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Study Objectives
Allogenic hematopoietic stem cell transplantation is a specific time during hematological disease management for the patients, theirs relatives and the healthcare team. This heavy treatment is most of the time the last possible curative therapy and could cause many side effects such as infectious diseases and graft versus host reaction. The protective isolation is also a source of physical and psychological isolation. Published studies reported depressive syndrome, anxiety symptoms and post-traumatic stress disorders for patients and their families. Since 10 years ago, diaries are used in intensive care unit to limit these symptoms after a coma. In analogy, the diary for the patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long terms consequences. The investigators want to evaluate the psychological impact of a diary on the patients hospitalized for allogenic hematopoetic stem cell transplantation and on their relatives.
Conditions: Hematopoietic/Lymphoid Cancer, Psychological Disorder
Intervention / Treatment:
BEHAVIORAL: quality of life questionnaire
| Inclusion Criteria:
* patient age > 18 years
* patient hospitalized for an hematopoietic allogenic stem cell transplantation
* patient agreeing to participate
Exclusion Criteria:
* patient not hospitalized for an hematopoietic allogenic stem cell transplantation | 31,341 |
Study Objectives
This trial is a multi-center, open-label, phase I, dose escalation study of PEP02 (liposomal encapsulated irinotecan) in combination with 5-FU and LV in patients with advanced solid tumors.
Conditions: Solid Tumor
Intervention / Treatment:
DRUG: PEP02, DRUG: 5-FU, DRUG: LV
| Inclusion Criteria:
* Histologically or cytologically confirmed solid tumor which was locally advanced or metastatic and had failed to standard chemotherapy or no standard treatment was available
* ECOG performance status 0 or 1
* With normal organ and marrow function
Exclusion Criteria:
* Have had major surgery, chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or have not recovered from toxicities due to previous treatment
* With known or suspicious primary or secondary brain tumors
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to PEP02, 5-FU or leucovorin
* HBsAg+ or anti-HCV+ patients with splenomegaly (defined as spleen size > 11 cm in CT scan)
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, and history of symptomatic congestive heart failure of Functional Class II or more (New York Heart Association) and ischemic heart diseases (i.e. myocardial infarction or angina pectoris), cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or breast feeding females (a pregnancy test must be performed on all females who are of child-bearing potential before entering the study and the result must be negative)
* Had received irinotecan treatment | 30,305 |
Study Objectives
To test the feasibility and accuracy of BioXmark fiducial markers for image guided radiotherapy (IGRT) based rectal tumor boosting in 20 patients referred for long course chemo-radiotherapy of the locally advanced rectal cancer.
Conditions: Rectal Cancer
Intervention / Treatment:
DEVICE: BioXmark liquid fiducial markers, OTHER: Imaging, PROCEDURE: surgery or wait-and-see
| Inclusion Criteria:
* Patients with histological or cytological proven adenocarcinoma of the rectum, treated with long course external beam radiotherapy
* Age > 18 years
* Have given written informed consent before patient registration
Exclusion Criteria:
* Patients using anticoagulants: platelet aggregation inhibitors or coumarines
* Iodine allergy | 23,657 |
Study Objectives
Current guidelines recommend withdrawal of treatments that affect the aldosterone/renin ratio (ARR) when screening for primary aldosteronism (PA). However, abandonment of mineralocorti-coid-receptor antagonist (MRA) and/or blockers of the renin-angiotensin system can deteriorate control of blood pressure (BP) and hypokalemia. Thus, in consecutive patients with an unambiguous diagnosis of PA in wash-out from confounding treatments and subtyped by AVS, the investigators have compared within-patient the plasma aldosterone and active renin concentration, and the ARR values, measured at baseline, and after a one-month treatment with MRA alone and combined with an AT-1 receptor blocker (ARB). Patients on a regular salt intake have been treated with canrenone (50-100 mg orally) for 1 month, after which olmesartan (10 or 20 mg orally) has been added for another month with up-titration of both treatments over the first 2 weeks to control BP and hypokalemia, however maintaining background therapy. The biochemical variables and the ARR have been assessed in an identical manner at baseline values and after each month of treatment. The investigators calculated that with a sample size of 40 patients the study will have a 95% power to show a clinically significant 20% change in the ARR at an 5% alfa-value using a two-sided paired t-test. Hence, this study will allow to determine if an MRA alone, or added to an ARB at doses that control BP and hypokalemia, affect or not the ARR, thus allow to establish if these agents can be administered or must be forbidden during the screening of PA.
Conditions: Primary Aldosteronism Due to Aldosterone Producing Adenoma
Intervention / Treatment:
DRUG: canrenone 50-100 mg orally once a day, DRUG: olmesartan 10-20 mg orally once a day
| Inclusion Criteria:
* age 18 - 75 years;
* diagnosis of Aldosterone Producing Adenoma (APA);
* written informed consent.
Exclusion Criteria:
* refusal to participate to the study;
* history of intolerance or allergy to canrenone or ARB. | 26,227 |
Study Objectives
Although highly curable, cervical cancer kills thousands of women in developing countries annually. The investigators will pilot a project to improve detection of cervical cancer in Kilimanjaro, Tanzania through a program that combines access to cervical screening expertise available in a large medical centre and remote use of a mobile phone camera application.
Conditions: Uterine Cervical Neoplasms, Cervical Cancer
Intervention / Treatment:
OTHER: Cervical cancer screening
| Inclusion Criteria:
* Female
* Over 18 years of age
Exclusion Criteria:
* Previous removal of uterus | 21,903 |
Study Objectives
The primary goal of this study is to evaluate the safety of a transcription factor decoy targeting Signal Transducer and Activator of Transcription 3(STAT3) in patients with head and neck cancer. The rationale for targeting STAT3 using this approach is to decrease STAT3-mediated gene regulation. The study has the following scientific objectives:
1. To assess the safety of a single dose of intratumoral STAT3 decoy.
2. To estimate the effect of STAT3 decoy therapy on STAT3 activation levels, STAT3-mediated gene expression, and apoptosis in treated tumors.
Conditions: Head and Neck Cancer
Intervention / Treatment:
DRUG: STAT 3 DECOY
| Inclusion Criteria:
* Histologically confirmed diagnosis of head and neck squamous cell carcinoma(primary or recurrent) amenable to surgical resection.
* ECOG performance status of 0, 1, or 2.
* Adequate organ function
* Age greater than or equal to 18 years
* Written informed consent.
* Patients with second primary lesions will be eligible for this trial.
* Negative pregnancy test, nonlactating, and using effective means of contraception if childbearing potential.
Exclusion Criteria:
* Subjects who fail to meet the above criteria.
* Subjects who are pregnant.
* Subjects with an ECOG performance status >2.
* Subjects with tumors that are too small to biopsy prior to resection and reserve a portion of the resected specimen for research purposes.
* Subjects who receive neoadjuvant radiotherapy and/or chemotherapy within four week prior to enrollment | 16,545 |
Study Objectives
The purpose of this study is to evaluate safety and tolerance of M2ES with TC regimen in advanced NSCLC.
Conditions: Non Small Cell Lung Cancer
Intervention / Treatment:
DRUG: M2ES
| Inclusion Criteria:
* Aged 18-70 years old;* Patients with Ⅲ/Ⅳ NSCLC confirmed by histopathology or cytology who ware naive or previous chemotherapy without TC regimen;* No contraindication for chemotherapy;* ECOG performance scale 0-2;* No history of anti-angiogenesis therapy;* Patients are voluntary to participate and sigh the informed contents.
Exclusion Criteria:
* Concurrent use of other anti-cancer agents;* Allergic history to M2ES and biological agents;* Pregnant or breast-feeding women;* With other malignancy;* With severe cardiopulmonary disease;* Uncontrolled brain metastasis patients;* Other conditions that are regarded for exclusion by the trialists. | 27,692 |
Study Objectives
The goal of this study is to learn if the study drug RAD001 can reduced the number of epileptic seizures, and can be taken safety by people who have epilepsy associated with Tuberous Sclerosis Complex.
Conditions: Epilepsy, Tuberous Sclerosis Complex
Intervention / Treatment:
DRUG: Everolimus
| Inclusion Criteria:
* Male or female individuals aged two years and older.
* History of epilepsy and at least eight reported seizures in previous 30 days prior to informed consent
* Failure of two or more approved antiepileptic drug therapies
* Clinically definite diagnosis of tuberous sclerosis (modified Gomez criteria or positive genetic test)
* Parents/Caregivers are English-speaking (primary or secondary language acceptable)
* If female and of child bearing potential, documentation of negative pregnancy test at time of informed consent. Sexually active pre-menopausal female or male patients must use adequate contraceptive measures, excluding use of estrogen-containing birth control contraceptive regimen while on study medication. Prior hysterectomy, tubal ligation, complete abstinence, barrier methods which include both a cervical diaphragm and spermicidal jelly, intrauterine devices (IUD), progesterone based contraceptives, or vasectomy in partner are all acceptable forms of contraception
* Adequate bone marrow function as shown by ANC ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L, and Hb >9 g/dL
* Adequate liver function as shown by serum bilirubin ≤ 1.5 x upper limit of normal (ULN), ALT and AST ≤ 2.5x ULN, INR and PTT ≤1.5. (Anticoagulation is allowed if target INR ≤ 1.5 on a stable dose of warfarin or on a stable dose of LMW heparin for >2 weeks at time of randomization.)
* Adequate renal function as shown by a serum 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
Exclusion Criteria:
* Significant hematological or hepatic abnormality (i.e., transaminase levels > 2.5 x ULN or serum bilirubin >1.5 x ULN, Hemoglobin < 9 g/dL, platelets < < 100 X 109/L , absolute neutrophil count < 1.5 x 109/L)
* Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, radiation therapy, antibody based therapy, etc.)
* Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study
* Prior treatment with any investigational drug within the preceding 4 weeks prior to informed consent
* Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed
* Patients should not receive immunization with attenuated live vaccines within one week of informed consent or during study period
* Patients with coexisting malignancies within past 3 years, except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
* Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
* Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
* Symptomatic congestive heart failure of New York heart Association Class III or IV, unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
* Severely impaired lung function defined as spirometry and DLCO that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air and/or requirement for continuous supplemental O2
* Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN
* Active (acute or chronic) or uncontrolled severe infections
* Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
* A known history of HIV seropositivity
* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
* Patients with an active, bleeding diathesis
* Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
* Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus).
* Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycin (sirolimus, temsirolimus) or to its excipients
* History of noncompliance to medical regimens | 26,545 |
Study Objectives
The purpose of the study was to determine the effect of Epoetin alfa therapy (short term versus long term) with and without a home-based individualized exercise program that incorporated aerobic and strength resistance training for patients being treated with high-dose chemotherapy and autologous peripheral bloodstem cell transplantation (PBSC T) for multiple myeloma. The endpoints for the study included the number of attempts at and total number of days of stem cell collection, number of RBC and platelet transfusions during the transplantation period, time-to-recovery after transplantation, and response to intensive therapy for multiple myeloma.
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: Epoetin Alfa, BEHAVIORAL: Exercise, BIOLOGICAL: Autologous Peripheral Blood Stem Cell Transplantation, BIOLOGICAL: Red Blood Cell Transfusion, DRUG: Thalidomide, DRUG: Heparin, Low-Molecular-Weight, BIOLOGICAL: Platelet Transfusion, DRUG: Melphalan, DRUG: Epoetin Alfa, DRUG: Total Therapy II, BIOLOGICAL: Red Blood Cell Transfusion, DRUG: Thalidomide, DRUG: Heparin, Low-Molecular-Weight, BIOLOGICAL: Platelet Transfusion, DRUG: Melphalan
| Inclusion Criteria:
* Those who were not at high risk for impending pathologic fracture or cord compression, as determined by magnetic resonance imaging and other radiology reports and physician assessments,and enrolled in Total Therapy treatment protocols were invited to participate in the study.
Exclusion Criteria:
Patients were excluded if they showed any of the following attributes/conditions:
* Inability to understand the intent of the study
* Current diagnosis with a major psychiatric illness
* Presence of microcytic or macrocytic anemia
* Uncontrolled hypertension
* Red cell transfusions within 2 weeks; and
* Recombinant epoetin alfa within 8 weeks of study enrollment. | 27,087 |
Study Objectives
To compare the feasibility, safety, and efficacy between single-port and four-port laparoscopic surgical staging in patients with early stage endometrial cancer.
Conditions: Endometrial Cancer
Intervention / Treatment:
PROCEDURE: single-port laparoscopic surgical staging, PROCEDURE: Four-port laparoscopic surgical staging
| Inclusion Criteria:
* Previously untreated, histologically confirmed endometrial cancer
* Presumed FIGO stage 1
* Endometrioid adenocarcinoma
* patient who is planned to undergo surgical staging
* adequate oran function
1. WBC > 3000 cells/mcl
2. Platelets > 100000/mcl
3. Creatinine < 2.0 mg/dL
4. Bilirubin < 1.5 \* normal and SGOT or SGPT < 3 \* normal
* American Society of Anesthesiologists Physical Status I-II
* Eastern Cooperative Oncology Group performance status 0-2
* Patients who have signed an approved Informed Consent
Exclusion Criteria:
* Uncontrolled medical disease
* Active infectious disease requiring antibiotics
* Previous pelvic radiation therapy
* Pregnant and lactating woman
* Patient who requires additional surgical procedures which are not necessary for surgical staging of endometrial cancer | 16,054 |
Study Objectives
This study is a retrospective study of clinical specimens. The study subjects were patients with esophageal cancer who received immunotherapy. Tumor tissue specimens surgically removed from patients before treatment will be collected primarily. In situ immunohistochemistry and multicolor immunofluorescence will be performed. We hypothesize that there are differences in lipid metabolism-related proteins in tumor tissues and immune cells in the preexisting tumor microenvironment in patients with esophageal cancer prior to immunotherapy, and that there is a link between such differences and the efficacy of immunotherapy.
Conditions: Esophageal Cancer
Intervention / Treatment:
OTHER: no intervention
| Inclusion Criteria:
* Esophageal cancer patients receiving immunotherapy* Radical esophagectomy for esophageal cancer at our institution prior to receiving immunotherapy* Age greater than or equal to 18 years and less than or equal to 75 years old Imaging to assess patient efficacy after cycle 2 immunotherapy (CR/PR, SD/PD according to recist 1.1)* Pathology Tumor tissue available
Exclusion Criteria:
* Clinical and pathologic information not available* Combined history of other malignant tumors* Unavailability of surgically resected tissue* Preoperative neoadjuvant therapy* Radical esophagectomy for esophageal cancer not performed prior to immunotherapy | 6,921 |
Study Objectives
The purpose of this research study is to find out what effects, good and/or bad, erlotinib has on the patient and their myelodysplastic syndrome. Erlotinib has been approved by the Food and Drug Administration (FDA) to treat non-small cell lung cancer; however, erlotinib use in this study is considered investigational as the FDA has not approved it for the treatment of myelodysplastic syndrome.
Conditions: Myelodysplastic Syndrome
Intervention / Treatment:
DRUG: Erlotinib
| Inclusion Criteria:
* Patients must have an established diagnosis of myelodysplastic syndrome (MDS) and have either: Low or intermediate 1 risk disease by International Prognostic Scoring System (IPSS) for MDS with symptomatic anemia (defined as hemoglobin less than 10.0 g/dl) or transfusion dependent anemia (defined as requiring ≥ 4 units of red blood cells (RBCs) administered with a pretreatment hemoglobin value of ≤ 9 g/dL in the 8 weeks prior to Day 1 of treatment in this study). Patients with anemia must have no response to at least to 6 weeks trial of erythroid stimulating agents (ESA) \[erythropoietin/ darbepoetin\]. Patients with serum erythropoietin levels more than 500 mU/ ml on diagnosis are eligible to the study without erythropoietin/darbepoetin prior treatment. Patients who do not meet anemia criteria are still eligible if they had thrombocytopenia with two or more platelet counts < 50 x 10\^9/L or a significant clinical hemorrhage requiring platelet transfusions or if they had neutropenia with an absolute neutrophil count (ANC) < 1 x 10\^9/L; Intermediate-2 or high risk MDS by IPSS.
* Patients ≥ 60 years with Acute Myeloid Leukemia (AML) by WHO classification and myeloblasts percentage 20-30% (RAEB-t by MDS French-American-British (FAB) classification) are eligible for the study if deemed not suitable for induction chemotherapy or declined that option.
* All prior treatment must have been discontinued 28 days prior to Day 1 of treatment in this study except (ESA) and colony stimulating factors where it should be stopped 14 days prior to start therapy on study, and hydroxyurea should be stopped 2 days before.
* Prior bone marrow or stem cell transplant is allowed.
* Secondary or therapy related MDS patients are eligible.
* Patients with chronic myelomonocytic leukemia (CMML) are eligible.
* Patients must have a performance status of 0 - 2 by Zubrod performance status criteria.
* Pretreatment pathology materials must be available for morphologic review. Collection of blood and marrow specimens for pathology review must be completed within 28 days prior to registration.
* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for at least 2 years.
* In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday four weeks later would be considered Day 28. This allows for efficient patient scheduling without exceeding the guidelines. If Day 28 or 60 falls on a weekend or holiday, the limit may be extended to the next working day.
* All patients must be informed of the investigational nature of this study and must sign and give written consent in accordance with institutional and federal guidelines.
Exclusion Criteria:
* Patients must not have received prior remission induction chemotherapy as treatment for MDS.
* Patients must not be pregnant or nursing because of the potential risks of the drugs used in this study. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
* Patients who are known HIV positive are not eligible for this study. | 25,250 |
Study Objectives
The purpose of this study is to determine the safety of EC1169 and the best dose to use in humans in future studies. This study will also determine how EC1169 is distributed, broken down, passed and absorbed through your body and how quickly it is eliminated (leaves the body). All patients will receive EC1169.
As a secondary objective in Part A: To explore the relationships between baseline PSMA expression (tumor and patient level) as measured by 99mTc-EC0652 scans and the antitumor activity of EC1169.
As an exploratory objective in Part B: To assess EC0652 as a predictive biomarker for the efficacy of EC1169 by comparing PSMA-positive and PSMA-negative lesions for response.
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: EC1169, OTHER: EC0652
| Inclusion Criteria:
* Patients must have the ability to sign an approved informed consent form (ICF).
* Patients must be ≥ 18 years of age.
* Patients must have histological, pathological and/or cytological confirmation of prostate cancer.
