: spermicide with condom, diaphragm, or cervical cap, IUD-intrauterine device, birth control pills, or abstinence. The rhythm method or Plan B are not considered acceptable forms of birth control. Male patients must agree to use effective contraception or be surgically sterile.* Diagnosis of intractable chronic pain of the chest, head, neck or upper extremities.* Active infection or ulcer at the lumbar injection site* Inability to receive lumbar intrathecal injection because of other factors* Diagnosis of meningitis or encephalitis* Other severe, acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or, in the judgment of the investigator, would make the patient inappropriate for the study* Comorbidities at particular risk (i.e., CNS, CNS metastases, hydrocephalus or coagulopathy) | 12,586 |
Study Objectives
The purpose of this study is to evaluate the safety, tolerability and clinical activity of RO6870810 in combination with venetoclax and when co-administered with rituximab in participants with relapse/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and/or high-grade B-cell lymphoma with myelocytomatosis oncogene (MYC) and/or B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) gene rearrangements (HGBL-DH/TH).
Conditions: Diffuse Large B-cell Lymphoma, High-Grade B-cell Lymphoma
Intervention / Treatment:
DRUG: RO6870810, DRUG: Venetoclax, DRUG: Rituximab
| Inclusion Criteria
* Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
* Life expectancy >3 months as per investigator's assessment.
* Part 1 and Part 2 Group 1: Participantts with diffuse large B-cell lymphoma (DLBCL) relapsed or refractory to ≥ 1 course of chemotherapy including an anti-CD20 monoclonal antibody, and not eligible for autologous stem cell transplantation (ASCT) (including due to chemorefractory disease). Participants with transformed FL are eligible, provided DLBCL or HGBL-DH/TH histology is biopsy-confirmed prior to study entry and a treatment regimen as described above has been administered. The Sponsor retains the option to limit the number of participants enrolled with transformed FL.
Part 2, Group 2: Patients identified with DE-DLBCL (expression MYC ≥40%, BCL2 > 50%) and or HGBL-DH/TH, relapsed or refractory to >= 1 course of chemotherapy including an anti-CD20 monoclonal antibody, and not eligible for ASCT (including due to chemorefractory disease). Patients with transformed follicular lymphoma (FL) are eligible, provided DE-DLBCL and/or HGBL-DH/TH histology is biopsy-confirmed prior to study entry and a treatment regimen as described above has been administered. The Sponsor retains the option to limit the number of participants enrolled with transformed FL.
* Part 1 and Part 2: Willing to provide the protocol specified tumor biopsy(ies): at screening a fresh biopsy (if no archival biopsy tissue of less than 3 months prior to treatment and without intercurrent treatment is available); Part 2: Willing to provide an additional biopsy on Cycle 2 Day 15 (+ 2 days).
* Acceptable liver function, as specified below:
* Total bilirubin ≤ 2 times upper limit of normal (ULN). (Participants with known Gilbert's disease who has serum bilirubin ≤ 3 × ULN may be enrolled).
* Aspartate transaminase (AST; SGOT), alanine transaminase (ALT; SGPT) ≤ 2.5 × ULN, (or ≤ 5 × ULN if tumor involvement (liver) is present).
* Gamma-glutamyl transferase (GGT) alkaline phosphatase ≤ 2.5 × ULN.
* Acceptable renal function, as specified below:
* Creatinine clearance (CrCl) calculated by Cockroft-Gault formula of ≥ 60 mL/min.
* Acceptable hematologic status (growth factors cannot be used within the previous 7 days), as specified below:
* Absolute neutrophil count (ANC) ≥ 1000 cells/μL
* Hemoglobin ≥ 9 g/dL
* Platelet count ≥ 75,000 (platelets/μL)
* Uncontrolled symptomatic hypercalcemia.
* Acceptable coagulation status, as specified below:
* Prothrombin time (PT) and partial thromboplastin time (PTT) ≤ 1.2 × ULN (unless receiving anticoagulation therapy, if receiving anticoagulation therapy, eligibility will be based upon international normalized ratio \[INR\]).
* INR ≤ 1.6 (unless receiving anticoagulation therapy).