* Patients must have progressive, metastatic, castration-resistant prostate cancer (mCRPC) as defined below:
* Documented progressive metastatic CRPC will be based on at least one of the following criteria:
* PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2 ng/mL.
* Soft-tissue progression defined as an increase ≥ 20% in the sum of the longest diameter (LD) of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions.
* Progression of bone disease (evaluable disease) or (new bone lesion(s)) by bone scan.
* Patients must have prior and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (<50 ng/dL).
* Patients must have progressed on abiraterone and/or enzalutamide.
* Patients must have been previously treated with a taxane except in cases of contraindication (e.g. poor performance status, age or patient choice)
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Patients must have at least one measurable lesion that can be followed for response assessment on baseline imaging obtained no more than 28 days prior to beginning study therapy. Baseline and follow up radiological disease assessment must include bone scans performed with either Technetium-99m labeled diphosphonates or Fluorine-18 sodium fluoride PET or PET/CT, as per the local standard of care for patients with prostate cancer.
* Patients with CNS metastases that are symptomatic must have received therapy (surgery, XRT, gamma knife) and be neurologically stable and off of steroids. The patient should be off steroids at least 14 days before pre-registration. Asymptomatic CNS metastatic disease without associated edema, shift, requirement for steroids or anti-seizure medications are eligible after discussion with the sponsor medical monitor. For patients with a history of CNS metastasis, baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast)
* Patients must have recovered (to baseline/stabilization) from prior therapy-associated acute toxicities.
* Patients with prior radiation therapy are eligible if they meet the following criteria:
* Prior radiotherapy must be completed at least 4 weeks before patient begins study therapy.
* Patient must have recovered from the acute toxic effects of the treatment before beginning study therapy.
* Patients must have adequate organ function:
* Bone marrow reserve: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. Platelets ≥ 100 x 109/L. Hemoglobin ≥ 9 g/dL.
* Cardiac:
* Left ventricular ejection fraction (LVEF) equal to or greater than the institutional lower limit of normal. LVEF must be evaluated within 28 days prior to beginning study therapy.
* Cardiac Troponin I within normal limit.
* Hepatic: Total bilirubin ≤ 1.5 x the upper limit of normal (ULN). Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 3.0 x ULN OR ≤ 5.0 x ULN for patients with liver metastases.
* Renal: Serum creatinine ≤ 1.5 x ULN, or for patients with serum creatinine > 1.5 ULN, creatinine clearance ≥ 50 mL/min.
Exclusion Criteria:
* More than 3 prior systemic anti-cancer therapies (e.g. cytotoxic agents, biologic agents) regimens for metastatic disease
* Previous treatment with Samarium-153 or Strontium-89.
* Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy \[including monoclonal antibodies\]) within 28 days prior to beginning study therapy.
* Known hypersensitivity to the components of the study therapy or its analogs.
* Carcinomatous meningitis and/or symptomatic central nervous system (CNS) metastases.
* Malignancies that are expected to alter life expectancy or may interfere with disease assessment. Patients with adequately treated non-melanoma skin cancer and patients with prior history of malignancy who have been disease free for more than 3 years are eligible.
* Neuropathy CTCAE grade > 2
* QTc interval of > 480 ms.
* History of ischemic cardiac disease that has occurred within 6 months prior to study entry.
* Any other serious cardiac illness or medical conditions such as unstable angina, pulmonary embolism, or uncontrolled hypertension.
* Other concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy.
* Active uncontrolled infections
* Known active Hepatitis B or C infections
Inclusion Criteria for Part B:
To qualify for enrollment, the following criteria must be met:
* Patients must have the ability to understand, and have signed an approved ICF* Patients must be males ≥ 18 years of age* Patients must have histological, pathological and/or cytological confirmation of prostate cancer* Patients must have progressive mCRPC defined by meeting at least one of the following criteria:
1. PSA progression defined as 25% increase over a baseline value of > 2 ng/ml with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1-week interval. Baseline is defined as the PSA nadir level since commencing most recent prior therapy
2. Soft-tissue progression defined as an increase ≥ 20% in the sum of the diameter (SOD; short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD, or the appearance of one or more new lesions, since the onset of the most recent prior therapy
3. Progression of bone disease according to PCWG3 criteria* Patients must have a castrate level of serum testosterone (< 50 ng/dL)* For inclusion in Cohort 1, mCRPC patients must have progressed while receiving (or subsequent to receiving) abiraterone and/or enzalutamide but must not have previously received taxane-based systemic chemotherapy for mCRPC (previous treatment with six cycles of docetaxel for metastatic castration-sensitive prostate cancer (mCSPC) is permissible). NOTE: patients receiving fewer than 2 cycles of taxane based regimen due to intolerance are eligible for cohort 1.* For inclusion in Cohort 2, mCRPC patients must have progressed while receiving (or subsequent to receiving) abiraterone and/or enzalutamide and must have progressed subsequent to receiving ≥ 2 cycles of a taxane-based regimen for mCRPC.* Patients must have a ECOG performance status of 0 or 1* Patients must have at least one metastatic lesion that can be followed on baseline imaging obtained no more than 28 days prior to beginning study therapy. Baseline and follow up radiological disease assessments must include bone scans performed with 99mTc labelled diphosphonates* Patients with a history of CNS metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast)* Patients must have recovered (to baseline/stabilization) from prior chemo- or radio-therapy and associated acute toxicities must have resolved to a NCI CTCAE v4 Grade 1 or less, with the exception of alopecia* Patients must have adequate organ function:
a) Bone marrow reserve: ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, hemoglobin ≥ 9 g/dL b) Cardiac: i) QTcF < 450 msec on at least 2 of 3 screening ECGs. On site determination of QTcF may be used for screening purposes ii) LVEF equal to or greater than the institutional lower limit of normal. LVEF must be evaluated within 7 to 10 days prior to beginning study therapy iii) Cardiac Troponin I within normal limit (as per local institution) c) Hepatic: Total bilirubin ≤ 1.5 x ULN, ALT, AST ≤ 3.0 x ULN OR ≤ 5.0 x ULN for patients with liver metastases d) Renal: Serum/plasma creatinine ≤ 1.5 x ULN, or for patients with serum/plasma creatinine > 1.5 ULN, creatinine clearance ≥ 50 mL/min
Exclusion Criteria for Part B:
The presence of any of the following will exclude the patient from the study:
* Previous treatment with Samarium-153, Strontium-89, Rhenium-186 or Radium-223 within 6 months of starting (i.e., Cycle 1 Day 1) EC1169* Any systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy or biological therapy (including monoclonal antibodies), or experimental anti-cancer therapy) within 28 days prior to beginning study therapy. Note: Ongoing castrating therapy with a GnRH agonist or antagonist is mandatory to assure a castrate level of serum testosterone <50 ng/dL, except in patients who have undergone an orchiectomy. Bisphosphonates or denosumab continuation is permissible (i.e., no change for 30 days prior to Cycle 1 Day 1). Patients who receive a dose of EC1169 under another Endocyte protocol do not need a washout period for EC1169* Known hypersensitivity to the components of the study therapy. (Please reference Section 1, Formulation of EC1169 and EC0652, in the respective Pharmacy Manuals)* Carcinomatous meningitis and/or symptomatic CNS metastases* Concurrent malignancies that are expected to alter life expectancy (e.g., NSCLC, etc.) or that may interfere with assessment of prostate cancer (e.g., lymphoma involving the periaortic nodes). Patients with adequately treated non-melanoma skin cancer or non-muscle invasive urothelial carcinoma, and patients with prior history of malignancy who have been disease-free for more than 5 years are eligible* Patients considered at risk for life-threatening QTc prolongation (i.e., personal or family history of Long QT syndrome, presence of implantable pacemaker, or implantable cardioverter defibrillator, etc.)* Use of the following medications within 6 months prior to EC1169 administration: amiodarone, disopyramide, dofetilide, dronedarone, flecanamide, ibutilide, quinidine, or sotalol* Any other serious cardiac illness or medical conditions such as unstable angina, pulmonary embolism, or uncontrolled hypertension* Known systemic infections including, but not limited to hepatitis B or C, or HIV | 37,250 |
Study Objectives
This prospective hybrid longitudinal study was conducted in the United States (US), Canada, the United Kingdom (UK), and Germany. To obtain the most complete and comprehensive understanding of the burden of opioid-induced constipation (OIC) in these countries, this study used a combination of web-based, longitudinal patient survey, retrospective data abstraction from medical records, and a prospective physician survey.
The primary objective of this study was to estimate the rate of inadequate response to laxatives (LIR), which was defined as having sufficient laxative use (at least one laxative use ≥ four times per reference period), and inadequate response (defined as fewer than three bowel movements (BMs) OR at least one of the following symptoms on the Patient Assessment of Constipation Symptoms (PAC-SYM) measure scored as moderate, severe or very severe: BMs too hard, straining to have a BM, feeling like you didn't "finish" a BM, and feeling like you had to pass a BM but could not), in a cohort of non-cancer pain and cancer pain (separately) participants with OIC, by country and overall.
The secondary study objectives are as follows:
1. To estimate the rate of LIR for two subgroups: 1xLIR and 2xLIR. 1xLIR was defined as use of at least one laxative agent ≥ 4 times in the reference period while 2xLIR was defined as the use of at least two laxative agents, each used ≥ 4 times in the reference period;
2. To describe the baseline demographic and clinical characteristics, including prior health status, comorbidities, constipation-related GI symptoms, and concomitant medications of patients with OIC;
3. To describe drug utilization and self-management of OIC;
4. To describe the pre-index and post-index healthcare resource utilization and estimate costs associated with the diagnosis, treatment, and general management of OIC (including laxative use) and events attributed to OIC, including both direct and indirect costs;
5. To describe patient-reported impact of OIC on health-related quality of life, productivity, and pain management;
6. To describe patient-reported treatment satisfaction with laxative use; and
7. To describe physician-reported awareness of OIC and symptoms and understanding of patient-reported impact of OIC.
Conditions: Patients With Opioid Induced Constipation
Intervention / Treatment:
| Inclusion Criteria:
* Patient is receiving a minimum total daily dose of 30 mg of oral morphine, or equianalgesic amount\[s\] of 1 or more other opioid therapies, for a minimum of 4 weeks for chronic pain or cancer relate pain Presence of OIC in the past 2 weeks
* (for cancer patients only) Patient has a current diagnosis of cancer that is not currently in remission and has cancer-related pain Internet access and is able and willing to complete a longitudinal web-based survey
* Patient is able to understand and comply with the requirements of the study, as judged by the investigator (includes ability to read and write and to use
Exclusion Criteria:
* Patient is unable or refuses to provide informed consent;
* Patient does not have access to a computer with internet connectivity, or is unable to use a computer to complete the web-based survey; Based on clinical judgment, patient has a history of chronic constipation (i.e. clinical diagnosis, note in the medical record, or patient history);
* Patient has a history of (or current) colon cancer (primary or metastatic) (i.e., clinical diagnosis Patient has received an investigational medication to treat constipation or participated in any study involving investigational compound naloxegol within ≤90 days prior to the baseline visit | 37,746 |
Study Objectives
The purpouse of the study is to determine wether Ultrasound Guided,Ens-assisted paravertebral block with single shot is a safe and reliable anesthetic technique in breast surgery.
Conditions: Breast Cancer
Intervention / Treatment:
| Inclusion Criteria:
* American Society of Anesthesiologists classification I-III
* Written informed consent
* Age older than 18 years old
Exclusion Criteria:
* allergy to local anesthetics
* local sepsis | 20,071 |
Study Objectives
The purpose of this study is to ask youn women diagnosed with ovarian cancer who have undergone surgery that will allow them to have children in the future, on issues such as: education about their options to keep their ability to have children, after-chemotherapy treatment decision making, and reproductive history. The second purpose is to determine the effect of an early diagnosis of ovarian cancer on the sexual functioning of women.
Conditions: Ovarian Cancer
Intervention / Treatment:
BEHAVIORAL: Fertility-Sparing Survey
| Inclusion Criteria:
* Women diagnosed with stage I or II invasive ovarian cancer, that underwent fertility sparing surgery
* Women who were premenopausal prior to diagnosis
* 40 years of age or younger at the time of ovarian cancer diagnosis
* Completed therapy for early stage cancer
* No evidence of recurrence
* No history fo known infertility prior to diagnosis
* No other significant medical conditions that would affect fertility | 1,570 |
Study Objectives
The purpose of this study is to compare outcomes of patients undergoing standard or extended lymphadenectomy in pancreaticoduodenectomy for pancreatic cancer
Conditions: Pancreatic Ductal Adenocarcinoma
Intervention / Treatment:
PROCEDURE: Pancreaticoduodenectomy with Standard lymphadenectomy, PROCEDURE: Pancreaticoduodenectomy with Extended lymphadenectomy
| Inclusion Criteria:
* Pathologic diagnosis of pancreatic ductal adenocarcinoma
* Signed the informed consents
Exclusion Criteria:
* Pathologic diagnosis of other pancreatic cancers
* Pre-operative anti-cancer treatment
* Recurrence patients
* Patients with contraindication(hepatic/ respiratory/ renal dysfunction, etc )
* Pre operative exam: Total bilirubin more than 250µmol/L
* AJCC stage IV
* Operation non radical | 21,176 |
Study Objectives
The goal of this clinical trial is to determine if low single palliative dose radiation to the lung cancer will improve your immune response against the tumor and if sequential treatment with pembrolizumab (the study drug) would offer superior results compared to pembrolizumab alone in participants with non-small cell lung cancer.
The purpose of this research is also to study whether there are any changes present in the DNA, RNA, and proteins of a participant's tumor or the blood cells that may contribute to a response to the study treatment or progression of cancer. This research may help researchers in the future to learn more about the causes, risks, treatments, or prevention of cancers or other health problems.
Participants will consent to a screening period, a core or treatment phase, and a post-study observation phase. During the screening phase, participants will undergo a series of tests to determine if they are eligible for the study. The core study period, or treatment period, will start with a single dose of radiation and then continue for the first eight treatments of pembrolizumab, approximately 24-28 weeks. Participants will have a new biopsy taken after two treatments of the study drug. Following the 24-28 week treatment cycle, if the cancer is responding to treatment, the participant's physician will continue to treat with pembrolizumab as a standard treatment. Following treatment, the post-study observation phase will monitor participant response to drugs and outcomes.
Conditions: Stage IV Non-Small Cell Lung Cancer
Intervention / Treatment:
DRUG: Pembrolizumab, RADIATION: Single Fraction Radiation Therapy
| Inclusion Criteria:
* Be willing and able to provide written informed consent/assent for the trial.
* Have measurable disease based on RECIST 1.1.
* Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor and primary investigator.
* Have a performance status of ≤1 ECOG Performance Scale.
* Demonstrate adequate organ function
* Absolute neutrophil count (ANC) ≥ 1,500/mcL
* Platelets ≥ 100,000/mcL
* Hemoglobin ≥ 9g/dL
* Serum creatinine or measured ≤1.5 times the upper limit of normal (ULN) or measured or calculated creatinine clearance ≥ 60 mL/min for subjects with creatinine levels >1.5 times the institutional ULN
* Serum total bilirubin ≤ 1.5 X ULN or direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN
* AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN or ≤ 5 times ULN for subjects with liver metastases
* Albumin ≥ 2.5 mg/dL
* Have one measurable lesion of at least 1 cm outside the planned radiation field (defined as not receiving direct beam from any of the treatment portals).
* Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
* Female subjects of childbearing potential must be willing to use an adequate method of contraception - Contraception, for the course of the study through 120 days after the last dose of study medication.
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
* Male subjects of childbearing potential must agree to use an adequate method of contraception- Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Exclusion Criteria:
* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
* Has a known history of active TB (Bacillus Tuberculosis)
* Hypersensitivity to pembrolizumab or any of its excipients.
* Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
* Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
* Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
* Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
* Patient who have previously received radiation overlapping with the current planned radiation treatment fields are ineligible. Overlap is defined as any tissue falling within the direct path of both prior and current planned radiation fields.
* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
* Patients with active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks and, have no evidence of new or enlarging brain metastases and also are off steroids 3 days prior to dosing with study medication. Stable brain metastases by this definition should be established prior to the first dose of pembrolizumab.
* Has had prior chemotherapy, within 2 weeks prior to study treatment. Patients on targeted therapy (tyrosine kinase inhibitor) may go on the study after 5 days off therapy.
* Patients who have not recovered (i.e., ≤ Grade 2 or at baseline) from adverse events due to a previously administered agent.
--Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
* Has history of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis.
* Has an active infection requiring systemic therapy.
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
* Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
* Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C.
* Has received a live vaccine within 30 days of planned start of study therapy.
* Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed. | 33,446 |
Study Objectives
This proposed study aims to examine the effect of classical aerobic exercise or tai-chi on 1-year survival rate of lung cancer patients compared to usual care, as a primary outcome of this study. To understand the hypothesized outcomes of improved survival of lung cancer patients through physical exercise or tai-chi practice intervention, we will examine the changes in some subjective psychosocial outcomes and objective biomarkers that may be associated with the survival of cancer patients, as the secondary outcome of this study. Those biomarkers will be in following aspects: 1.) circadian rhythm, 2.) cardio-respiratory fitness, and 3.) immune functions. Secondary outcome measures include: quality of life, psychological distress, quality of sleep, fatigue, level of physical activity, circadian rhythms, cardio-respiratory fitness, physical functioning tests and immune function. The pilot study aims to assess the feasibility and acceptability of the trial so that the main study will have a higher chance of success.
Conditions: Lung Cancer Patients
Intervention / Treatment:
BEHAVIORAL: Exercise, BEHAVIORAL: Tai-Chi
| Inclusion Criteria:
* Patients who are diagnosed of stage IIIB, or IV non-small-cell lung cancer confirmed by pathology* Patients are not currently engaged in other research or participant in any other exercise or mind-body classes* Patients aged 18 years old, or above* Patients who can communicate in Cantonese, Mandarin or English* Patients with no other cancer diagnosis within the previous 1 year* Patients report not doing regular exercises (defined <150 min of moderate-intensity exercise weekly) in daily living, but are able to attend either exercise or tai-chi classes at scheduled times* Patients being conscious and alert.
Exclusion Criteria:
Patients suffering from a diagnosed active neurological, substance abuse and /or psychiatric disorders (i.e. depression, chronic insomnia) will be excluded. | 10,859 |
Study Objectives
Study Title: A Pilot Randomized Controlled Trial of the Promoting Resilience in Stress Management (PRISM) Intervention for Adolescents and Young Adults with Cancer
Study Population and Sample Size: Two cohorts of Adolescent and Young Adult (AYA) patients with diagnosis of new or recurrent cancer between 1 and 10 weeks prior to enrollment: those ages 13-17 (N=50); (2) those ages 18-25 (N=50).
Study Design: Pilot randomized controlled trial (RCT).
Primary Objective: To test the efficacy of the "Promoting Resilience in Stress Management" (PRISM) among Adolescents and Young Adults with cancer.
Primary Outcome: Change in patient-reported resilience (based on score of standardized Connor-Davidson Resilience Scale) at 6 months.
Secondary Outcomes:
1. Patient-reported resilience at 2, 4, and 12 months
2. Patient-reported self-efficacy, benefit-finding, psychological distress, quality of life, and health-behaviors at 6 and 12 months.
3. Qualitative assessment of patient-reported goals at 6 and 12 months
4. Development of a cohort of AYA cancer survivors for assessment of long-term psychosocial outcomes
Study Duration: 3 years
Conditions: Cancer, Acute Lymphoblastic Leukemia, Lymphoma, Sarcoma, Acute Myelogenous Leukemia, Brain Tumors, Germ Cell Tumor
Intervention / Treatment:
BEHAVIORAL: Promoting Resilience In Stress Management (PRISM)
| Inclusion Criteria:
* Age 13-25 years
1. Patient aged 13-17 years: has signed informed assent and their parent/legal guardian has signed informed consent for study participation.
2. Patient aged 18-25 years: has signed informed consent for study participation.* Diagnosis of malignancy treated with chemotherapy and/or radiation therapy at Seattle Childrens Hospital (SCH)
1. New diagnosis of malignancy within 1-10 weeks of enrollment
2. New diagnosis of recurrent disease (after initial remission) within 1-10 weeks of enrollment* Ability to speak and read English language* Cognitively able to participate in interactive interviews
Exclusion Criteria:
* Patient refusal to participate (any age), or parental refusal to participate for patients less than 18 years of age* Cognitively or physically unable to participate in interactive interview* Unable to speak and read English language* Patient without chemotherapy and/or radiation therapy as part of cancer treatment (e.g., surgical resection only patients are not-eligible). | 8,543 |
Study Objectives
To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus sham procedure
Conditions: Hot Flash, Stellate Ganglion Block, Postmenopausal, Hot Flushes
Intervention / Treatment:
PROCEDURE: Bupivacaine block, PROCEDURE: Placebo ganglion block
| Inclusion Criteria:
* Female
* Age: 30-70 years
* Mean daily flush frequency of 10 or more and a hot flush score of 15 or more
* Absence of any non-menopausal cause of flushing
* Post-menopause amenorrhea for more than 1 year in healthy postmenopausal women
* In case of breast cancer or ovariectomy induced menopause: ovariectomy for > 6 months. Adjuvant therapy with estrogen-receptor blocker or an aromatase inhibitor.
Exclusion Criteria:
* Use of medication that affects flushing:oestrogens, progestogens, clonidine, naloxone, paroxetine, fluoxetine, venlafaxine, gabapentin, luteïniserend hormone releasing hormones receptor antagonist
* Receiving chemotherapy of radiotherapy
* Active psychiatric disease
* Active concurrent disease
* Allergic reactions against local anesthetics of the 'amide' type or contrast media. | 4,665 |
Study Objectives
Patients are recruited at diagnosis or at relapse of ATLL-HR in French Caribbean islands and Guyana. They all receive Zidovudine and Pegylated Interferon (ZPI). For patients younger than 65 years old, an allogeneic donor is searching out. Patients included at relapse and with lymphoma clinico-biological subtype also receive chemotherapy (CT). Responses are assessed during ZPI+/-CT and eligible patients (depending on age, comorbidities and response criteria) receive allogeneic transplant. Patient follow-up is planned for 3 years old
Conditions: T-cell Lymphoma, Leukaemia
Intervention / Treatment:
| Inclusion Criteria:
* Patient >18 years old and ≤ 75 years old, with ATLL-HR who signed informed consent.
Exclusion Criteria:
* Pregnant or nursing women are not eligible; neither are women of childbearing potential unless using effective contraception as determined by the patient's physician. | 2,195 |
Study Objectives
* This randomized controlled three arm study compares the effects of a yoga intervention with jacobsons progressive muscle relaxation training and only standard of care in chemotherapy naive cancer patients.
* This study will also assess the neurophysiological correlates of nausea and vomiting and assess if effects of intervention on nausea and vomiting outcomes are mediated by changes in gastric motility (electrogastrogram) or stress arousal (cardiac autonomic function and sympathetic skin response) or self reported anxiety.
Conditions: Breast Cancer, Malignant Female Reproductive System Neoplasm, Lymphomas, Chemotherapy-induced Nausea and Vomiting
Intervention / Treatment:
BEHAVIORAL: yoga, BEHAVIORAL: Jacobsons PMRT group
| Inclusion Criteria:
* Patients with gynecologic malignancies (breast, ovary) and Lymphomas.
* Age between 30-70 years.
* Chemotherapy naïve.
* High school education.
Exclusion Criteria:
* Those with brain metastases
* Concurring medical condition likely to influence survival
* Uncontrolled diabetes and hypertension
* GI metastases, peritoneal fluid, uraemia
* Neurological disorders such as Parkinson's disease, myotonic dystrophy etc.
* GI obstruction and past H/o abdominal surgeries.
* Cognitive impairments.
* Regular participation in a behavioral intervention/yoga in the last six months | 98 |
Study Objectives
This phase II trial studies the side effects and the best dose of alemtuzumab when given together with fludarabine phosphate and low-dose total body irradiation (TBI) and how well it works before donor stem cell transplant in treating patients with hematological malignancies. Giving chemotherapy and low-dose TBI before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine (CSP) and mycophenolate mofetil (MMF) after transplant may stop this from happening.
Conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Childhood Burkitt Lymphoma, Childhood Chronic Myelogenous Leukemia, Childhood Diffuse Large Cell Lymphoma, Childhood Immunoblastic Large Cell Lymphoma, Childhood Nasal Type Extranodal NK/T-cell Lymphoma, Chronic Phase Chronic Myelogenous Leukemia, Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma, Contiguous Stage II Grade 1 Follicular Lymphoma, Contiguous Stage II Grade 2 Follicular Lymphoma, Contiguous Stage II Marginal Zone Lymphoma, Contiguous Stage II Small Lymphocytic Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hepatosplenic T-cell Lymphoma, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Nodal Marginal Zone B-cell Lymphoma, Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma, Noncontiguous Stage II Grade 1 Follicular Lymphoma, Noncontiguous Stage II Grade 2 Follicular Lymphoma, Noncontiguous Stage II Marginal Zone Lymphoma, Noncontiguous Stage II Small Lymphocytic Lymphoma, Peripheral T-cell Lymphoma, Previously Treated Myelodysplastic Syndromes, Progressive Hairy Cell Leukemia, Initial Treatment, Recurrent Adult Acute Myeloid Leukemia, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Anaplastic Large Cell Lymphoma, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Recurrent/Refractory Childhood Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Hairy Cell Leukemia, Refractory Multiple Myeloma, Relapsing Chronic Myelogenous Leukemia, Splenic Marginal Zone Lymphoma, Stage I Adult Diffuse Small Cleaved Cell Lymphoma, Stage I Childhood Anaplastic Large Cell Lymphoma, Stage I Childhood Large Cell Lymphoma, Stage I Cutaneous T-cell Non-Hodgkin Lymphoma, Stage I Grade 1 Follicular Lymphoma, Stage I Grade 2 Follicular Lymphoma, Stage I Mantle Cell Lymphoma, Stage I Marginal Zone Lymphoma, Stage I Mycosis Fungoides/Sezary Syndrome, Stage I Small Lymphocytic Lymphoma, Stage II Childhood Anaplastic Large Cell Lymphoma, Stage II Childhood Large Cell Lymphoma, Stage II Cutaneous T-cell Non-Hodgkin Lymphoma, Stage II Mycosis Fungoides/Sezary Syndrome, Stage III Adult Diffuse Large Cell Lymphoma, Stage III Adult Diffuse Small Cleaved Cell Lymphoma, Stage III Childhood Anaplastic Large Cell Lymphoma, Stage III Childhood Large Cell Lymphoma, Stage III Cutaneous T-cell Non-Hodgkin Lymphoma, Stage III Grade 1 Follicular Lymphoma, Stage III Grade 2 Follicular Lymphoma, Stage III Mantle Cell Lymphoma, Stage III Marginal Zone Lymphoma, Stage III Mycosis Fungoides/Sezary Syndrome, Stage III Small Lymphocytic Lymphoma, Stage IV Adult Diffuse Large Cell Lymphoma, Stage IV Adult Diffuse Small Cleaved Cell Lymphoma, Stage IV Childhood Anaplastic Large Cell Lymphoma, Stage IV Childhood Large Cell Lymphoma, Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma, Stage IV Grade 1 Follicular Lymphoma, Stage IV Grade 2 Follicular Lymphoma, Stage IV Mantle Cell Lymphoma, Stage IV Marginal Zone Lymphoma, Stage IV Mycosis Fungoides/Sezary Syndrome, Stage IV Small Lymphocytic Lymphoma, T-cell Large Granular Lymphocyte Leukemia, Waldenström Macroglobulinemia
Intervention / Treatment:
BIOLOGICAL: alemtuzumab, DRUG: fludarabine phosphate, RADIATION: total-body irradiation, PROCEDURE: allogeneic hematopoietic stem cell transplantation, PROCEDURE: peripheral blood stem cell transplantation, DRUG: mycophenolate mofetil, DRUG: cyclosporine
| Inclusion Criteria:
* Patients must be not eligible for conventional transplants and must have disease expected to be stable for at least 100 days without chemotherapy; patients with hematologic malignancies treatable with hematopoietic stem cell transplant (HSCT) or with a B cell malignancy except those treatable with autologous transplant will be included
* Aggressive non-Hodgkin lymphomas (NHLs) and Other Histologies Such as Diffuse large B cell NHL
* Patients with primary refractory or relapsed disease not eligible for an autologous transplant
* Patients are eligible following an autologous transplant in remission or in relapse
* Planned tandem transplant is allowed for patients at high risk of relapse
* Low grade NHL with < 6 months duration of complete remission (CR) between courses of conventional therapy
* Mantle Cell NHL may be treated in first CR
* Chronic lymphocytic leukemia (CLL) - Must have failed 2 lines of conventional therapy and be refractory to fludarabine
* Hodgkin disease (HD) - Must have received and failed frontline therapy; patients must have had a prior autologous transplant or were not eligible for autologous transplant; planned tandem transplants are allowed for patients at high risk of relapse
* Multiple myeloma (MM) - Must have received prior chemotherapy and a prior autologous transplant, unless autologous transplant was not possible; planned tandem transplants are allowed for patients at high risk of relapse
* Acute myeloid leukemia (AML) - Must have < 5% marrow blasts at the time of transplant
* Acute lymphocytic leukemia (ALL) - Must have < 5% blasts at the time of transplant
* Chronic myeloid leukemia (CML) - Patients will be accepted beyond chronic phase 1 (CP1) if they have received previous myelosuppressive chemotherapy or HSCT, and have < 5% marrow blasts at time of transplant
* Myelodysplastic (MDS)/Myeloproliferative disorders - Must have failed previous myelosuppressive chemotherapy or HSCT, and have < 5% marrow blasts at time of transplant
* Waldenstrom's Macroglobulinemia - Must have failed 2 courses of therapy
* Patients < 12 years old must be approved by the Fred Hutchinson Cancer Research Center (FHCRC) principal investigator (PI)
* Patients who refuse to be treated on a conventional transplant protocol; for this inclusion, criteria transplants must be approved by both the participating institution´s patient review committee such as the Patient Care Conference (PCC) at the FHCRC and the FHCRC principal investigator
* Patients with related or unrelated donors for whom
* The best available match is a HLA class II DRB1 and DQB1 matched donor incompatible for any single serologically detectable class I HLA-A, -B, -C mismatch; one additional allele level class I mismatch is allowed OR any combination of 2 allele level mismatches (if typed at the molecular level)
* There is a likelihood of rapid disease progression while HLA typing and results of a preliminary search and the donor pool suggests that a 10/10 HLA-A, B, C, DRB1 and DQB1 matched unrelated donor will not be found
* There is no HLA-A, -B or -C one locus allelic mismatched related donor available
* There is no indication for an autologous transplantation as a treatment option
* DONOR: Related or unrelated donors who are matched for HLA-DRB1 and DQB1 alleles (must be defined by high resolution typing), and who are mismatched for:
* Any single serologically detectable HLA-A or B or C antigen +/- 1 allele or
* Any combination of two HLA-A, -B, or -C alleles (if prospectively typed at molecular level)
Exclusion Criteria:
* Patients who are homozygous at the mismatched major histocompatibility complex (MHC) class I locus
* A positive cross-match exists between the donor and recipient
* Patients with rapidly progressive intermediate or high grade NHL
* Presence of circulating leukemic blasts (in the peripheral blood) detected by standard pathology for patients with AML, ALL or CML
* Life expectancy severely limited by diseases other than malignancy
* Central nervous system (CNS) involvement with disease refractory to intrathecal chemotherapy
* Fertile men or women unwilling to use contraceptives during and for up to 12 months post treatment
* Female patients who are pregnant or breast-feeding
* Human immunodeficiency virus (HIV) positive patients
* Patients with active non-hematologic malignancies (except non-melanoma skin cancers)
* Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a > 20% risk of disease recurrence
* Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than 1 month
* Patients with active bacterial or fungal infections unresponsive to medical therapy
* Patients with the following organ dysfunction symptomatic coronary artery disease or ejection fraction < 35% or other cardiac failure requiring therapy; ejection fraction is required if the patient is > 50 years of age, or history of cardiac disease or anthracycline exposure
* Diffusion capacity of carbon monoxide (DLCO) < 35%; total lung capacity (TLC) < 35%; or forced expiratory volume in one second (FEV1) < 35% and/or receiving supplementary continuous oxygen
* Patients with clinical or laboratory evidence of liver disease would be evaluated for the cause of liver disease, its clinical severity in terms of liver function, bridging fibrosis, and the degree of portal hypertension; patients will be excluded if they are found to have fulminant liver failure; cirrhosis of the liver with evidence of portal hypertension; alcoholic hepatitis; esophageal varices; a history of bleeding esophageal varices; hepatic encephalopathy; uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time; ascites related to portal hypertension; bacterial or fungal liver abscess; biliary obstruction; chronic viral hepatitis with total serum bilirubin >3 mg/dL; or symptomatic biliary disease
* Patients with poorly controlled hypertension on multiple antihypertensives
* Karnofsky score < 70 for adult patients
* Lansky-Play Performance Score < 50 for pediatric patients
* DONOR: Bone marrow (BM) donors
* DONOR: Donors who are HIV-positive and/or, medical conditions that would result in increased risk for granulocyte colony-stimulating factor (G-CSF) mobilization and harvest of peripheral blood stem cell (PBSC)
* DONOR: Donors < 12 years of age | 3,746 |
Study Objectives
This is a Phase I/IIa study to evaluate safety and efficacy of dalotuzumab (MK-0646) in combination with erlotinib in participants with recurrent Non-Small Cell Lung Cancer (NSCLC). The Phase I part of this study will determine the highest tolerated dose of dalotuzumab to be given in combination with erlotinib. The primary hypothesis for the Phase I part of the study is that administration of erlotinib in combination with dalotuzumab in participants with recurrent NSCLC is generally well-tolerated as evidenced by accumulated safety data from this trial. The Phase II part of this study will investigate how well dalotuzumab works in conjunction with erlotinib at treating recurrent NSCLC. The primary hypothesis for the Phase II part of this study is that administration of erlotinib in combination with dalotuzumab in participants with recurrent NSCLC results in improvement in Progression Free Survival (PFS) compared to participants treated with erlotinib alone. PFS is defined as the time from randomization until either the emergence of radiographic evidence of disease progression (as documented by an independent core laboratory) or death due to any cause, whichever occurs first.
Conditions: Carcinoma, Non-small-cell Lung
Intervention / Treatment:
DRUG: Dalotuzumab, DRUG: Erlotinib
| Inclusion Criteria:
* Participant has locally advanced or metastatic stage IIIB/IV NSCLC that has relapsed after hemotherapy/chemoratiotherapy
* Participant has had at least one chemotherapy regimen for recurrent or metastatic disease
* Participant is 18 years of age or older
* Participant has a performance status of 0-2 on Eastern Cooperative Group (ECOG) scale
* Women of childbearing potential have a negative pregnancy test
Exclusion Criteria:
* Participant has had chemotherapy within 2 weeks or biological therapy (e.g. bevacizumab) within 4 weeks
* Participant has not recovered from adverse events from previous therapy within 4 weeks
* Participant has received EGFR-Tyrosine Kinase Inhibitor (TKI) inhibitor/anti-EGFR mAb therapy
* Participant has received IGF1R-TKI inhibitor/anti-IGF1R mAB therapy
* Participant has had more than 2 systemic chemotherapies for metastatic disease
* Participant has not completed radiotherapy with complete resolution of toxicities at least 2 weeks before starting in the study
* Participant is taking part in another clinical study
* Participant has a primary central nervous system tumor
* Participant abuses drugs or alcohol
* Participant is pregnant or breastfeeding
* Participant is Human Immunodeficiency Virus (HIV) positive
* Participant has a history of hepatitis B or C
* Participant is using growth hormone or growth hormone inhibitors | 19,794 |
Study Objectives
Gestational trophoblastic neoplasias (GTN) are characterized by the persistence of elevated hCG titers after complete uterine evacuation of a partial hydatidiform mole (PHM) or a complete hydatidiform mole. GTN patients are commonly treated with single agent treatment (methotrexate or actinomycine-D) or polychemotherapy (first line treatment EMA-CO) according to the predicted risk of resistance to single agent treatment by FIGO score. GTN patients with resistance to these treatments are treated with another single agent drug or polychemotherapy regimens.
Chemotherapy standard regimens are old and toxic for these young lady patients, with potential long term effects detrimental for further maternity and quality of life. There is a need for modern targeted agents with better benefit/toxicity profiles.
There is a strong rational for investigating the anti-PDL1 monoclonal antibody avelumab in chemoresistant GTN patients. Several elements suggest that the normal pregnancy immune tolerance is "hijacked" by GTN cell for proliferating :
* Spontaneous regressions of metastasic GTN are regularly observed, thereby the role of immune system for rejecting GTN cells.