* If receiving warfarin: INR ≤ 3.0 and no active bleeding (i.e., no bleeding within 14 days prior to first dose of study therapy).
* Acceptable method of contraception
Exclusion Criteria
* Current central nervous system (CNS) lymphoma or leptomeningeal infiltration.
* New York Heart Association (NYHA) Class III or IV cardiac disease, myocardial infarction, within the past 6 months, unstable arrhythmia, or known pericardial disease.
* Fredericia-corrected QT interval (QTcF) >470 msec (female) or >450 msec (male), or history of congenital long QT syndrome.
* Any electrocardiogram (ECG) abnormality, which in the opinion of the Investigator would preclude safe participation in the study.
* Active, uncontrolled bacterial, viral, or fungal infections, within 7 days of study entry requiring systemic therapy.
* Clinically important respiratory impairment
* Grade ≥ 3 sensory or motor neuropathy.
* Any Grade >1 (according to the NCI CTCAE 4.03) adverse reaction unresolved from previous treatments and not readily managed and controlled with supportive care.
* Serious non-malignant disease that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
* History of progressive multifocal leukoencephalopathy (PML).
* History of other malignancy within 2 years prior to screening, except for ductal carcinoma in situ not requiring chemotherapy, appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, low-grade, localized prostate cancer (Gleason score ≤ 7) not requiring treatment or appropriately treated Stage I uterine cancer.
* Completion of ASCT within 100 days prior to Day 1 of Cycle1.
* Prior standard or investigational anti-cancer therapy, as specified below:
* Radio-immunoconjugate 4 weeks or 5 half-lives, whichever is longer prior to Day 1 of Cycle 1.
* Monoclonal antibody or antibody-drug conjugate (ADC) therapy within 3 weeks prior to Day 1 of Cycle 1.
* Radiotherapy, chemotherapy, or targeted small-molecule therapy within 2 weeks prior to Day 1 of Cycle 1.
* CAR T-cell therapy 30 days prior to Day 1 of Cycle 1.
* History of major solid organ transplant (i.e., heart, lungs, liver and kidney).
* History of an allogeneic bone marrow transplant.
* Major surgical procedure within 28 days prior to Day 1 of Cycle 1.
* Treatment with systemic corticosteroids ≥ 20 mg/day prednisone or equivalent, for non-lymphoma treatment reasons. For lower acceptable doses, documentation of a stable dose for at least 4 weeks prior to Day 1 of Cycle 1 is required.
18. Treatment with strong to moderate CYP3A inhibitors or moderate CYP3A inducers within 7 days prior to the first dose of study treatment.
* Treatment with strong CYP3A inducers within 14 days prior to the first dose of study treatment of RO6870810/venetoclax.
* Consumption of grapefruits, grapefruit products, Seville oranges (including marmalade that contains Seville oranges), or star fruit within 3 days prior to the first dose of venetoclax.
* Participants who are currently receiving any other investigational agent ((other than anti-cancer therapy as specified in exclusion criteria number 13) or have received an investigational agent within 30 days or 5 half-lives prior to Day 1 of Cycle 1, whichever is longer.
* Prior treatment with small molecule bromodomain and extra terminal (BET) family inhibitor.
* Known to be human immunodeficiency virus (HIV) positive.
* Presence of positive test results for hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (HcAb) (for participants receiving regimen including rituximab)
* Pregnant or breastfeeding female.
* Significant allergy to a biological pharmaceutical therapy that, in the opinion of the Investigator, poses an increased risk to the participant.
* Uncontrolled cancer pain. Participants requiring pain medication must be on a stable regimen at study entry. Symptomatic lesions amenable to palliative radiotherapy should be treated prior to enrollment.
* History of severe allergic or anaphylactic reaction to humanized or murine monoclonal antibodies (for participants receiving regimen including rituximab).
* Known sensitivity or allergy to murine products or any component of RO6870810, venetoclax, or rituximab. | 26,869 |
Study Objectives
The purpose of this study is to determine the response rate of patients with refractory, relapsed or poor risk AML expressing FLT-3 activating mutations, when administered CEP-701 at a dosage of 60 mg 2 times a day.