* Strong and constant overexpression of PDL1 and NK cells has been found in all subtypes and settings of GTN tumors from French reference gestational trophoblastic center.
* The case of complete and durable response to pembrolizumab was reported in a patient with multi chemo-resistant GTN.
Conditions: Gestational Trophoblastic Neoplasias (GTN)
Intervention / Treatment:
DRUG: Avelumab administration at 10mg/kg
| Inclusion criteria for all patients :
* Woman older than 18 years - Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Patients with adequate bone marrow function :
* Absolute neutrophil granulocyte count ≥ 1.5 x 10 9 /L
* Platelet count ≥ 100 x 10 9 /L
* Haemoglobin ≥ 9.0 g/dL (may have been blood transfused).
* Patients with adequate renal function :
* Calculated creatinine clearance >= 30 ml/min according to the Cockcroft-Gault formula (or local institutional standard method)
* Patients with adequate hepatic function
* Serum bilirubin ≤ 1.5 x UNL and AST/ALT ≤ 2.5 X UNL (≤ 5 X UNL for patients with liver metastases)
* Patients must have a life expectancy ≥ 16 weeks
* Confirmation of non-childbearing status for women of childbearing potential. An evolutive pregnancy can be ruled out in the following cases:
* in case of a previous hysterectomy
* if serum hCG level ≥ 2 000 IU/L and no intra or extra-uterine gestational sac is detected on pelvic ultrasound
* if serum hCG level < 2 000 IU/L on a first measurement and serum hCG increases <100% on a second measurement performed 3 days later
* Highly effective contraception 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 must agree to use 2 highly effective contraceptions, 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.
* Patients who gave their written informed consent to participate in the study
* Patients affiliated to a social insurance regime
* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Cohort A specific inclusion criteria :
* Patients with gestational trophoblastic disease resistant to mono-chemotherapy (methotrexate and/or actinomycine-D
Cohort B specific inclusion criteria :
* Patients with gestational trophoblastic disease resistant to polychemotherapy (such as EMA-CO; EMA-EP; BEP; ... regimens) without limitation in the number of previous chemotherapy lines
* Patients with limited risk of fast progression, according to "Centre de reference des maladies trophoblastiques". In the case where a validated therapeutic alternative is available (platinum salt-based chemotherapy in case of resistance to polychemotherapy without platinum salt), the patient must have been informed and the therapeutic alternative will be proposed in priority.
Exclusion Criteria:
* Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti- CTLA 4 (including ipilimumab, tremelimumab or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways).
* Illness, incompatible with avelumab, such as congestive heart failure; respiratory distress; liver failure; allergy.
* 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.
* All subjects with brain metastases, except those meeting the following criteria:
* Brain metastases that have been treated locally and are clinically stable for at least 2 weeks prior to enrollment
* No on-going neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)
* Subjects with brain metastases must be either off steroids except a stable or decreasing dose of <10mg daily prednisone (or equivalent)
* Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used). The patient can receive a stable dose of bisphosphonates for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment with study drug.
* Persistent toxicities (>CTCAE grade 1) with the exception of alopecia and sensory neuropathy ≤ grade 2, caused by previous cancer therapy.
* Treatment with other investigational agents
* Bowel occlusive syndrome, inflammatory bowel disease, immune colitis or other gastro-intestinal disorder that does not allow oral medication such as malabsorption.
* Clinically significant (i.e active) cardiovascular disease : cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication
* Patients with severe acute or chronic medical conditions including immune pneumonitis, inflammatory bowel disease, 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.
* Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partially controlled asthma Global Initiative for Asthma 2011).
* Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness.
* Active infection requiring systemic therapy.
* Positive test for HBV surface antigen and / or confirmatory HCV RNA (if anti-HCV antibody tested positive)
* Administration of a live vaccine within 4 weeks prior the first dose of avelumab.
* Treatment with oral anticoagulant such Coumadin.
* Current or prior use of immunosuppressive medication within 7 days prior to start of study treatment. The following are exceptions to this exclusion criterion:
* Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection);
* Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent;
* Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication).
* Active autoimmune disease that might deteriorate when receiving an immunostimulatory agents. Patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
* Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control
* Resting ECG with QTc > 470msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.
* Prior organ transplantation, including allogeneic stem cell transplantation (excluding autologous bone marrow transplant)
* Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE Grade ≥ 3)
* Patients under guardianship. | 11,902 |
Study Objectives
Helicobacter pylori is a bacteria that infects the lining of the stomach and is associated with ulcers. Helicobacter pylori may also increase the long-term risk of developing certain forms of gastric cancer. Curing this infection generally requires that patients take 2 or more antibiotic medications and a stomach acid suppressing medication for about two weeks. Current treatments do not always cure the infection and a new treatment is being tested in this study. The drugs involved in the new 4 drug treatment have been widely used for treatment of this infection. It remains unknown what is the best and most cost effective way to give them. This study will compare three different ways of using these drugs.
Subjects must have active Helicobacter pylori infection in order to participate in this study.
Conditions: Helicobacter Infection
Intervention / Treatment:
DRUG: 10-day sequential treatment, DRUG: 10-day concomitant therapy
| Inclusion Criteria:
* Male or non-pregnant female aged 18 to 75 years inclusively.
* Mental and legal ability to give a written informed consent.
* Active H. pylori infection.
Exclusion Criteria:
* Previous surgery of the stomach such as partial gastrectomy.
* Use of antibiotics within the preceding 30 days.
* Regular use of bismuth compounds (>3 times per week) in the 30 days before enrollment.
* Presence of serious medical condition(s) precluding participation or endoscopy with biopsy.
* Use of concomitant medication(s) known to interact with study medication.
* Presence of Zollinger-Ellison Syndrome.
* Pregnancy or lactation.
* Allergy to any of the study medications.
* Contraindication(s) to the use of any of the study drugs.
* Participation in a clinical trial within the last 30 days.
* Unwillingness to abstain from alcoholic beverages.
* Patients taking other medications including warfarin, antipsychotics, or chronic NSAIDs will also be excluded. Aspirin at a dose not more than 325 mg/day will be permitted. | 12,286 |
Study Objectives
This study will provide long-term follow-up for patients who have received treatment with JCAR015 in a previous clinical trial. In this study, patients will be followed for up to 15 years after their last dose of JCAR015 for evaluation of delayed adverse events, presence of persisting JCAR015 vector sequences, and survival.
Conditions: Acute Lymphoblastic Leukemia
Intervention / Treatment:
GENETIC: JCAR015
| Inclusion criteria:
* Patients who have received at least one dose of JCAR015 in a previous treatment protocol.
* Patients who have provided informed consent for the long-term follow-up study prior to study participation.
Exclusion criteria:
* None. All patients who have previously received JCAR015 treatment are eligible for this long-term follow-up study. | 23,571 |
Study Objectives
This study will evaluate the safety, tolerability and pharmacokinetics of 7HP349, an allosteric integrin activator, in healthy male subjects
Conditions: Solid Tumor
Intervention / Treatment:
DRUG: 7HP349 Single Ascending Dose, DRUG: 7HP349 Multiple Ascending Dose, DRUG: Placebo Single Ascending Dose, DRUG: Placebo Multiple Ascending Dose, DRUG: 7HP349 Food Effect
| Inclusion Criteria:
* Healthy males between the ages of 18 and 45 years, inclusive
* Normal clinical chemistry, hepatic function, hematology, thyroid function
* Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 60 kg
* Agree to refrain from consuming products containing grapefruit, pomelo, star fruit or Seville oranges for at least 7 days before the first dose of study drug until the final discharge evaluation
* Positive immune status as defined in serum as measles, mumps, varicella-zoster viruses (VZR); Antibody Index (AI) ≥ 1.1, and positive Rubella: AI ≥ 1.0
Exclusion Criteria:
* Clinically significant history of disorders, infections or drug hypersensitivity as determined by the Investigator
* History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin
* Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody
* Current treatment or treatment within 30 days with another investigational medication | 7,688 |
Study Objectives
The purpose of this open-label, single-arm, multicenter, post-marketing trial is to evaluate long-term safety of Firmagon® in approximately 230 Indian patients diagnosed with advanced hormone-dependent prostate cancer requiring androgen deprivation therapy.
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: Degarelix
| Inclusion Criteria:
* Has given written informed consent before any study-related activity is performed
* Advanced hormone-dependent prostate cancer for which androgen deprivation therapy is indicated, and independently from this trial, Firmagon® is intended to be used for treatment
* Age greater than or equal to 18 years and less than 80 years
* Advanced hormone-dependent prostate cancer without any other clinically significant disorder
* Easten Cooperative Oncology Group score ≤ 2
* PSA ≥ 2 ng/mL at screening
* Life expectancy of at least 12 months as per the investigator's judgement
Exclusion Criteria:
* Previous or concurrent hormonal management of prostate cancer
* Contraindication for prescription of Firmagon®
* Concurrent treatment with a 5-α-reductase inhibitor
* Considered as a candidate for curative therapy
* History of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema
* QTc interval over 450 msec or risk factors for torsades de pointes or on Class IA and Class III anti arrhythmic medications
* Cancer within the last 5 years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin
* Known or suspected hepatic, symptomatic biliary disease (this includes moderate to severe chronic hepatic impairment)
* Patients with clinically significant laboratory abnormalities / disorders other than prostate cancer
* Patient with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) infections | 36,520 |
Study Objectives
RATIONALE: Developing a questionnaire that patients can use to assess their quality of life related to the appearance of their face after surgery may help doctors plan the best treatment for patients undergoing surgery and reconstruction for head and neck cancer in the future.
PURPOSE: This clinical trial is developing a questionnaire for assessing quality of life related to facial appearance in patients who have undergone or are planning to undergo surgery and reconstruction for head and neck cancer; and after dermatologic surgery for patients with cutaneous skin cancers.
Conditions: Head and Neck Cancer, Psychosocial Effects of Cancer and Its Treatment
Intervention / Treatment:
OTHER: questionnaire administration, PROCEDURE: assessment of therapy complications, PROCEDURE: psychosocial assessment and care, PROCEDURE: quality-of-life assessment
| Inclusion Criteria:
* Age 18 to 99 years.
* Patients who have altered facial appearance secondary to an oncologic head and neck surgical resection and reconstruction. Reconstruction will be defined as complex linear closures, skin grafts, local flaps or free tissue transfer (oncologic Post-op cohort).
* Patients who have undergone cosmetic plastic surgery procedures to the head and neck unrelated to a diagnosis of cancer (non-oncologic Post-op cohort).
* Patients with cutaneous skin cancers of the head and neck region treated in the dermatologic surgery setting (dermatology Post-op cohort)
* Patients who have completed surgery at MSKCC between 1 week to 7 years ago (Post-op cohorts).
* Patients who have completed facial surgery 6 weeks (+/- 1 week) ago (early postoperative subset-Phase I).
* Patients who are scheduled to undergo oncologic head and neck resection and reconstruction with anticipated altered facial appearance (Pre-op).
* Patients who are scheduled to undergo dermatologic surgery due to diagnosis cutaneous skin cancers of the head and neck region (dermatology Pre-op cohort)
Exclusion Criteria:
* Active psychiatric illness, cognitive or sensory impairment that in the opinion of the investigator is severe enough to preclude participation in the study.
* Moderate to severe cognitive impairment.
* Blindness.
* Physical impairment that may prevent the respondent from filling out the paper and pencil survey. | 22,827 |
Study Objectives
To explore use of a smart-phone medication reminder application to promote adherence to oral medications by AYA with cancer.
Conditions: Neoplasms
Intervention / Treatment:
| Inclusion criteria:
1)15-29 year olds receiving treatment for any type of cancer, either primary or recurrent/relapsed disease.
2) Patient has completed at least one month of therapy
3)Patient is expected to remain on therapy for 3 month duration of study
4) Patient has an iPhone, iPad, or iTouch running iOS 4.0 or later
5) Patient is willing to use a smart-phone medication reminder application-
Exclusion Criteria:
1)Patients who are unable to speak/read/write English as required for use of smart-phone medication reminder application and completion of study measures. | 3,031 |
Study Objectives
The purpose of this clinical research study is to learn if vinflunine can shrink or slow the growth of the cancer or increase survival in patients with transitional cell carcinoma of the urothelium. The safety of this treatment will also be studied.
Conditions: Transitional Cell Carcinoma, Bladder Neoplasms, Kidney Neoplasms, Ureter Neoplasms, Bladder Cancer, Neoplasm, Bladder
Intervention / Treatment:
DRUG: vinflunine
| Inclusion Criteria:
* Clinical diagnosis of transitional cell carcinoma of the urothelium that is locally advanced or metastatic (i.e. patients cannot be candidates for local/regional control of disease).
* Relapse or progression within 12.5 months of prior cisplatin or carboplatin containing chemotherapy regimen.
* Adequate performance status (Karnofsky greater or equal to 80).
Exclusion Criteria:
* Receipt of more than 1 prior chemotherapy regimen in any setting.
* Prior discontinuation of platinum due solely to toxicity.
* Current neuropathy greater or equal to CTC grade 2.
* Prior radiation to greater or equal to 30% of bone marrow.
* Inadequate hematologic function: ANC <1,500 cells/mm3, Platelet<100,000 cells/mm3.
* Inadequate hepatic function: total bilirubin > 1.5 times ULN, ALT/AST > 2.5 times ULN or > 5 times ULN in case of liver metastasis.
* Inadequate renal function: creatinine clearance <20 ml/min.
* Prior allergy to any vinca-alkaloid. | 9,792 |
Study Objectives
The purpose of this study is to evaluate diagnostic imaging techniques using 124I-NM404 PET/CT in human brain tumors. This goal will be accomplished by quantifying tumor uptake and determining the optimal PET/CT protocol, comparing PET tumor uptake to MRI, and calculating tumor dosimetry. The long-term goals of this research are to improve the diagnosis and treatment of malignant brain tumors by using radioiodinated NM404
Conditions: Glioblastoma Multiforme, Brain Metastases
Intervention / Treatment:
DRUG: NM404, DRUG: NM404
| Inclusion Criteria:
* Participants will have a contrast enhanced brain MRI which documents evidence of primary or metastatic brain tumor or suspected tumor recurrence after therapy
* Tumor size at least 1.5 cm in greatest axial dimension on MRI. MRI must be obtained within 2 months of study inclusion
* Adult patients 18 or older
* Female patients must not be pregnant or breast feeding and both women of childbearing potential, and men, must use appropriate means of contraception and must be maintained for at least 45 days after injection of 124I-NM404 Participants must not attempt to become pregnant during this time
* Platelet count must be ≥ 160,000/µl, Hematocrit must be ≥ 22%, Leukocyte count must be ≥ 3,000/µL, Creatinine must be ≤ 2.5 mg/dL, ALT must be ≤ 130 U/L, AST must be ≤ 100 U/L, and urine or serum pregnancy test must be negative for pregnancy
* Patient provides informed consent
* Karnofsky score ≥ 60
* For previously treated brain tumors, targeted brain therapy (radiation or drug) must have concluded ≥2 months prior to injection of 124I-NM404
Exclusion Criteria:
* Life expectancy of < 3 months
* Allergy to potassium iodide (SSKI or Thyroshield)
* Unwilling or unable to complete 3 separate PET/CT imaging sessions of 90 minutes each over 3 days
* Pregnancy or breast-feeding during time of study and/or anticipated breast feeding at any time for 45 days after injection of 124I-NM404. | 33,025 |
Study Objectives
Regorafenib is an oral multikinase inhibitor that blocks the activity of kinases involved in angiogenesis (VEGFR 1,2,3 and TEK), oncogenesis (KIT, Ret Proto-Oncogene (RET), Raf-1 Proto-Oncogene, Serine/Threonine Kinase (RAF1) and BRAF) and tumour growth (PDGFR and FGFR). Epithelial ovarian cancer (EOC) cell lines frequently express high levels of vascular endothelial growth factor (VEGF) and in vivo preclinical studies evaluating Regorafenib have shown promising activity in ovarian cancer. In the clinic, anti-angiogenesis therapy with bevacizumab (a monoclonal antibody to VEGF) has already emerged as an important cornerstone in the management of ovarian cancer both as part of frontline adjuvant treatment and as second-line therapy for platinum-sensitive recurrent disease. Whilst Regorafenib has been FDA approved for the treatment of patients with metastatic colorectal cancer who have failed prior bevacizumab, it's role in the management of ovarian cancer remains to be defined.
Conditions: Ovarian Neoplasms
Intervention / Treatment:
DRUG: Regorafenib
| Inclusion Criteria:
* Signed informed consent obtained before any study specific procedures. Subjects must be able to understand and willing to sign a written informed consent.* Patients with histologically and/or cytologically confirmed epithelial ovarian carcinoma (serous, clear cell, endometrioid, mucinous, mixed, carcinosarcoma and others), fallopian tube and primary peritoneal carcinoma.* Progressive disease following 2 or more prior cytotoxic chemotherapy. Patients may have received prior treatment with bevacizumab.* Age ≥ 21 years old* Eastern Cooperative Oncology Group (ECOG) performance status 0-1* Life expectancy greater than 3 months* Measurable disease by RECIST 1.1 OR non measurable but evaluable disease such as ascites and pleural effusions attributable to disease or radiologic abnormalities that did not meet RECIST criteria AND a pre-treatment serum Ca-125 level greater than or equal to 2 times the upper limit of normal on 2 occasions at least 1 week apart OR pre treatment Ca-125 level greater or equal to 2 times the upper limit of normal on 2 occasions at least 1 week apart and non evaluable, non measurable disease.* Adequate bone marrow function as shown by: absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L and haemoglobin (Hb) > 9 g/dl. Blood transfusion to meet the inclusion criteria will not be allowed.* Adequate liver function as assess by: total bilirubin ≤ 1.5 x upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN or ≤ 5.0 x ULN if liver metastases are present.* Adequate renal function as assessed by serum creatinine ≤ 1.5 x ULN and glomerular filtration rate (GFR) ≥ 30 ml/min according to Cockcroft-Gault formula.* Systolic blood pressure ≤ 160 mmHg.* Women of childbearing potential and men must agree to use adequate contraception since signing of the informed consent form until at least 3 months after the last study drug administration. The investigator or a designated associate is requested to advise the subject on how to achieve adequate birth control. Adequate contraception is defined in the study as any medically recommended method (or combination of methods) as per standard of care.* International normalized ratio (INR) ≤ 1.5 x ULN and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless receiving treatment with therapeutic anticoagulation. Patients being treated with anticoagulant e.g. heparin will be allowed to participate provided no prior evidence of an underlying abnormality in these parameters exists.
Exclusion Criteria:
* Patients who are receiving any other investigational agents.* Previous assignment to treatment during this study. Subjects permanently withdrawn from study treatment participation will not be allowed to re-enter the study.* History of allergic reactions attributed to compounds of similar chemical or biologic composition used in the study.* Prior treatment with regorafenib.* Previous or concurrent cancer that is distinct in primary site of histology from EOC within the last 5 years EXCEPT for curatively treated cervical cancer in situ, non melanoma skin cancer and superficial bladder tumours \[Ta (non invasive tumour), Tis (carcinoma in situ) and T1 (tumour invades lamina propria)\].* Patients with known brain metastases.* Uncontrolled inter-current illness including, but not limited to, on going or active infection (> Grade 2 NCI CTCAE v 4.00), symptomatic congestive heart failure (≥ New York Heart Association (NYHA) class 2), unstable angina pectoris, new onset angina (begun within the last 3 months), myocardial infarction less than 6 months before, cardiac arrhythmia requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted), pre existing poorly controlled hypertension (systolic blood pressure > 160mmHg or diastolic pressure > 90 mmHg despite optimal medical management), history of abdominal fistula, history of gastrointestinal perforation and signs or symptoms of bowel obstruction.* Subjects with phaeochromocytoma.* Other concurrent severe and/or uncontrolled concomitant medical conditions that could cause unacceptable safety risk or compromise compliance with the protocol.* Patients unable to swallow orally administered medication and patients with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of either study drug (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome).* Patients who have undergone major surgery, open biopsy of significant traumatic injury ≤ 28 days prior to starting study drug.* Patient with bowel resection within the past 1 year.* Patients with a past history of bowel perforation and abdominal fistula; patients with a recent history of bowel resection (within the past 12 months) and/or patients with symptoms of radiological evidence of active bowel obstruction.* Extended field radiotherapy within 4 weeks or limited field radiotherapy within 2 weeks prior to randomization. Patients must have recovered from all therapy related toxicities. The site of previous radiotherapy should have evidence of progressive disease if this is the only site of disease.* Patients with venous thromboembolism disease or pulmonary embolism within 6 months before start of study medication (except for adequately treated catheter-related venous thrombosis occurring more than one month before the start of study medication).* Arterial thrombotic event including transient ischaemic attack (TIA), cerebrovascular accident (CVA) and peripheral arterial embolus within the last 6 months before start of study medication.* Subjects with evidence or history of any bleeding diathesis irrespective of severity.* Non-healing wound, ulcer or bone fracture.* Known history of human immunodeficiency virus (HIV) infection.* Subjects with seizure disorder requiring medication.* History of organ allograft.* Renal failure requiring haemo- or peritoneal dialysis.* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.* Interstitial lung disease with on-going signs and symptoms at the time of informed consent.* Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy and hormonal therapy during this trial or within 4 weeks (or 6 weeks for nitrosurea, antibodies or mitomycin-C) prior to starting study drug or who have not recovered from side effects of such therapy.* Pregnant or breast-feeding in females. Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of treatment.* Inability to attend or comply with treatment of follow-up scheduling.* Persistent proteinuria > 3.5g/24 hours measured by urine protein-creatinine ratio from a random urine sample* Any haemorrhage or bleeding event ≥ CTCAE Grade 3 within 4 weeks prior to the start of study medication* Active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy | 31,618 |
Study Objectives
It is unclear whether the use of fluids given by a "drip" is beneficial to cancer patients in the last days of life, and as a result many individuals do not receive such treatment (although they do receive fluids by mouth, and regular mouth care). The researchers want to undertake a large study ("main study") to determine the benefits of fluids given by a drip, but first need to undertake a small study ("feasibility study") to ensure that the main study can be done.
The feasibility study will be done in twelve units (hospitals, hospices) in England \& Wales; each unit will be allocated a treatment at random, and all patients in the unit will receive that treatment (if appropriate). Standard treatment A consists of drinking fluids (if possible), regular mouth care, and treatment of any symptoms; standard treatment B consists of drinking fluids (if possible) , regular mouth care, fluids by a drip, and treatment of any symptoms.
Patients will be assessed on a four hourly basis, and any uncontrolled symptoms will be recorded. The main symptom of interest is agitation ("delirium"), which has multiple causes, including dehydration and kidney failure. Uncontrolled symptoms will be appropriately treated, e.g. patients with pain will be given painkillers. Equally, problems relating to the fluids given by a drip will also be recorded. Involvement in the study will not interfere with the patient's general care, and there will be no additional blood or other tests.
Conditions: Cancer
Intervention / Treatment:
OTHER: Non-Clinically Assisted Hydration arm, OTHER: Clinically Assisted Hydration arm
| Inclusion criteria:
* Diagnosis of cancer
* Age ≥ 18 yr
* Estimated prognosis of ≤ 1 week
* Patient unable to maintain sufficient oral intake (1L / day)
Exclusion criteria:
* Patient clinically dehydrated
* Patient has hyperactive delirium ("terminal agitation") at present
* Patient has had hyperactive delirium ("terminal agitation") in the last 24hr
* Clinical indication for clinically-assisted hydration (e.g. hypercalcaemia)
* Clinical contra-indication to clinically-assisted hydration (e.g. cardiac failure)
* Clinical contra-indication to peripheral cannulation
* Intravenous fluids / subcutaneous fluids / total parenteral nutrition (TPN) / enteral feeding or fluids already being administered
* Patient likely to be transferred to another setting for end of life care (e.g. home, hospice) | 16,664 |
Study Objectives
This phase I/II trial studies the side effects of panobinostat nanoparticle formulation MTX110 (MTX110) in treating participants with newly-diagnosed diffuse intrinsic pontine glioma. Panobinostat nanoparticle formulation MTX110 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Conditions: Diffuse Intrinsic Pontine Glioma
Intervention / Treatment:
DRUG: Panobinostat Nanoparticle Formulation MTX110, DRUG: Convection-Enhanced Delivery (CED)
| Inclusion Criteria:
* Patients with newly diagnosed DIPG by magnetic resonance imaging (MRI); defined as patients with a pontine location and diffuse involvement of at least 2/3 of the pons are eligible without histologic diagnosis. For lesions with typical imaging features, biopsy is neither encouraged nor required for eligibility. Tumors that are biopsied will be eligible if proven to be supportive of the diagnosis of a DIPG. Consensus of diagnosis by the study team must be met.
* Patients who have completed focal radiotherapy within 14 weeks from time of enrollment are eligible.
* Treatment must begin at a minimum of 4 weeks after, but no later than 14 weeks after, the date of completion of focal radiotherapy.
* Prior chemotherapy: Patients should be at least 30 days from last chemotherapy dose prior to start of CED infusion, with exception of antibody half-lives. For antibody therapies, at least 3 half-lives of the antibody after last dose of monoclonal antibody should have passed prior to CED infusion. Patients less than 30 days from last chemotherapy dose should be discussed with the study chair(s).
* Prior radiation: Patients must have received prior treatment with focal radiotherapy as part of initial treatment for DIPG and had their last dose at least 4 weeks prior to and no later than 14 weeks from the first CED treatment. Standard focal radiation therapy will include 54 to 60 Gy by external beam radiotherapy to the brainstem.
* Age ≥ 2 years of age to 21 years. Patients younger than 3 years of age may be enrolled on study at the discretion of the Study Chair(s) if supporting evidence that brainstem lesion represents a brainstem glioma.
* Karnofsky Performance Score ≥ 50 for patients > 16 years of age and Lansky Performance Score ≥ 50 for patients ≤ 16 years of age. Patients who are unable to walk because of paralysis, but who are able to mobilize using a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
* Life expectancy of greater than 12 weeks measured from the date of completion of radiotherapy.
* Corticosteroids: Patients who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to registration.
* Peripheral absolute neutrophil count (ANC) ≥ 1000/mm\^3.
* Hemoglobin ≥ 8g/dl.
* Platelet count ≥ 100,000/mm\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).
* Normal coagulation defined as normal International Normalized Ratio (INR) or per institutional guidelines.
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 milliliters (mL)/minute (min)/1.73 m\^2.
* A serum creatinine (mg/dL) based on age/gender as follows:
* Age: 2 to < 6 years; Male: 0.8; Female: 0.8
* Age: 6 to < 10 years; Male: 1; Female: 1
* Age: 10 to < 13 years; Male: 1.2; Female: 1.2
* Age: 13 to < 16 years; Male:1.5; Female: 1.4
* Age ≥ 16 years; Male: 1.7; Female: 1.4
* Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x upper limit of normal (ULN) for age.
* Serum glutamate pyruvate transaminase (SGPT) \[alanine aminotransferase (ALT)\] ≤ 110 U/L.
* Serum albumin ≥ 2 g/dL.
* Patients with seizure disorder may be enrolled if on non-enzyme inducing anticonvulsants and well controlled.
* The effects of MTX110 on the developing human fetus are unknown. For this reason 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 4 months after completion of MTX110 injection administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
* Able to understand, and willing to sign, a written informed consent document.
* Patients who are unable to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy.
Exclusion Criteria:
* Patients who had clinical and/or radiographic (MRI) progression of tumor following external beam radiation therapy.
* Patients with metastatic disease, including leptomeningeal or subarachnoid disseminated disease.
* Patients with tumor morphology that predicts poor coverage of the majority of the tumor including bilateral thalamic involvement, or cysts that represent > 50% of cross-sectional areas of the pons. These subjects should be discussed with the study chairs.
* Patients who are receiving any other investigational agents or other tumor-directed therapy.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to MTX110 or gadolinium.
* 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.
* Female patients of childbearing potential must not be pregnant or breast-feeding. Female patients of childbearing potential must have a negative serum or urine pregnancy test within 14 days of registration.
* Patients with MRI or clinical evidence of uncontrolled tumor mass effect are excluded; the assessment of mass effect should be made by the study chairs and study neurosurgeons prior to any planned CED treatment.
* Untreated symptomatic hydrocephalus determined by treating physician.
* Patients with evidence of intra-tumoral hemorrhage > 5 mm maximal diameter. These subjects should be discussed with the study chair.
* Subjects with prolonged corrected QT (QTc) (> 450 msec) will be excluded from the study. | 28,650 |
Study Objectives
Sarcomas are rare tumours that represent less than 1% of cancers. Their actual incidence in France, however, is not known. The chances of survival at 5 years, without signs of the disease, are currently estimated at about 60%. The possibility of soft tissue sarcoma (STS) is frequently unrecognised, leading to an inappropriate initial diagnostic process and often to inadequate surgery. Compliance with good practice guides, which we can recall were targeted at oncologists, is good when the patient's record is discussed within the framework of a multidisciplinary consultation. The consequences of inadequate initial management, however, can be critical: unplanned surgery results in the need for systematic repeat procedure, with residual tumour found in more than half of cases, and the absence of multidisciplinary care has a deleterious impact on local disease control and specific survival.
The objective of the study is to measure the impact of a public health intervention programme focused on the initial management of STS among all professionals who may come to suspect or diagnose soft tissue sarcoma. For this project, the 4 regions involved in the Cancéropôle du Grand Sud-Ouest, France (Aquitaine, Languedoc-Roussillon, Limousin and Midi-Pyrénées) propose to implement actions targeted at general practitioners, treating physicians and non-specialist surgeons in the field of STS, aimed at improving initial care.
An improvement in initial management (diagnosis and assessment) which should allow an improvement in the loco-regional control of these diseases and in the specific survival of the patients. The actions recognised as effective in this study could then be adapted and extended to the rest of France via the French sarcomas group and the bone tumours study group (GSF-GETO).
Conditions: Sarcoma
Intervention / Treatment:
OTHER: Public Health intervention programme, OTHER: No public Health intervention programme
| Inclusion Criteria:
* Primary soft-tissue sarcoma (STS)
* any stage
Exclusion Criteria:
* Patients with visceral, bone, uterus or Kaposi's sarcoma, gastrointestinal stromal tumors, or mesotheliomas | 18,656 |
Study Objectives
Prostate cancers, in common with many other tumours, are often hypoxic; that is, they have low levels of oxygen. It is thought that tumour hypoxia may hasten the progression of cancers and make them more resistant to treatment. One previous study has suggested that hormone therapy, such as Casodex, may improve the prostate oxygen level. This study is designed to test that finding.
Conditions: Prostatic Neoplasms
Intervention / Treatment:
PROCEDURE: hypoxia measurement
| Inclusion Criteria:
* Men with histologically proven prostatic carcinoma, stage cT2, N0, M0, receiving neoadjuvant bicalutamide plus conformal radiotherapy in study 9907, who have previously participated in the prostate cancer hypoxia project
* informed consent
Exclusion Criteria:
* Coagulopathy | 9,880 |
Study Objectives
The primary purpose of this study is to examine the effect of a brief preoperative smoking intervention on postoperative complications in women undergoing breast cancer surgery.
Secondary purposes are to examine long-term smoking cessation rates and experienced stress and nicotine withdrawal symptoms during the smoking cessation period.
Conditions: Breast Cancer, Smoking
Intervention / Treatment:
BEHAVIORAL: Brief preoperative smoking intervention
| Inclusion Criteria:
* Woman
* Scheduled for elective breast cancer surgery
* Daily smoker
* Age 18 years and above
* Able to read and write Danish
* Informed consent.
Exclusion Criteria:
* Alcohol intake >35 units per week
* Diagnosed psychiatric disease (including substance abuse and dementia)
* ASA IV and V
* Preoperative neo-adjuvant chemotherapy
* Ulcerating cancer
* Pregnancy and breast-feeding. | 26,747 |
Study Objectives
The aim of the study is to examine the head and neck paraganglioma cases treated in Pamukkale University hospital between 2007-2023 and improve our understanding of these cases and contribute to the knowledge surrounding head and neck paragangliomas.
Conditions: Head and Neck Paraganglioma
Intervention / Treatment:
| Inclusion Criteria:
* Histopathological diagnosis of carotid paraganglioma
* Histopathological diagnosis of vagal paraganglioma
* Histopathological diagnosis of jugular paraganglioma
* Histopathological diagnosis of tympanic paraganglioma
Exclusion Criteria:
*Inadequate information in files | 18,507 |
Study Objectives
Transurethral resection of bladder tumor (TURB) has been essential treatment for bladder tumours. Direct electrical stimulation of an obturator nerve during the TURB procedures can trigger an inadvertent adductor muscle spasm, which can cause a serious complication like bladder perforation.
General anesthesia with muscle relaxants for TURB does not guarantee a prevention of the adductor muscle spasm. Spinal anesthesia with selective obturator nerve block (ONB) can be an alternative anesthesia for TURB, but adductor spasm can also be induced because of incomplete ONB. Recently, ultrasound guidance with nerve stimulator has been used to enhance the safety, efficacy and shortening the onset time of ONB.
Some papers describe that comparable ONB can be done using ultrasound only without nerve stimulator, in which there is a principle that obturator nerve runs along a given pathway. Basically, obturator nerve is divided into two branches after exiting the obturator canal. The anterior branch is located in the fascial planes among adductor longus, adductor brevis and pectineus muscles, and the posterior branch is located between the adductor brevis and adductor magnus muscles at the inguinal area. But it has been known that there are many branching patterns of obturator nerve and high anatomic variability in the inguinal area in a cadaver study. And subdivisions of obturator nerve in the inguinal area have been described.
Therefore, this study was conducted to investigate the success rate of ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group) was comparable to ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) in TURB under spinal anesthesia. And we also evaluated adductor muscle twitching patterns at the inguinal region when the ONB was performed.
Conditions: Bladder Cancer
Intervention / Treatment:
DEVICE: nerve stimulator (stimuplex HNS12), DEVICE: ultrasound
| Inclusion Criteria:
* all patients anticipating transurethral resection of bladder tumors with American Society of Anesthesiologists physical status(ASA) I or II
Exclusion Criteria:
* patients with diabetes or peripheral neuropathy; motor or sensory deficits in the lower extremities, ASA greater than III, coagulation disorders, anticoagulant medication, known allergy to local anesthetics, contraindications for spinal anesthesia (infection at injection site, severe scoliosis or fusion operation), uncooperative patients and patients' refusal | 2,501 |
Study Objectives
The goal of this retrospective observational study is to evaluate the prognostic value of nutrition assessment tool in advanced cancers. We aim to evaluate the clinical utility of nutrition assessment tool in predicting the clinical outcomes of cancer patients, which would help the clinicians to make tailored decision for this population.
Conditions: Advanced Cancer, Nutrition Aspect of Cancer, Prognostic Cancer Model
Intervention / Treatment:
| Inclusion Criteria:
* Advanced cancers
Exclusion Criteria:
* Aged below 18
* Incomplete blood tests
* Incomplete follow-up data | 20,701 |
Study Objectives
This clinical trial studies how well early stem cell transplantation works in treating patients with high-grade myeloid neoplasms that has come back after a period of improvement or does not respond to treatment. Drugs used in chemotherapy, such as filgrastim, cladribine, cytarabine and mitoxantrone hydrochloride, 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 chemotherapy before a donor peripheral blood cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells. Early stem cell transplantation may result in more successful treatment for patients with high-grade myeloid neoplasms.