Conditions: Leukemia, Myeloid
Intervention / Treatment:
DRUG: CEP-701 60mg, DRUG: Cep-701 80mg, DRUG: Cep-701 40mg
| INCLUSION CRITERIA:
* patient must have confirmed diagnosis of refractory or relapsed AML that expresses a FLT-3 mutation
* patient must have life expectancy of more than 2 months
* patient must be fully recovered from reversible side effects of previous therapy for cancer
EXCLUSION CRITERIA:
* total bilirubin, ALT or AST greater than 2 times upper limit of normal
* patient <65 years of age with estimated creatinine clearance less than 60 mL/min; patient >65 years of age with serum creatinine > 1.5 times the upper limit of normal (ULN)
* received any investigational drug within past 4 weeks
* GI disturbance/malabsorption that may affect absorption of CEP-701
* HIV positive
* received NSAID within prior 14 days
* has active infection | 15,757 |
Study Objectives
The main purpose of this trial is to demonstrate the predictive value of the clinical diagnosis of clearance of Actinic Keratoses after treatment with Ingenol Mebutate using histopathological examination as the standard.
Conditions: Actinic Keratosis
Intervention / Treatment:
DRUG: Ingenol mebutate gel 0.05%
| Inclusion Criteria:
* Must be male or female and at least 18 years of age.
* Female patients must be on non-childbearing potential or if of childbearing potential then negative serum and urine pregnancy test and using effective contraception
* Ability to provide informed consent
* Subjects must have 5-9 clinically typical, visible and discrete AK lesions within a contiguous 25cm2 treatment area on the trunk and extremities except the back of the hand
* AK should be confirmed by histopathology of one of the AK's prior to inclusion
Exclusion Criteria:
* location of the selected treatment area within 5cm of an incompletely healed wound or within 10cm of a suspected basal cell carcinoma or squamous cell carcinoma
* undergone Cosmetic or therapeutic procedures
* use of acid-containing therapeutic products within 2cm of the selected treatment area in the 2 weeks prior to Visit 1
* use of topical creams/lotions, artificial tanners or topical steroids within 2cm of the selected treatment areas in the 2 weeks prior to visit 1.
* treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system within 4 weeks of visit 1
* treatment with 5-FU, imiquimod, diclofenac, ingenol mebutate of photodynamic therapy within 2cm of the treatment area in the 8 weeks prior to visit 1
* use of systemic retinoids
* those who are currently participating in any other interventional clinical trial
* females who are pregnant or are breastfeeding
* those known or suspected of not being able to comply with the requirements of the protocol or provide consent | 21,492 |
Study Objectives
The purpose of this study is to determine the safety and feasibility of the combination of decitabine given at a fixed dose with escalating doses of rapamycin in patients with relapsed or refractory acute myeloid leukemia.
Conditions: Acute Myeloid Leukemia
Intervention / Treatment:
DRUG: Decitabine, DRUG: Rapamycin
| Inclusion Criteria:
* Age greater than or equal to 18 years
* Diagnosis of AML according to WHO criteria except acute promyelocytic leukemia AND
* Refractory AML defined as a failure to achieve CR after 2 cycles of induction chemotherapy or persistence of > 40% bone marrow blasts after one cycle of chemotherapy induction OR
* Relapsed AML defined as any evidence of disease recurrence within 12 months of achieving first CR OR
* Relapsed AML after stem cell transplantation 100 days must have elapsed between transplant and emergence of recurrent AML
* ECOG performance status <3 (Appendix 1)
Exclusion Criteria:
* Abnormal renal function as evidenced by a calculated creatinine clearance ≤ 30ml/min (Cockcroft-Gault formula (Appendix 2)
* Abnormal liver function: Bilirubin >2.0 mg/dl, transaminase more than 2.5x the upper limits of normal
* Active systemic infection
* Known chronic liver disease
* Known diagnosis of human immunodeficiency virus infection (HIV)
* Patients who are post-allogeneic transplantation should not have active GVHD greater than grade 1 of skin
* Pregnant or breast feeding female subjects | 16,954 |
Study Objectives
This is a pilot study of Pazopanib in patients with FGFR2 Amplification or FGFR2 mutation Refractory solid tumors.