Conditions: Blasts 10 Percent or More of Bone Marrow Nucleated Cells, Chronic Myelomonocytic Leukemia-2, High Grade Malignant Neoplasm, Myelodysplastic Syndrome, Myelodysplastic Syndrome With Excess Blasts-2, Myeloid Neoplasm, Previously Treated Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Intervention / Treatment:
DRUG: Cladribine, DRUG: Cyclosporine, DRUG: Cytarabine, BIOLOGICAL: Filgrastim, DRUG: Fludarabine Phosphate, PROCEDURE: Allogeneic Hematopoietic Stem Cell Transplantation, OTHER: Laboratory Biomarker Analysis, DRUG: Melphalan, DRUG: Mitoxantrone Hydrochloride, DRUG: Mycophenolate Mofetil, OTHER: Questionnaire Administration, DRUG: Sirolimus, RADIATION: Total-Body Irradiation, DRUG: Melphalan Hydrochloride
| Inclusion Criteria:
INCLUSION CRITERIA (ENROLLMENT)
* Relapsed or refractory high-grade myeloid neoplasms, defined as having a blast count of >= 10% blasts at initial diagnosis; examples include excess blasts (EB)-2, with >= 10% blasts at initial diagnosis, acute myeloid leukemia (AML) or chronic myelomonocytic leukemia (CMML-2); standard definitions of relapse will apply (i.e., characterized by >= 5% abnormal blasts or blast equivalents as assessed by multiparameter flow cytometry or morphologic examination; peripheral blood blasts or blast equivalents; or extramedullary granulocytic sarcoma, per European LeukemiaNet \[ELN\] 2017 guidelines); bone marrow aspirate/biopsy will be accepted if performed outside University of Washington/Fred Hutchinson Cancer Research Center (UW/FHCRC); determination of disease status should occur within 30 days of signing informed consent
* R/R high-grade myeloid neoplasm following intensive induction chemotherapy; relapsed high-grade myeloid neoplasm: patients will be classified as relapsed if they have >= 5% blasts after being in a complete remission (CR) following treatment for high-grade myeloid neoplasm; refractory high-grade myeloid neoplasm: patients may be classified as refractory if they have received at least one prior cycle of induction chemotherapy, whether with cladribine cytarabine mitoxantrone (GCLAM) or another regimen
\*\* Patients may have received up to two courses of intensive induction chemotherapy during initial treatment prior to enrollment on this protocol; for example, patients who have received two courses of granulocyte colony stimulating factor (G-CSF) GCLAM (or similar) chemotherapy, with most recent high-dose cytarabine-containing chemotherapy > 6 months ago and CR lasting > 6 months, will be eligible for this protocol; regimens "similar to GCLAM" would include cytarabine at doses of 1g/m\^2 for at least 5 doses; examples of regimens "similar to GCLAM" would be GCLA, fludarabine cytarabine granulocyte (FLAG), and FLAG-idarubicin (ida); however, patients who received more than two courses of GCLAM (or similar) chemotherapy, or patients who received two courses of GCLAM and had CR lasting < 6 months, would not be eligible
* R/R high-grade myeloid neoplasm following less intensive induction chemotherapy. Patients who have received at least three cycles of treatment with a hypomethylating agent (HMA; such as azacitidine or decitabine) and still have >= 10% blasts will be eligible for the study (they will be considered refractory); similarly, patients who have received three or more cycles of HMA therapy who have had a response (e.g., achieving CR with < 5% blasts), but who then progress using standard definitions of relapse, will also be eligible (they will be considered relapsed)
* Potentially eligible for reduced intensity conditioning based on known organ function (formal organ function testing may occur after consent)
* Caregiver capable of providing post-HCT care
* Written informed consent
INCLUSION CRITERIA (TRANSPLANT)
* Identified donor (see DONOR SELECTION below for further details)
* Matched related or unrelated (one allele mismatch in HLA-A, B, or C OK) donor according to institutional standards
* Unrelated volunteer donor who is mismatched with the recipient (i.e. 9/10 match)
* Caregiver capable of providing post-HCT care, who will be present once induction therapy with filgrastim, cladribine, cytarabine, mitoxantrone hydrochloride (GCLAM) begins
* Written informed consent for transplant
* Either bone marrow or peripheral blood is allowed
Exclusion Criteria:
EXCLUSION CRITERIA (ENROLLMENT)
* Prior allogeneic HCT
* More than two prior courses of induction chemotherapy
* Relapse after minimal residual disease (MRD)-negative CR within 3 months of most recent GCLAM chemotherapy
* Low likelihood of being eligible for reduced intensity conditioning HCT based on known information
* Cardiac ejection fraction < 40% or symptomatic coronary artery disease or uncontrolled arrhythmia, as assessed by multigated acquisition (MUGA) or transthoracic echocardiography (TTE) within previous 3 months and since the most recent anthracycline exposure
* Corrected diffusing capacity of the lungs for carbon monoxide (DLCOc) < 40% or forced expiratory volume in 1 second (FEV1) < 50%
* Estimated glomerular filtration rate (GFR) < 40 ml/min
* Need for supplemental oxygen
* Direct bilirubin or alanine aminotransferase (ALT) > 2 x upper limit of normal, unless these abnormalities are thought to be related to Gilbert's disease or leukemic infiltration of hepatic parenchyma
* Known human immunodeficiency virus (HIV) positivity
* Pregnant or nursing (to be confirmed with quantitative human chorionic gonadotropin \[HCG\] testing)
* Invasive solid tumor within 5 years; non-melanoma skin cancer or in situ malignancies are allowed
* Evidence of serious uncontrolled infection
* Eastern Cooperative Oncology Group (ECOG) of 3 or 4
* EXCLUSION CRITERIA (TRANSPLANT)
* Donor specific antibodies against donor HLA-DQ or -DP
* Active bacterial, fungal or viral infections unresponsive to medical therapy
* Active leukemia in the central nervous system (CNS)
* HIV positive
* Cardiac ejection fraction < 40% or symptomatic coronary artery disease or uncontrolled arrhythmia
* DLCOc < 40% or FEV1 < 50%
* Estimated GFR < 40 ml/min
* Need for supplemental oxygen
* Direct bilirubin or ALT > 2 x upper limit of normal, unless these abnormalities are thought to be related to Gilbert's disease or leukemic infiltration of hepatic parenchyma
DONOR SELECTION:
Identification of an appropriate donor will follow the general guidelines listed below.
* HLA-matched related or unrelated donor. Donors must be:
* Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing
* Only a single allele disparity will be allowed for HLA-A, B, or C as defined by high resolution typing
* HLA-mismatched unrelated donor. Unrelated volunteer donors who are mismatched with the recipient within one of the following limitations will be permitted:
* Mismatch for one HLA class I antigen with or without an additional mismatch for one HLA-class I allele, but matched for HLA-DRB1 and HLA-DQ, OR
* Mismatched for two HLA class I alleles, but matched for HLA-DRB1 and HLA-DQ
* HLA class I HLA-A, -B, -C allele matched donors allowing for any one or two DRB1 and/or DQB1 antigen/allele mismatch
HLA-matching must be based on results of high resolution typing at HLA-A, -B, -C, -DRB1, and -DQ. If the patient is homozygous at the mismatch HLA class I locus or II locus, the donor must be heterozygous at that locus and one allele must match the patient (i.e., patient is homozygous A\*01:01 and donor is heterozygous A\*01:01, A\*02:01) | 2,896 |
Study Objectives
This was a Phase 1, multicenter, open-label, clinical trial in adult subjects with metastatic castrate resistant prostate cancer who progressed after both hormonal therapy (abiraterone or enzalutamide) and chemotherapy (docetaxel), or cannot tolerate either or both therapies.
The study involved a Phase 1 dose escalation of oral GT0918 to evaluate its safety, tolerability, pharmacokinetics and pharmacodynamics.
Conditions: Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Intervention / Treatment:
DRUG: GT0918
| Inclusion Criteria:
* Written informed consent obtained prior to any study-related procedure being performed.* Subjects at least 18 years of age or older at the time of consent.* Histologically confirmed metastatic castrate resistant cancer (mCRPC) who progressed after both hormonal therapy (abiraterone or enzalutamide) and chemotherapy (docetaxel, for example); or cannot tolerate either or both of these classes of therapies.* Ongoing androgen deprivation therapy with a luteinizing hormone-releasing hormone (LHRH) "super-agonist" or antagonist, or bilateral orchiectomy and serum testosterone level < 50 ng/dL (< 0.5 ng/mL, < 1.7 nmol/L) at screening.* Metastatic disease documented by computed tomography (CT)/magnetic resonance imaging (MRI) or bone scan.* Progressive disease despite ongoing androgen deprivation or chemotherapy. Progressive disease is defined by 1 or more of the following criteria:
* Subjects with a rising PSA value > 2 ng/mL in at least 2 measurements, at least 1 week apart. If the confirmatory PSA value is less than the screening PSA value, then an additional test for the rising PSA is required to document progression.
* Subjects with measurable disease, progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
* Subjects with metastatic bone disease, progression defined by 2 or more new lesions in a radionuclide bone scan.* ECOG performance status of 0-2 (dose escalation phase); ECOG performance status of 0-1 (expansion phase).* Screening blood counts of the following:
* Absolute neutrophil count ≥ 1500/μL
* Platelets ≥ 100,000/μL
* Hemoglobin > 9 g/dL* Screening chemistry values of the following:
* Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 × upper limit of the normal reference range (ULN)
* Total bilirubin ≤ 2 × ULN
* Creatinine ≤ 1.5 × ULN
* Albumin > 2.8 g/dL.* At screening, life expectancy of at least 3 months.* Subjects whose partners are women of childbearing potential (WOCBP) must use an adequate method of birth control while on study drug and at least for 3 weeks after discontinuation of study drug.* Subject is willing and able to comply with all protocol required visits and assessments.
Exclusion Criteria:
* Subjects with life expectancy less than 3 months.* Discontinuation of bicalutamide or nilutamide less than 6 weeks, and other antiandrogens less than 4 weeks, abiraterone less than 3 weeks, prior to the start of study medication.* Prior chemotherapy, radiation, sipuleucel-T or other experimental immunotherapy less than 4 weeks prior to the start of study medication.* Prior chemotherapies more than 2 lines (Phase II part only) .* Ongoing acute treatment-related toxicity associated with a previous therapy greater than grade 1 except for grade 2 alopecia or neuropathy.* History of impaired adrenal gland function (eg, Addison's disease, Cushing's syndrome).* Known gastrointestinal disease or condition that affects the absorption of GT0918.* History of congestive heart failure New York Heart Association (NYHA) class III or IV or uncontrolled hypertension at screening.* History or family history of long QT syndrome.* History of other malignancy within the previous 3 years, except basal cell or squamous cell carcinoma, or non-muscle invasive bladder cancer.* Use of systemic glucocorticoid (eg, prednisone, dexamethasone) within 14 days prior to the start of study medication.* Co-administration of CYP3A4 ligands that serve as substrates or induce or inhibit the enzyme.* Prior use of any herbal products known to decrease PSA levels (eg, PC-SPES or saw palmetto) within 30 days prior to the start of study medication.* Major surgery within 30 days prior to the start of study medication.* Blood transfusion (including blood products) within 1 week of screening.* Serious persistent infection within 14 days prior to the start of study medication.* Serious concurrent medical condition including CNS disorders.* Previous history of difficulty swallowing capsules.* Known hypersensitivity to GT0918 or its excipients.* Any condition that, in the opinion of the investigator, would impair the subject's ability to comply with study procedures. | 6,291 |
Study Objectives
Cancer awareness is a critical element of cancer prevention and control. Creating public awareness on risk factors, preventative strategies, and the importance of early screening is the foundation upon which a cancer control program must be constructed. The purpose of this study is to describe the sociodemographic and risk factor distribution of the Abuja, Nigeria "World Cancer Day Walk" participants according to their motive for participating in the event (free cancer screening versus fun/activities), and secondarily, to investigate the impact of the event on educating attendees from the general population about cancer prevention and screening, in particular the importance of being physically active and maintaining a healthy body weight. Obesity is a known risk factor contributing to the development of cancer and NCD's.
Conditions: Cancer Prevention
Intervention / Treatment:
BEHAVIORAL: Healthy Lifestyle Education
| Inclusion Criteria:
* Male and Female age 18 and over
* Willing and able to converse and/or read and write in either English or Pidgin English.
Exclusion Criteria:
\* Participants who are unable to provide informed consent to the study due to cognitive or physical impairment, based on self-report. | 13,184 |
Study Objectives
In this pilot study, eligible pediatric patients will be treated with 5 consecutive days of low dose daunorubicin. All patients who receive low dose daunorubicin will be evaluated daily for potential toxicity during those 5 days. Once the patient has received 5 doses of daunorubicin, subsequent therapy will be at the discretion of the primary oncology team.
Conditions: Relapsed Pediatric ALL, Relapsed Pediatric AML, Refractory Acute Myeloid Leukemia, Refractory Acute Lymphoblastic Leukemia
Intervention / Treatment:
DRUG: Daunorubicin
| Inclusion Criteria:
* Patients with pathologically confirmed ALL or AML, whose disease is refractory to two induction therapeutic attempts, or who are in 2nd or greater relapse, or who are in 1st relapse or refractory to a single therapeutic attempt but are unable to receive intensive therapy at the time of consent.
* All prior upfront therapies including bone marrow transplant are acceptable. Pulse steroids (of 5 days duration or less in the prior month) administered as part of a routine maintenance therapy are acceptable.
* Age 1 to 21 years of age, inclusive
* Established central catheter IV access
Exclusion Criteria:
* Females who are known to be pregnant or lactating
* Any Grade 3 or higher Cardiac Disorder per CTCAE version 5
* Patients with echocardiographic evidence of cardiomyopathy (shortening fraction <27% or ejection fraction <50%)
* Uncontrolled sepsis
* Absolute Blast Count >50 x10(3)/mcL at enrollment or on day 1 of study
* Direct hyperbilirubinemia >5mg/dL
* Grade 3 or higher anaphylaxis to daunorubicin
* Non-English speaking
* Patients, who in the opinion of the PI, are unable to tolerate any study-specific procedures
* Patients who have received cyclosporine, tacrolimus or other agents to prevent or treat graft-vs-host disease post bone marrow transplant in the last 14 days
* Concurrent investigational drugs or other chemotherapeutic agents (excluding hydroxyurea), immunotherapies or biosimilars during the 5 days of daunorubicin.
* Prior cumulative doses of anthracyclines will not be an exclusion regardless of the total cumulative dose previously received. | 1,863 |
Study Objectives
This project which is fully funded by the European Union FP7 Program is designed to pull together all the information we obtain from scans and x-rays to design a personalised 3-D digital model of each patient, their anatomy and disease. We can then use this as follows: as (i) an aid to surgical planning to enable objective clinical decision making (ii) a decision support tool to communicate the available treatment options to the patient and facilitate shared decision making and provision of personalised care and (iii) to enable standardised objective evaluation of the aesthetic outcome of the treatment procedures. This study aims to demonstrate the ability of the Virtual Physiological Human concept to empower breast cancer patients and assess the impact on their care and quality of life.
Conditions: Early-Stage Breast Carcinoma
Intervention / Treatment:
| Inclusion Criteria:
* Women who have undergone breast conserving surgery for early breast cancer more than one year ago.
* Written informed consent obtained.
Exclusion Criteria:
* Unable to provide written informed consent.
* Younger than 18 years.
* Benign breast disease.
* Women who have had a mastectomy. | 8,564 |
Study Objectives
Hepatocellular carcinoma (HCC) has a global importance due to its high rate of progression and high mortality rates. Significant risk factors for the development of HCC are metabolic syndrome, obesity and type 2 diabetes mellitus(T2DM). Dysregulation of adipose tissue derived hormones(adipocytokines/adipokines) might also be involved in obesity-related liver carcinogenesis \& due to the wide spectrum of visfatin and vaspin activities ,we focus in this study on their potential role in patients with HCV-related liver cirrhosis with and without HCC on top.
Conditions: Hepatocellular Carcinoma
Intervention / Treatment:
| Inclusion Criteria:
* The diagnosis of CHC will be based on positive HCV antibodies by enzyme-linked immunosorbent assay(ELIZA)\& HCV RNA by Polymerase chain reaction ( PCR) for more than 6 months. The diagnosis of liver cirrhosis will be based on clinical data and findings on abdominal ultrasound. The diagnosis of HCC will be based on the typical features of dynamic imaging by triphasic CT with or without elevated serum alpha-fetoprotein (AFP) .
Exclusion Criteria:
* - Co-infection with HBV.
* Presence of clinically suspected other causes of hepatocellular injury ( any history of alcoholism, autoimmune hepatitis, primary sclerosing cholangitis (PSC), primary biliary cholangitis (PBC), Wilson's disease, fatty liver disases with metabolic syndrome \&drug induced liver disease.
* Patients diagnosed with other malignancies.
* Patients with history of prior local or systemic HCC-specific treatment. | 36,534 |
Study Objectives
The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab, BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient responses and time to disease progression. Eligible patients are those who in response to a single regimen containing interleukin-2 (IL-2), dacarbazine, and/or temozolomide, have 1) relapsed following an objective response (partial response/complete response \[PR/CR\]); 2) failed to demonstrate an objective response (PR/CR); or 3) could not tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379 alone, or MDX-010 in combination with MDX-1379.
Conditions: Melanoma, Metastases
Intervention / Treatment:
DRUG: MDX-010 (anti-CTLA4) monoclonal antibody, BIOLOGICAL: MDX-1379 (gp100) Melanoma Peptide Vaccine
| Inclusion Criteria:
* Diagnosed with malignant melanoma
* Measurable unresectable Stage III or IV melanoma
* HLA-A\*0201 positive
* Previous treatment with \& failure/relapse/inability to tolerate IL-2, dacarbazine and/or temozolomide
* At least 4 weeks since prior treatment
* Negative pregnancy
* Life expectancy greater than 4 months
* Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1
* Required lab values
* Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) negative
Exclusion Criteria:
* Prior malignancies which the patient has not been disease free for over 5 years, except treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or any other cancer
* Ocular melanoma
* Active, untreated central nervous system (CNS) metastasis
* Prior treatment with MDX-010 (anti-CTLA4) antibody
* Prior treatment with any cancer therapeutic vaccine
* Active autoimmune disease or history of autoimmune disease
* Pregnancy or nursing
* Hypersensitivity to Incomplete Freund's Adjuvant (IFA) (Montanide ISA-51)
* Underlying medical conditions deemed hazardous if treated with study drug
* Concomitant therapy with anti-melanoma drugs, chemotherapies, other investigational therapies, chronic use of systemic corticosteroids
* Unable to provide informed consent | 37,150 |
Study Objectives
This study is investigating the efficacy of PD-L1 and PD-L2 peptides in untreated CLL patients with unmutated IGHV gene status.
Conditions: Chronic Lymphocytic Leukemia
Intervention / Treatment:
COMBINATION_PRODUCT: PD-L1, PD-L2 peptides with Montanide ISA51
| Inclusion Criteria:
* CLL according to national guidelines (Lymphoma.dk).
* Unmutated IGHV gene according to ERIC recommendations.(25)
* No prior CLL directed treatment
* Age ≥ 18
* Eastern cooperative oncology group (ECOG) performance status of 0 or 1
* No life-threatening conditions
* Adequate bone marrow function: Neutrophils > 1,0 x 109/l; Platelets > 100 x 109/l
* Adequate renal function: Glomeruli filtration rate (eGFR)/1,73 m2 > 50 mL/min
* Adequate liver function: Aspartate Aminotransferase < 100 U/L
* For fertile women: agreement to use contraceptive methods with a failure rate of < 1% per year during the treatment period and for at least 120 days after the last treatment.
* For men: agreement to use contraceptive measures and agreement to refrain from donating sperm.
Exclusion Criteria:
* Other active malignant diseases requiring treatment.
* Significant medical condition per investigators judgement e.g. severe Asthma or chronic obstructive lung disease (COLD), poorly regulated heart condition, insulin dependent diabetes mellitus.
* Acute or chronic viral/bacterial infection e.g. human immunodeficiency virus (HIV), Cytomegalo virus (CMV), Epstein-barr virus (EBV), hepatitis or tuberculosis
* Serious known allergies or earlier anaphylactic reactions.
* Known sensibility towards Montanide ISA51
* Any active autoimmune diseases e.g. autoimmune neutropenia, thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, autoimmune glomerulonephritis, autoimmune adrenal deficiency, autoimmune thyroiditis etc.
* Pregnant and breastfeeding women.
* Fertile women not using secure contraception with a failure rate less than < 1%
* Psychiatric disorders that according to the investigator could influence compliance.
* Treatment with other experimental drugs | 20,066 |
Study Objectives
The primary objective of this study is to explore the efficacy of BIBW 2992 compared with cetuximab (Erbitux) in patients with metastatic or recurrent head and neck cancer after failure of platinum-containing therapy. In addition, the trial aims to clarify the influence of EGFR genotype on tumor response to the treatment regimens.
Conditions: Head and Neck Neoplasms, Carcinoma, Squamous Cell
Intervention / Treatment:
DRUG: BIBW 2992, DRUG: Cetuximab
| Inclusion criteria:
* Metastatic (stage IVc) or recurrent HNSCC 2. Histologically or cytologically confirmed diagnosis of squamous cell of the head and neck. Patients with well-differentiated (keratinizing) nasopharyngeal carcinomas and patients with squamous cell carcinomas metastatic to the neck from an unknown head and neck primary are eligible. 3. Patients must have documented progressive disease (PD) following receipt of prior platinum-based therapy (either as neoadjuvant, adjuvant, concomitant with radiotherapy, or for recurrent/ metastatic disease). 4. Patients must have measurable disease as defined by RECIST criteria. 5. Patients must have recovered from any therapy-related toxicities from previous chemo-, immuno-, or radiotherapies to CTC smaller or equal to Grade 1. 6. Patients must have recovered from previous surgery. 7. Life expectancy of at least three (3) months. 8. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0 or 1.
* Patients must be eighteen (18) years of age or older. 10. Willingness and ability to give written informed consent consistent with ICH-GCP guidelines.
Exclusion criteria:
* Progressive disease within 3 months after completion of curative intent treatment for localized/locoregionally advanced disease.* Prior use of an EGFR or erbB2 inhibitor in the recurrent/metastatic disease setting (treatment with cetuximab (Erbitux®) or other EGFR inhibitor during radiotherapy or chemoradiotherapy is permissible).* More than 2 chemotherapeutic regimens given for recurrent/metastatic disease.* Treatment with other investigational drugs, other anti-cancer-therapy (e.g., chemotherapy, immunotherapy, radiotherapy), concomitantly with therapy on this study and/or during the last four weeks, prior to the first treatment with the trial drug* eliminated per Amendment #1* Patients with history of other malignancy (except for appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least 3 years.* Patients with history of decompensated heart failure.* Cardiac left ventricular function with resting ejection fraction <50% or less than the institutional lower limit of normal by MUGA or echocardiogram.* Active infectious disease.* Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea.* Serious illness, concomitant non-oncological disease or mental problems considered by the investigator to be incompatible with the protocol.* Use of alcohol or drugs incompatible with patient participation in the study in the investigator's opinion.* Patients unable to comply with the protocol.* Patients with active/symptomatic brain metastases. Patients with a history of treated brain metastases must have stable or normal cerebral MRI scan at screening and be at least three months post-radiation or surgery.* Absolute neutrophile count (ANC) less than 1000/mm3.* Platelet count less than 75,000/mm3.* Bilirubin greater than 1.5 mg/dl/ Higher bilirubin values are acceptable for patients with known Gilbert's disease, approval by the PI and sponsor necessary.* Asparate amino transferase (AST) or alanine amino transferase (ALT) greater than 3 times the upper limit of normal.* Serum creatinine greater than 1.5 X upper limit of normal for the institution.* Patients who are sexually active and unwilling to use a medically acceptable method of contraception.* Pregnancy or breast-feeding.* Patients with known pre-existing interstitial lung disease. | 9,661 |
Study Objectives
This pilot phase I trial studies freeze-dried black raspberries in treating patients with oral squamous cell cancer undergoing surgery. Chemoprevention is the use of certain drugs to keep cancer from forming. Eating freeze-dried black raspberries may help prevent or treat oral cancer
Conditions: Squamous Cell Carcinoma of Mouth
Intervention / Treatment:
OTHER: laboratory biomarker analysis, OTHER: preventative dietary intervention
| Inclusion Criteria:
* Patients with newly diagnosed, biopsy-proven previously untreated squamous cell carcinoma (SCC) of the oral cavity (stages I - IV); suspected cases of SCC will be allowed if biopsy is performed and results of SCC confirmed on subsequent histopathologic analysis (i.e. frozen section) prior to enrollment and initiation of LBR administration
* Patients must already be planned for surgical resection of their tumor (prior to being considered eligible for this study)
* Patients must be able to take nutrition/medications orally
* No prior history of intolerance or allergy to berry or berry-containing products
Exclusion Criteria:
* History of intolerance (including hypersensitivity or allergy) to berry or berry-containing products
* Known history of bleeding disorder or patient on systemic anticoagulation therapy (i.e. coumadin, heparin) for purposes of the study biopsy
* Pregnant women; although there are no known adverse effects of black raspberries upon the fetus, if patients become pregnant during period of LBR administration, then LBR will be discontinued and patient will be removed from the study
* Inability to grant informed consent
* Patients must not be planning to receive chemotherapy or radiation therapy prior to their surgery or this will affect endpoint analysis and these patients will be excluded from the study
* Patients taking cyclooxygenase (COX)-I or COX-2 inhibitors, who cannot be taken off the medication due to their clinical condition will be excluded given that these agents may interfere with biomarkers studied
* Vegetarians will be excluded from the study since we anticipate that this patient population will have difficulty adhering to a low-phenolic diet (restricts basically all plant-based foods) | 18,115 |
Study Objectives
Cancer of the esophagus is a very serious cancer. Studies have shown that using chemotherapy and radiation before surgery is the most promising treatment approach, with one quarter to one half of tumors shrinking by 50% or more in size after chemotherapy and radiation. In patients who have a very good response to this treatment, survival following esophagectomy has increased, although the amount of increase has varied quite a bit between the different studies. Older studies have used the drugs Cisplatin and 5-fluoruracil. Although this combination of drugs has been beneficial, we wish to use a newer combination of drugs which may be more effective for esophageal cancer. The chemotherapy drugs used in this study are Cisplatin and Irinotecan. We also want to find out what side effects these drugs cause when given with radiation, and how often these side effects occur.
Conditions: Esophageal Cancer
Intervention / Treatment:
DRUG: Irinotecan hydrochloride trihydrate, DRUG: Cisplatin
| Inclusion Criteria:
* Histologically proven squamous or adenocarcinoma or the esophagus >20 cm from the incisors, including GE junction tumors (unless of gastric origin). GE junction tumors are defined as tumors that have their center within 5 cm proximal and distal of the anatomical cardia
* Clinical T1 N1 M0, T2-3 N0-1 M0, T1-3 N0-1 M1a
* Performance status ECOG 0-2
* Medically fit for chemotherapy, radiation and esophagectomy
* Adequate bone marrow, hepatic and renal function as evidenced by the following:
Hematology:
Neutrophils > 1.5 x 109/L Platelets > 100 x 109/L
Hepatic function:
Total bilirubin < 1.25x ULN AST (SGOT) and ALT (SGPT) < 2.5 x ULN Alkaline phosphatase <2.5 x ULN
Renal function:
Serum creatinine < 160 umol/L or creatinine clearance > 60 ml/min (actual or calculated by the Cockcroft-Gault method as follows):
weight (kg) x (140 - age) K x serum creatinine\*
* for serum creatinine in \*mol/L, K=0.814 in man, K=0.96 in woman
* No prior history of malignancy unless > 5 years disease free, or adequately treated nonmelanotic skin cancer or in situ carcinoma of the cervix
* Tumor technically resectable (as defined in Section 5.4.3)
Exclusion Criteria:
* In situ or clinical T1N0M0
* Cervical esophageal tumors (within 20 cm of the incisors)
* Positive cytology of the pleura, peritoneum or pericardium
* Supraclavicular lymph node involvement
* Invasion of tracheobronchial tree proven by bronchoscopy including but not limited to tracheo-esophageal fistula
* Prior treatment for this malignancy except esophageal stenting
* Gilbert's disease
* Age < 18
* Participation in another concurrent clinical study involving study drug(s) or treatment with study drug within thirty days prior to the treatment on this study. Concurrent treatment with other experimental drugs or anticancer therapy
* Known hypersensitivity to either of study drugs or to any of their excipients.
* Pregnant or lactating women. Men and women of reproductive potential (and women < 12 months after menopause) may not participate unless they have agreed to use an effective contraceptive method while on study
* Known or suspected alcohol or drug abuse
* Other serious or concurrent illnesses that may interfere with subject compliance, adequate informed consent, determination of causality of adverse events and which in the judgement of the Investigator, would make the patient inappropriate for entry into the study
* Life expectancy < 3 months
* Peripheral neuropathy > Grade 2 (using CTC Version 2)
* Patients receiving phenytoin or phenobarbital | 29,448 |
Study Objectives
A retrospective, multi-center, single-blind, pivotal trial to assess clinical equivalence with stage II and III advanced gastric cancer based on the 6th and 8th of the AJCC
Conditions: Gastric Cancer
Intervention / Treatment:
| Inclusion Criteria:
* Sample providers criteria
* Male and female adult patients aged 19 years or over
* Postoperative patients with gastric cancer invading the submucosal layer and having 3 or more lymph nodes metastasis or who with gastric cancer infiltration of muscularis propria and lymph node metastasis (stage II and III advanced gastric cancer patients, 8th of the AJCC)
* Patients who have not received neoadjuvant chemotherapy and radiotherapy
* Patients with pathological record and clinical information after surgery from archived FFPE(formalin-fixed paraffin-embedded) samples between 2005 and 2010
* Patients who have not been included in discovery clinical trial and confirmatory clinical trial
* Patients who have undergone a radical gastrectomy and who show no evidence of residual tumors as observed with the unaided eye or through a microscope* Sample criteria
* The FFPE tumor specimens in storage have a tumor amount of at least 20% and therefore can be tested.
* The quantity (not less than 400ng) and quality (A260/280 of not less than 1.8) of RNA are sufficient for analysis.
Exclusion Criteria:
* Sample providers criteria
* Male and female patients aged less than 19 years
* Postoperative patients with gastric cancer invading the mucosa and submucosal layer and having less than 3 lymph nodes metastasis or who with gastric cancer infiltration of muscularis propria without lymph node metastasis (stage II and III advanced gastric cancer patients, 8th of the AJCC)
* Patients who have received neoadjuvant chemotherapy or radiotherapy
* Patients without pathological record and clinical information after surgery from archived FFPE samples between 2005 and 2010
* Patients who have been included in discovery clinical trial and confirmatory clinical trial
* Patients with residual tumors after surgery* Sample criteria
* The FFPE tumor specimens in storage have a tumor amount of less than 20% and therefore cannot be tested
* The quantity and quality of RNA are not sufficient for analysis | 24,375 |
Study Objectives
The purpose of this study is to determine the recommended dose of the combination of AVE8062 with platinum salts (cisplatin or carboplatin) and taxanes (docetaxel or paclitaxel) in patients with advanced solid tumors for which platinum-taxane doublet constitutes mainstay of care.
Conditions: Neoplasms
Intervention / Treatment:
DRUG: OMBRABULIN (AVE8062)
| Inclusion Criteria:
* Advanced neoplastic disease (i.e. metastatic or locally advanced disease) for which platinum-taxane doublet regimens are approved or constitutes the mainstay of care such as non small cell lung cancer, epithelial ovary cancer, gastric cancer, transitional cell and bladder cancer and head and neck cancer.
* Eastern cooperative oncology group (ECOG) performance status of 0 to 1.
Exclusion Criteria:
* Concurrent treatment with any other anticancer therapy, including chemotherapy, immunotherapy, radiotherapy (excluding radiotherapy with palliative intent on non-target lesions), targeted therapy, gene therapy, or patients planning to receive these treatments during the study.
* Absence of histologically or cytologically proven cancer at the first diagnosis.
* Negative serum/urinary pregnancy test
* Washout period of 3 weeks for prior anti-tumor therapy or any investigational treatment
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. | 27,664 |
Study Objectives
The purpose of the study is to determine the safety and clinical benefit of the combinations of abiraterone acetate and prednisone or abiraterone and dexamethasone in prostate cancer patients. Prednisone will be given at one of three different dose schedules. Dexamethasone will be given at one dose schedule. This will include looking at what side effects occur and how often they occur. In addition the impact of the study drug on quality of life and pain will be evaluated. The study will also collect data on subsequent treatment of patients after they come off the study drug (approximately 4.5 years after the start of study treatment of the first subject participating in the study). By analyzing blood samples, the study aims to identify if some markers could help to understand if the treatment with abiraterone is effective and also help to understand if patients can become resistant.
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: Abiraterone Acetate, DRUG: Prednisone 5 mg twice daily, DRUG: Prednisone 5 mg once daily, DRUG: Prednisone 2.5 mg twice daily, DRUG: Dexamethasone 0.5 mg once daily
| Inclusion Criteria:
Have a histologically or cytologically confirmed adenocarcinoma of the prostate Have metastatic disease documented by positive bone scan or by computed tomography or magnetic resonance imaging Have prostate cancer progression documented by prostate specific antigen according to Prostate Cancer Working Group 2 or radiographic progression according to modified RECIST (response evaluation criteria in solid tumors, v1.1) criteria Be asymptomatic from prostate cancer. A score of 0-1 on BPI-SF Question #3 (worst pain in last 24 hours) will be considered asymptomatic Be surgically or medically castrated, with testosterone levels of <50 ng/dL (<2.0 nmol/L). If the subject is being treated with luteinizing hormone releasing hormone (LHRH) agonists or antagonists (subjects who have not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to Day 1, Cycle 1 and must be continued throughout the study.
Exclusion Criteria:
Has a history of pituitary or adrenal dysfunction Has an active infection or other medical condition that would contraindicate corticosteroid use Has any chronic medical condition requiring corticosteroid treatment or has received prior corticosteroid treatment for prostate cancer Has a pathological finding consistent with small cell carcinoma of the prostate Has a known brain metastasis | 13,290 |
Study Objectives
This study is a visual assessment of diagnostic PET/CT images obtained after a single intravenous injection of BAY85-8050 in patients with cancer
Conditions: Neoplasm
Intervention / Treatment:
DRUG: F-18 (BAY85-8050), DRUG: F-18 (BAY85-8050)
| Inclusion Criteria:
* Healthy volunteers only
* Males/females, >=50 and <= 65 years of age
* Cancer patients only
* Males/females >= 35 years and <= 75 years of age
* Patient had an FDG PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass
Exclusion Criteria:
* Concurrent severe and/or uncontrolled and/or unstable other medical disease (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY85-8050, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
* Known sensitivity to the study drug or components of the preparation | 18,362 |
Study Objectives
VOICE project aims to guide health services in their reorganization towards the provision of the highest value care for the patient at the best cost. VOICE is targeted to patients with breast and lung cancer. The purpose is to offer a new innovative strategic framework based on value-based healthcare model to these patients in Europe. VOICE Community consists of 13 hospitals across Europe working collaboratively to implement this approach.
The Community addresses what matters most to patients by measuring patient reported health outcomes in routine clinical practice on a systematic and long-term basis, by including patients´ perspective in clinical decision-making, improving patient empowerment and physician-patient communication, assessing the impact on costs of the processes implemented, identifying factors for a successful implementation of value-based healthcare and boosting knowledge generation and best practice exchange across Europe.
The VOICE ambition is to collect the health-related Quality of Life evidence from more than 1000 patients (patients with breast cancer and patients with lung cancer), by means of health related and patient reported questionnaires (ICHOM, International Consortium for Health Outcome Measurements, standard sets). Hospitals will go further by assessing the satisfaction, acceptability, relationship with professionals or decision-making process with patients.
The VOICE Community will benchmark health outcomes and related costs to improve care delivery of these patients.
Conditions: Breast Cancer, Lung Cancer
Intervention / Treatment:
OTHER: VOICE intervention
| Inclusion Criteria for patients with breast cancer:
* male and female over 18
* recently diagnosed with invasive stage I-IV cancer, or Ductal Carcinoma in Situ (DCIS)
* undergoing any treatment type (surgery, radiotherapy, chemotherapy, hormone therapy and/or targeted therapy).
Inclusion Criteria for patients with lung cancer:
* male and female over 18
* newly diagnosed with lung cancer
* eligible to receive curative or palliative care treatment.
Exclusion Criteria for patients with breast cancer:
* With rare tumours
* With Lobular Carcinoma In Situ (LCIS)
* With recurring illness | 26,374 |
Study Objectives
According to radiology imaging, the patients of HCC are divided into two groups(hypovascular tumor group and moderately vascular tumor group). Every group is divided into TACE therapy with balloon catheter subgroup and regular TACE therapy subgroup. Patients take the TACE therapy each 45 days, and have MRI diffusion examine or CT one week before next therapy. All objects are observed until the end event happening or in the group for 6 months.
Conditions: Hepatocellular Carcinoma
Intervention / Treatment:
PROCEDURE: balloon catheter
| Inclusion Criteria:
* sign the written informed consent form provided.
* diagnosed clinically as HCC,need to take TACE.
Exclusion Criteria:
* have had an allergic reaction following iodine.
* have been in any TACE or radiotherapy or biotherapy within 30 days before the study.