This study is a single-arm, pilot study of Pazopanib in subjects with Refractory solid tumors harboring FGFR2 Amplification or FGFR2 mutation Pazopanib 800mg will be administered orally once a day 28 days.Study treatment will be continued until objective disease progression.
To investigate the efficacy of Pazopanib in subjects with Refractory solid tumors harboring FGFR2 Amplification or FGFR2 mutation.
Conditions: Refractory Solid Tumors
Intervention / Treatment:
DRUG: pazopanib
| Inclusion Criteria:
* Provision of fully informed consent prior to any study specific procedures.* Patients must be ≥20 years of age.* FGFR2 amplification or FGFR2 mutation Refractory Solid Tumors that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.* ECOG performance status 0-2.* Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.* Adequate Organ Function Laboratory Values
* Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 100 x 109/L
* bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases)
* creatinine ≤1.5 x UNL* Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.* Adequate heart function.
Exclusion Criteria:
* Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.* Has known active central nervous system (CNS) metastases.* Has an active infection requiring systemic therapy.* Pregnancy or breast feeding* Patients with cardiac problem.* Any previous treatment with Pazopanib. | 33,259 |
Study Objectives
This phase I trial studies the side effects and best dose of tivantinib in treating younger patients with solid tumors that have returned after a period of improvement or have not responded to treatment. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Conditions: Childhood Solid Neoplasm
Intervention / Treatment:
OTHER: Laboratory Biomarker Analysis, OTHER: Pharmacological Study, DRUG: Tivantinib
| Inclusion Criteria:
* PART A: Patients on dose levels -1 or 1 must have a body surface area (BSA) >= 0.65 m\^2 at the time of study enrollment; patients on dose levels 2 or 3 must have a BSA >= 0.45 m\^2 at the time of study enrollment
* PART B: There is no minimum body surface area requirement for patients in part B
* Patients with relapsed or refractory solid tumors including central nervous system (CNS) tumors are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)
* Patients must have either measurable or evaluable disease
* Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
* Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; note: neurologic deficits in patients with CNS tumors must have been stable or improving for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
* Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy:
* Myelosuppressive chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)
* Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair
* Biologic (anti-neoplastic agent): At least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair
* Immunotherapy: At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines
* Monoclonal antibodies: At least 3 half-lives of the antibody after the last dose of a monoclonal antibody
* Radiation therapy (XRT): At least 14 days after local palliative XRT (small port); at least 150 days must have elapsed if prior total-body irradiation (TBI), craniospinal XRT or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation
* Stem cell infusion without TBI: No evidence of active graft vs. host disease and at least 84 days must have elapsed after transplant or stem cell infusion
* Patients may not have received prior therapy with tivantinib
* Peripheral absolute neutrophil count (ANC) >= 1000/mm\^3
* Platelet count >= 100,000/mm\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
* Patients with known bone marrow involvement will be eligible for study provided they meet the blood counts above (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity; at least 5 of every cohort of 6 patients with a solid tumor must be evaluable for hematologic toxicity for the dose escalation part of the study; if dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m\^2 or a serum creatinine based on age/gender as follows:
* 1 to < 2 years: 0.6 mg/dL
* 2 to < 6 years: 0.8 mg/dL
* 6 to < 10 years: 1.0 mg/dL
* 10 to < 13 years: 1.2 mg/dL
* 13 to < 16 years: 1.5 mg/dL (males); 1.4 mg/dL (females)
* >= 16 years: 1.7 mg/dL (males); 1.4 mg/dL (females)
* Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
* Serum glutamic pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =< 110 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L
* Serum albumin >= 2 g/dL
* All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
* Tissue blocks or slides must be sent; if tissue blocks or slides are unavailable, the study chair must be notified prior to enrollment
Exclusion Criteria:
* Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
* Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible
* Patients who are currently receiving another investigational drug are not eligible
* Patients who are currently receiving other anti-cancer agents are not eligible
* Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial
* Patients must not be receiving any of the following for at least 24 hours prior to enrollment: omeprazole, esoprazole, lansoprazole, pantoprazole, rifampin, omeprazole, fluvoxamine, or moclobemide
* Patients must not be receiving any of the following for at least 24 hours prior to enrollment: atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO), voriconazole, rifampicin, rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital, or St. John's Wort
* Nasogastric or G tube administration is not allowed; patients in part A must be able to swallow capsules
* Patients who have an uncontrolled infection are not eligible
* Patients who have received a prior solid organ transplantation are not eligible
* Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
* Patients with >= grade 2 bradycardia or with a known history >= grade 2 cardiac arrhythmia are not eligible | 762 |
Study Objectives
This project will use a community based participatory research orientation to develop a model for large scale "campaign" preventive healthcare interventions. The investigators have considerable expertise with cervical cancer screening and HPV vaccination. The investigators also have well tested methodologies for cervical cancer screening that are highly effective, including self-sampling for HPV and improved specimen transport systems. Therefore, the investigators will use these medical interventions as the model preventive health interventions for this project.
Conditions: Cervical Intraepithelial Neoplasia, Cervical Cancer, Cervical Neoplasm, Cervical Dysplasia, Human Papillomavirus
Intervention / Treatment:
BIOLOGICAL: Gardasil
| Inclusion Criteria:
Inclusion criteria (adult)
* Non pregnant women 30-45 years of age in Manchay, and in Iquitos, with female children or grandchildren ages 10-13 who they are willing to enroll in the study to receive Gardasil vaccination.* No screening or knowledge of the results of a Pap Test in the last 5 years* No hysterectomy* No prior pelvic radiation.* Willing to sign consent form
Inclusion criteria (children)
* Female children and grandchildren of a participating women ages 10-13 years* No acute illnesses (clinically evident according to vaccinating staff) - such as fever, nausea, vomiting, diarrhea* No previous vaccination with Gardasil* No reactions to previous dose in their vaccination series* No known yeast allergy* Willing to participate
Exclusion Criteria:
Exclusion criteria (adults)
Patients will be excluded in the study based on the following criteria:
* Males* Women younger than 30 years old and older than 45 years old.* Women without female children or grandchildren age 10-13 or who are unwilling to enroll their 10-13 year old female children or grandchildren to receive Gardasil.* Pregnant women.* Patients with known history of hysterectomy or radiation for a pelvic cancer.* Refusal to participate
Exclusion criteria (Children)
* Males* Girls younger than 10 years old, and older than 13 years.* acute illnesses (clinically evident according to vaccinating staff) - such as fever, nausea, vomiting, diarrhea* previous vaccination with Gardasil* reactions to a previous dose in their vaccination series* known yeast allergy* Refusal to participate | 32,015 |
Study Objectives
Qualitative data were collected from 5 General Practionners (GPs) focus groups, 24 patient interviews and 35 recorded consultations from 9 GPs to explore colorectal cancer (CRC) screening in France The qualitative data indicated that improvement was needed in patient-centered communication. Educational material was developed based on these triangulated data with two different scenarios to improve communication with patients: one for a compliant patient, another for a non compliant patient The hypothesis is that a brief intervention on GPs can improve the patients' participation rate to colorectal screening
Method : cluster randomized control trial (cluster unit : GPs practices) With a brief intervention on a randomized population of GPs in the district of Val d'Oise Inclusion criteria: GPs with a practice in the district of Val d'Oise and active in the colorectal mass screening
Conditions: Colorectal Cancer
Intervention / Treatment:
BEHAVIORAL: GPs communication skills and CRC screening
| Inclusion Criteria:
Inclusion of GPs practices: All GPs practices of the Val d'Oise department in France were eligible to participate GPs using complementary therapies occasionally were allowed to participate
Exclusion Criteria:
Exclusion of GPs practices : practices were excluded when doctors used exclusively complementary therapies (acupuncture therapy, homeopathy....)
* | 1,280 |
Study Objectives
This is a safety and tolerability study looking at the addition of avelumab, an immune checkpoint inhibitor, to standard therapy of temozolomide and radiotherapy in patients with newly diagnosed glioblastoma multiforme.
All patients will be receiving active therapy. Patients will begin the avelumab within 3 weeks of finishing their radiotherapy. Avelumab will be given at a dose of 10mg/kg IV every 2 weeks concomitantly with the monthly temozolomide. Avelumab will be continued for a total of 52 weeks.
Conditions: Glioblastoma Multiforme of Brain
Intervention / Treatment:
BIOLOGICAL: avelumab
| Inclusion Criteria:
* Signed informed consent.* Age ≥ 18 years.* Present with newly diagnosed supratentorial Glioblastoma (GBM) with a tissue diagnosis that has been established following either a surgical resection or biopsy. This includes treatment-naïve -(chemotherapy and radiotherapy)- patients with prior diagnosis of a lower grade astrocytoma that has been upgraded to a histologically verified GBM.* Karnofsky performance score of 70 or higher.* Patients entering the study must be on a stable dose of up to 12 mg (maximum) of Dexamethasone (or equivalent) daily for symptoms related to cerebral edema. Following the first dose of avelumab, the duration of treatment with the current dose of dexamethasone (maximum 12 mg/day) or equivalent, should be no more than 7 consecutive days. The investigator(s) should make every effort to taper the dexamethasone as soon as symptom improvement allows to the lowest tolerable dose that controls the CNS symptoms.* Will be or is undergoing or has received the standard therapy of chemo radiation therapy (60Gy in 30 fractions of 2Gy/day with concurrent temozolomide of 75mg/m2 per day PO) no more than 21 days ago.* Has not yet begun but will begin standard monthly temozolomide therapy.* Patient must have at least 1 formalin fixed paraffin embedded tumor tissue block representative of glioblastoma available for biomarker analysis and determination of MGMT status (if not already done). If tumor block is not available or not of adequate quality, sufficient pathology material, representative of glioblastoma, must be available.* Adequate hematological function defined by absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 9 g/dL (may have been transfused).* Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and AST and ALT levels ≤ 2.5 × ULN for all subjects.* Adequate renal function defined by an estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method).* Negative serum pregnancy test at screening for women of childbearing potential.* Highly effective contraception for both male and female subjects if the risk of conception exists. (Note: The effects of the trial drug on the developing human fetus are unknown; thus, women of childbearing potential and men able to father a child must agree to use 2 highly effective contraception, defined as methods with a failure rate of less than 1 % per year. Highly effective contraception is required at least 28 days prior, throughout and for at least 60 days after avelumab treatment.* International normalized ratio (INR) or PT (secs) and activated partial thromboplastin time (aPTT):
* in the absence of therapeutic intent to anticoagulate the subject: INR≤1.5 or PT ≤1.5 x ULN and aPTT ≤1.5 x ULN
* in the presence of therapeutic intent to anticoagulate the subject: INR or PT and aPTT within therapeutic limits (according to the medical standard in the institution).
NOTE: Use of full-dose anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose of anticoagulants for at least two weeks prior to randomization.* Willing and able to comply with the protocol as judged by the Investigator
Exclusion Criteria:
* Patients who have evidence of leptomeningeal disease.* Known significant pulmonary, cardiovascular, hepatic disorders or any other disease that in the opinion of the investigator would be contraindicated to receive anti PD-L1 therapy such as avelumab.* Prior treatment with bevacizumab or any checkpoint immune blockade thérapies.* Any other concomitant immunosuppressant other than temozolamide and steroids or any recent (within 3 months) experimental therapy.* Patients who have finished their radiotherapy course more than 3 weeks prior to Baseline.* Prior organ transplantation, including allogeneic stem cell transplantation.* Significant acute or chronic infections including, among others:
* Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
* Positive test for HBV surface antigen and / or confirmatory HCV RNA (if anti-HCV antibody tested positive).* Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent:
* Subjects with diabetes type I, vitiligo, psoriasis, hypo or hyperthyroid disease or any other autoimmune disease not requiring immunosuppressive treatment are at the investigator's discretion eligible
* Subjects requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses ≤ 10 mg or 10 mg equivalent prednisone per day
* Administration of steroids through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) are acceptable.* Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI CTCAE v 4.03), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma).* Pregnancy or lactation.* Known alcohol or drug abuse.* Any psychiatric or cognitive condition that would prohibit the understanding or rendering of informed consent.* Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines.* Contraindication or intolerance to temozolomide.* Any other malignancy within 5 years prior to randomization, except for adequately controlled limited basal cell carcinoma of the skin, squamous carcinoma of the skin or carcinoma in situ of the cervix.* Evidence of any active infection requiring hospitalization or IV antibiotics within 2 weeks prior to randomization.* Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.* Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. | 17,228 |
Study Objectives
This phase II trial is studying how well vorinostat works in treating patients with relapsed or refractory indolent non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Conditions: Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, Nodal Marginal Zone Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma
Intervention / Treatment:
OTHER: Laboratory Biomarker Analysis, DRUG: Vorinostat
| Inclusion Criteria:
* Patients must have histologically or cytologically confirmed relapsed/refractory indolent Non-Hodgkin's lymphoma (Included in this category are relapsed/refractory follicular center lymphomas grade I, II, III, relapsed /refractory marginal zone B-cell lymphoma (nodal and extranodal), relapsed/refractory mantle cell lymphoma)
* Patients must have measurable disease by computed tomography (CT) scan. positron emission tomography (PET) scan evaluations are desirable but not mandatory, so that patients with negative PET scans but measurable disease by CT are eligible
* Patients may have had up to four prior chemotherapeutic regimens; steroids alone and local radiation do not count as regimens (radiotherapy must have been completed at least 14 days prior to starting SAHA); rituxan alone does not count as a regimen, however, Bexxar or Zevalin do; the most recent therapy must have failed to induce a complete response, or there must be disease progression or recurrence after the most recent therapy
* Patients may be enrolled who relapse after autologous stem cell transplant if they are at least three months after transplant, and after allogeneic transplant if they are at least six months post transplant; to be eligible after either type of transplant, patients must have achieved platelet counts greater than 100,000/mcL, and white blood cell (WBC) greater than 1,000/mcL at some point after their transplant, and should have no active related infections (i.e. fungal or viral); in the case of allogeneic transplant relapse, there should be no active acute graft versus host disease (GvHD) of any grade, and no chronic graft versus host disease other than mild skin, oral, or ocular GvHD not requiring systemic immunosuppression
* Life expectancy of greater than 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status #2 (Karnofsky >= 60%)
* Absolute neutrophil count >= 1,000/mcL
* Platelets >= 100,000/mcL
* Total bilirubin within normal institutional limits; patients with elevation of unconjugated bilirubin alone, as in Gilbert's Disease, are eligible
* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamate pyruvate \[SGPT\]) =< 2.5 x institutional upper limit of normal
* Creatinine up to and including 2 mg/dl
* Premenopausal women must have a negative serum pregnancy test prior to entry on this study; the effects of SAHA on the developing human fetus at the recommended therapeutic dose are unknown; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Patients who have had chemotherapy within 4 weeks, rituximab within three months (unless there is evidence of progression) or radiotherapy within 2 weeks or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier are excluded; this does not include use of steroids, which may continue until two days prior to enrollment; low dose chlorambucil should be stopped two weeks prior to beginning SAHA; valproic acid should be stopped at least two weeks prior to enrollment; nitrosoureas and mitomycin should be stopped 6 weeks prior to enrollment
* Patients may not be receiving any other investigational agents
* Patients with known brain metastases are excluded from this clinical trial unless the metastases are controlled after therapy and have not been treated with steroids within the past two months
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to SAHA
* There must be no plans for the patient to receive concurrent hormonal, biological or radiation therapy
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with SAHA
* Human immunodeficiency virus (HIV)-positive patients receiving combination antiretroviral therapy are ineligible
* Patients with other active malignancies are ineligible for this study | 15,518 |
Study Objectives
This study has a phase 1 and a phase 2 component.
In phase 1, the objective is to determine the maximum tolerated dose (MTD) of lenalidomide when after azacitidine.
In phase 2, the objective is to determine the efficacy of the combination treatment.
Conditions: Acute Myeloid Leukemia (AML), Adult Acute Myeloblastic Leukemia
Intervention / Treatment:
DRUG: Lenalidomide, DRUG: Azacitidine
| Inclusion Criteria
* WHO-confirmed acute myeloid leukemia (AML), except acute promyelocytic leukemia (APL)
* White blood cell count (WBC) at initiation of treatment ≤ 10,000
◦If WBC is > 10,000 patients may be started on an appropriate dose of hydroxyurea (to be determined by the investigators), until WBC < 10,000, at which time the hydroxyurea will be discontinued for 24 hours prior to enrollment
* Age ≥ 60 years and not a candidate for allogeneic stem cell transplantation
* Unwilling or unable to receive conventional chemotherapy
* No prior therapy, except supportive care measures such as growth factor support, blood product transfusions, apheresis, or hydroxyurea
* ECOG performance status ≤ 2
* Life expectancy > 2 months
* All study participants must be registered into the mandatory RevAssist® program, and must be willing and able to comply with the requirements of RevAssist
* If a female of childbearing potential (FCBP):
* Must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 to 14 days prior to study enrollment and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days)
* Must commit to either continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before starting lenalidomide.
* Must also agree to ongoing pregnancy testing.
* Male partners must use a latex condom during sexual contact, including if the male partners has previously had a successful vasectomy.
* Able to adhere to the study visit schedule and other protocol requirements
* Willing and able to understand and voluntarily sign a written informed consent
Exclusion Criteria
* Relapsed or refractory disease
* Prior therapy with lenalidomide
* History of intolerance to thalidomide or development of erythema nodosum while taking thalidomide or similar drugs
* Known or suspected hypersensitivity to azacitidine or mannitol
* Advanced malignant hepatic tumors
* Concomitant treatment with other anti-neoplastic agents, except hydroxyurea
* Anti-neoplastic treatment less than four weeks prior to enrollment, except hydroxyurea
* Use of any other experimental drug or therapy within 28 days of baseline
* Inability to swallow or absorb drug
* Active opportunistic infection or treatment for opportunistic infection within four weeks of first day of study drug dosing
* New York Heart Association Class III or IV heart failure
* Unstable angina pectoris
* Uncontrolled cardiac arrhythmia
* Uncontrolled psychiatric illness that would limit compliance with requirements
* Known HIV infection
* If female:
* Pregnant
* Breast-feeding females, if they do not agree to not breastfeed while taking lenalidomide
* Other medical or psychiatric illness or organ dysfunction or laboratory abnormality which in the opinion of the investigator would compromise the patient's safety or interfere with data interpretation
* Laboratory abnormalities:
* Creatinine ≥ 1.5 mg/dL
* Creatinine clearance ≤ 50 mL/min
* Total bilirubin > 1.5 x institutional upper limit of normal (ULN), except documented Gilbert's syndrome
* AST > 2.5 x institutional ULN
* ALT > 2.5 x institutional ULN | 423 |
Study Objectives
Observational study to evaluate, under real-world practice conditions, the safety and effectiveness of regorafenib in patients diagnosed with unresectable hepatocellular carcinoma (uHCC)
Conditions: Liver Neoplasms
Intervention / Treatment:
DRUG: Regorafenib (Stivarga, BAY73-4506)
| Inclusion Criteria:
* Patients with confirmed diagnosis of unresectable HCC
* Physician-initiated decision to treat with regorafenib (prior to study enrollment)
Exclusion Criteria:
* Participation in an investigational program with interventions outside of routine clinical practice
* Past treatment with regorafenib | 19,845 |
Study Objectives
This study tests biopsy and tissue from patients who have been treated for primary rectal cancer at the Royal Marsden Hospital between 2011 and 2013, who have an mrTRG score at post-chemoradiotherapy MRI. It is a retrospective pilot study to determine the apoptotic and proliferative index count pre and post chemoradiotherapy.
Conditions: Neoplasms, Colorectal Neoplasms, Rectal Diseases, Gastrointestinal Neoplasms
Intervention / Treatment:
| Inclusion Criteria:
* Patients over 18 years of age.
* Patients with primary adenocarcinoma of the rectum (diagnosed on tissue biopsy and disease spread assessed on CT and MRI).
* Tumours must be considered sufficiently high-risk to require pre-operative chemoradiotherapy followed by surgery.
* Patients must have had a pre- and post-treatment MRI scan of the rectum and pelvis.
* We must have access to stored tissue for each patient
Exclusion Criteria:
* No pre-operative radiotherapy
* Patients with synchronous tumours
* Patients under the age of 18 years | 2,104 |