* HCC of diffuse type,failure of hepatic function, chronic illness or disease including failure of heart function, uncontrolled high blood pressure, heart disorders, serious infection, uncontrolled diabetes mellitus. | 7,785 |
Study Objectives
The purpose of this phase 1b/2 study is to estimate the treatment effect of study drug measuring progression free survival.
Conditions: Non Small Cell Lung Cancer
Intervention / Treatment:
DRUG: AMG 386, DRUG: AMG 386, DRUG: AMG 386 Placebo, DRUG: Pemetrexed, DRUG: Carboplatin
| Inclusion Criteria:
* Histologically confirmed, unresectable stage IV non-squamous non small cell lung cancer (NSCLC)
* Radiographically evaluable disease (measurable or non-measurable) per RECIST 1.1 with modifications
* Adequate hematological, renal, and hepatic function, normal coagulation profile, calculated CrCL ≥ 45 mL/min
* Other criteria may apply
Exclusion Criteria:
* Any prior chemotherapy or targeted therapy for non-squamous NSCLC
* Subjects with adenosquamous histology or any histology subtype containing greater than 10% squamous cells
* Subjects with an epidermal growth factor receptor (EGFR) mutation sensitive to treatment with a tyrosine kinase inhibitor (TKI)
* Subjects with known anaplastic lymphoma kinase (EML4-ALK) translocations
* History or presence of central nervous system metastases
* Central (chest) radiation therapy within 28 days prior to enrollment/randomization, radiation therapy to any other site(s) within 14 days prior to enrollment/randomization
* History of pulmonary hemorrhage or gross hemoptysis within 6 months
* History of arterial or venous thromboembolism within 12 months
* History of clinically significant bleeding within 6 months
* Clinically significant cardiovascular disease within 12 months
* Other criteria may apply | 38,272 |
Study Objectives
To determine the maximum tolerated dose or optimal biological dose, and the safety profile of MEDI3617 when given as a single-agent or in combination with other chemotherapeutic agents in subjects with advanced solid malignancies resistant to standard therapy.
Conditions: Advanced Solid Tumors, Advanced Recurrent Ovarian Tumors
Intervention / Treatment:
DRUG: MEDI3617, DRUG: Bevacizumab, DRUG: Paclitaxel, DRUG: Carboplatin
| Inclusion Criteria:
* Patients with confirmed diagnosis of advanced solid tumors (dose-escalation phase) or another solid tumor type based on antitumoral activity (dose-expansion phase) that are not responsive to standard therapy or for which no standard therapy exists
* Patients must be 18 years of age or older
* Karnofsky Performance Status ≥ 70
* Toxicities from previous cancer therapies must have recovered to CTCAE Grade = or < 2
* Adequate organ and marrow function
* Using adequate contraceptive measures, be surgically sterile or post-menopausal
Exclusion Criteria:
* Concurrently enrolled in another clinical study, except for non-interventiona observational studies, or if in a follow up period from a previous study
* Receipt of any investigational anticancer therapy within 30 days prior to the first dose of MEDI3617, or in the case of monoclonal antibodies (eg, bevacizumab), 42 days prior to the first dose of MEDI3617
* Current or previous treatment with angiopoietin inhibitors, or inhibitors of Tie1 or Tie2 including, but not limited to, AMG386, CVX-060, XL880, and XL820
* Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment
* Use of immunosuppressive medication or systemic steroids within 7 days prior to first dose of MEDI3617
* Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
* Known bleeding diathesis
* Pulmonary hemorrhage or gross hemoptysis within 6 months prior to enrollment
* Therapeutic or palliative radiation therapy within 2 weeks prior to enrollment | 33,107 |
Study Objectives
The purpose of the study is to assess the effect of Sunitinib on tumor vascularization and necrosis in patients with metastatic renal cell cancer.
Conditions: Renal Cell Cancer
Intervention / Treatment:
| Inclusion Criteria:
* patients with metastatic renal cell cancer for whom treatment with Sunitinib is planned
* histologically verified stage IV renal cell carcinoma of clear cell type
* measurable primary tumor or metastases (minimal diameter 2 cm) at other sites than the lungs
* Karnofsky score > 70%
* age > 18 year.
* written informed consent
Exclusion Criteria:
* contra-indications for MRI
* contra-indications for treatment with Sunitinib
* previous systemic treatment within the last 30 days | 5,218 |
Study Objectives
The purpose of this study is to compare the 16/8 intermittent fasting method with the 5:2 Method in a subset of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma at BC Cancer- Victoria. The purpose is to find out which is the preferred method by patients and which has the greatest effect on:
* cancer cells (lymphyocyte count),
* metabolism (autophagy activation),
* inflammation (CRP),
* gut microbiome (metabolomic analysis).
Participants will have already completed our previous trial, "Intermittent Fasting in CLL/SLL" (ClinicalTrials.gov Identifier: NCT04626843) where they followed the 16/8 Fasting Method followed by a minimum of a 3 months washout period, and will now follow the 5:2 Method for 90 days. The same samples and outcome measures will be collected in order to directly compare the two diets in the same patient cohort.
Conditions: Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)
Intervention / Treatment:
BEHAVIORAL: 5:2 Method (intermittent fasting regimen), BEHAVIORAL: 16/8 Method (intermittent fast regimen)
| Inclusion Criteria:
* Diagnosis of CLL or SLL
* Age < 85 years
* Peripheral blood lymphocytes >20 x 109/L
* Hemoglobin > 90g/L
* Platelets > 90 x 10\*9/L
* BMI of >=20kg/m2
* ECOG Performance Status >=2
* Completion of "IF in CLL/SLL Study" (ClinicalTrials.gov Identifier: NCT04626843) followed by minimum of 3 month ad libitum eating
Exclusion Criteria:
* Patient unable to give consent
* Patient on medications required to be taken with food during the fasting window
* Pregnancy
* Diabetes mellitus
* BMI drop to < 18.5kg/m2 at any time during study
* Anti-lymphoma therapy within the past 3 months
* Expected to require initiation of anti-lymphoma therapy within the next 3 months | 17,590 |
Study Objectives
Brain metastases occur when cancer cells from the initial tumour site (for example, lung or breast) spread to the brain. This develops in approximately 10% - 30% of adults with cancer. They can produce different complaints related to their effect on brain functioning, decrease in a person's ability to carry on with their usual activities, a reduction in the quality of life and shortened life expectancy.
The standard treatment particularly for people with more than one brain metastasis consists of palliative radiation therapy to the brain and steroids. Steroids (such as Decadron or Dexamethasone) are medication used to reduce swelling around the tumour, and thus symptoms improve. Steroids could be very helpful but have a number of potential side effects, particularly if used for longer periods of time. There is no standard dose of Decadron used in treating brain metastases patients. The most commonly dose used is 4 mg four times/day.
This study will assess if lower doses of Decadron - 8 mg every morning for symptomatic patients and 4 mg every morning for asymptomatic patients - are effective in maintaining symptom control in patients with brain metastases, without neurological deterioration that necessitates the patient to go back or to a higher dose at any time. This information will help also in understanding how to decrease the side effects associated with higher doses of steroids in people with your condition.
Conditions: Neoplasm Metastasis
Intervention / Treatment:
DRUG: dexamethasone
| Inclusion Criteria:
* Known diagnosis of cancer (even if primary unknown)
* Brain metastases (single or multiple) confirmed by imaging (CT, MRI)
* No contraindication for RT/steroids
* Patient will be treated with Whole Brain Radiation Therapy
* Informed consent
Exclusion Criteria:
* Primary cancer is lymphoma or leukemia
* Complete surgical excision of brain metastases
* Patient was on steroids for more then 2 weeks prior to entering the study
* Confusion or other factors that would impair ability to assess symptoms | 8,020 |
Study Objectives
Colonoscopy is a sedated procedure traditionally performed using air insufflation during the insertion phase of the procedure. Recently, the use of water method (eg, water infusion or water exchange techniques) during the insertion phase of colonoscopy has been reported to increase the proportion of patients in whom complete unsedated colonoscopy could be achieved, reduce patient recovery time burdens, decrease abdominal discomfort during and after colonoscopy, enhance cecal intubation, and increase willingness to repeat an unsedated colonoscopy. However, there has been no study on the use of water method during the training of primary care doctors or nurse endoscopists in flexible sigmoidoscopy for colorectal cancer screening.
In unsedated endoscopic procedure such as FS, endoscope insertion techniques that can potentially reduce patient discomfort and increase the rate of achieving an adequate depth of scope insertion are desirable. Our current study aims to evaluate the impact of water method during insertion phase of FS in the training of primary care doctors or nurse endoscopists for colorectal cancer screening.
Conditions: Colorectal Cancer Screening
Intervention / Treatment:
DIAGNOSTIC_TEST: Water method group, DIAGNOSTIC_TEST: Air insufflation group
| Inclusion Criteria:
* Consecutive asymptomatic patients suitable for CRC screening by FS
* Age 50 - 70 years
* Written informed consent available
Exclusion Criteria:
* Contraindications for endoscopy due to comorbidities
* Unable to provide written informed consent
* Personal history of polyposis syndrome, personal history of CRC, personal history of inflammatory bowel disease
* Coagulopathy (INR>1.5) or thrombocytopenia (platelets <50,000)
* Pregnant patients | 31,817 |
Study Objectives
Patient-reported information on outcomes such as symptom-burden and health-related quality of life (QoL) is regarded as a useful tool to improve quality of care in clinical cancer research. However, integrating patient-reported information in the routine clinical practice is often difficult due to excessive time use and practical barriers. Electronic data acquisitions, where the treating physician has immediately access to the patient-reported data in the subsequent consultation, have been shown to be beneficial in the everyday clinical decision making.
The aim of this study is to develop and test a computer-based patient-reported assessment tool that will assist the clinicians in tracking long term and late effects in head and neck cancer patients and investigate if the tool leads to improved symptom assessment of a range of head and neck cancer specific symptoms, which again may lead to improved symptom control and enhanced quality of life in the patients.
Patients with a diagnosis of head and neck cancer attending the oncology outpatient clinics at Herlev Hospital and physicians and nurses who work at the clinic will be invited to participate. The assessment tool will be developed with inspiration from prior international studies of symptom assessment in head and neck cancer patients and tailored so that it will fit into a Danish context. The tool will be tested in a controlled intervention study. In the intervention group, patients will complete the assessment tool in the patients waiting area prior to every scheduled consultation. The result will then be printed and provided to the treating physician. In the control group, the patients will complete the assessment tool prior to consultations. However, the data will not be provided to the physicians at any time.
To assess the impact of the tool on number of symptoms addressed during consultations and patients' overall quality of life, medical records will be reviewed for before start of intervention and again at 6 and 12 months follow-up. The patients will also complete the EORTC QLQ-C30 and the EORTC QLQ-H\&N35 at baseline and at 6 and 12 months follow-up. Furthermore, we will conduct a qualitative evaluation (semi structured interview and participant observations) of attitudes among clinicians and patients regarding the use of tool at the point of care.
Conditions: Head and Neck Cancer Patients, Late Effects
Intervention / Treatment:
BEHAVIORAL: WebCan
| Inclusion Criteria:
* Prevalent recurrence free patients with cancers in the tongue, oral cavity, pharynx and larynx attending the oncology clinic at Herlev Hospital, Herlev, Denmark. 9 months to 5 years after end of treatment
Exclusion Criteria:
* Patients with recurrence of their cancers and patients still in treatment. | 35,059 |
Study Objectives
The main purpose of this observational study with Oxaliplatin onkovis is to determine the number of treatment cycles and the quantity of Oxaliplatin onkovis needed for this purpose under the special circumstances of ambulant chemotherapy.
Onkovis aims to contribute to an economical utilization of the chemotherapeutics. This includes provision of appropriate packaging sizes to decrease the excess quantity to be discarded, and thus also follows this objective.
Secondary objective is the assessment of the side effects of Oxaliplatin onkovis. To this end, data regarding co-medication and adverse events are also collected.
Conditions: Carcinoma
Intervention / Treatment:
| Inclusion Criteria:
* Indication for Oxaliplatin according to the Summary of Product Characteristics (SmPC) and treating physician
Exclusion Criteria:
* According to the Oxaliplatin SmPC | 24,822 |
Study Objectives
The aim of the proposed study is to understand the palliative care needs of patients with pancreatic cancer, to investigate whether early palliative care can improve patient outcomes and reduce use of health care services, and to understand the psychological health of carers and their satisfaction with care.
A quasi-experimental design is used, introducing palliative care for patients with pancreatic cancer within three weeks from diagnosis. The patients are recruited in Dept. of Surgery, Hospital of North Zealand, which covers the northern catchment area of the Capital Region of Copenhagen, Denmark. Patients are seen by the palliative care team on home-visits every four weeks throughout their trajectory, and quality of life is evaluated using the following quality of life questionnaires (QLQs): European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer Patients receiving palliative care (EORTC QLQ-C15-PAL), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Pancreatic Cancer Patients (EORTC QLQ-PAN26), and Hospital Anxiety and Depression Scale (HADS). For carers, mental health is evaluated using HADS and satisfaction with care is evaluated using the Family Caregivers' Satisfaction With Palliative Care in Advanced Cancer Questionnaire (FAMCARE-2).
The primary outcome is health care service use (acute hospital admissions, days in hospital). Secondary outcomes are survival and place of death. Data are compared with historical control patients treated in the same hospital before introduction of early palliative care. These outcomes are readily available from patient records and are expected to carry a very low risk of bias.
Palliative care needs at referral in the study group will be compared with palliative care needs in the subgroup of historical control patients referred to palliative care on-demand.
For outcomes where unbiased historical control data are not available a prospective observational approach is used. These include symptom burden, weight, psychological health and satisfaction with care.
The minimum sample size needed to show a clinically significant decrease in acute hospital admissions is 70, 35 participating in the prospective study and 35 historical control patients. The study will include 40-50 patients and their carers from September 2019 to September 2020.
Conditions: Pancreatic Cancer
Intervention / Treatment:
OTHER: Palliative care
| Inclusion Criteria:
* Adults newly diagnosed with pancreatic cancer in Dept. of Surgery, Hospital of North Zealand, Denmark
* Caregivers involved in care or practical help
Exclusion Criteria:
* Inability to take an active part in answering questionnaires | 7,249 |
Study Objectives
The purpose of this study is to demonstrate a betterment of the digestive symptomatology by the anti-emetic acupression's bracelets's use associated with hygiene and dietetic advices.
Conditions: Breast Neoplasms
Intervention / Treatment:
DEVICE: Acupression's bracelet, BEHAVIORAL: Hygiene and dietetic advices
| Inclusion Criteria:
* Woman
* Age > 18 years
* Well-informed written consent, signed by the patient before the beginning of the study
* Breast cancer's diagnosis (operated or not)
* Forecast of a treatment by FEC100 chemotherapy's sort (D1=D21) during at least 3 cycles.
* Patient affiliated at a welfare or beneficiary from it
* Investigator estimates that the patient is able to conform with protocol's conditions and to respect them
Exclusion Criteria:
* Operated arm's lymphedema
* Wrist's morphology which cannot permit the bracelet's wearing (20 cm)
* D1=D15 FEC100's treatment
* Psychic incapability to sign a well-informed consent
* Refusal to give a written consent
* Patient under tutelage or guardianship
* Pregnant or breast-feeding woman
* Any clinical trial's participation which would impose nausea and vomiting's treatment modalities | 25,269 |
Study Objectives
This is a longitudinal, multicenter, prospective, pharmacoepidemiological study to evaluate progression free survival (PFS) in a real-life setting in participants with metastatic colorectal cancer (mCRC) starting chemotherapy combined with bevacizumab.
Conditions: Metastatic Colorectal Cancer
Intervention / Treatment:
OTHER: Observational Chemotherapy, DRUG: Concomitant Bevacizumab
| Inclusion Criteria:
* Having colon or rectal metastatic adenocarcinoma, for which the physician decided during the inclusion visit to start a treatment with bevacizumab combined with a 1st, 2nd or 3rd line chemotherapy
* Having received oral and written information about the survey and not objecting to having his/her data computerized
Exclusion Criteria:
* Participating in a clinical trial assessing an anticancer treatment | 38,327 |
Study Objectives
This pilot research trial studies the use of a human prostate tissue model to maintain and study prostate cancer stem cells. A human prostate tissue model uses leftover tissue that was removed during surgery from patients with non-cancerous enlargement of the prostate (benign prostatic hyperplasia) and may create an environment similar to the natural environment of the human body. Prostate cancer stem cells are cells that cause cancer to grow. Using real tissue to create an environment to study stem cells may help doctors learn more about how they work and how they respond to treatments.
Conditions: Benign Prostatic Hyperplasia, Prostate Carcinoma
Intervention / Treatment:
OTHER: Cytology Specimen Collection Procedure, OTHER: Laboratory Biomarker Analysis
| Inclusion Criteria:
* Male patients scheduled for a prostatectomy
* Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document
Exclusion Criteria:
* Patients with prostate involvement secondary and as a result of metastasis or spread of cancerous cells from other organs | 23,491 |
Study Objectives
This phase I trial is studying the side effects and best dose of decitabine when given together with doxorubicin and cyclophosphamide in treating children with relapsed or refractory solid tumors or neuroblastoma. Drugs used in chemotherapy, such as decitabine, doxorubicin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
Conditions: Recurrent Neuroblastoma, Unspecified Childhood Solid Tumor, Protocol Specific
Intervention / Treatment:
DRUG: decitabine, DRUG: doxorubicin hydrochloride, DRUG: cyclophosphamide, BIOLOGICAL: filgrastim, BIOLOGICAL: pegfilgrastim, OTHER: laboratory biomarker analysis, OTHER: pharmacological study
| Inclusion Criteria:
* Histologically confirmed diagnosis of either of the following:
* Solid tumor (part A)
* No lymphoma
* Neuroblastoma (part B)
* Original diagnosis may be based on elevated urine vanillylmandelic acid (VMA) and homovanillic acid (HVA) and bone marrow examination
* Accessible disease by bone marrow aspirate or tumor biopsy
* No laparotomy, thoracotomy, endoscopy, or craniotomy for biopsy
* No known curative therapy OR therapy proven to prolong survival with an acceptable quality of life available
* No known brain or spinal cord metastases
* No CNS tumors
* Performance status - Karnofsky 50-100% (patients 11 to 21 years of age)
* Performance status - Lansky 50-100% (patients ≤ 10 years of age)
* Parts A and B without bone marrow infiltration:
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3 (transfusion independent)
* Part B with bone marrow infiltration (i.e., tumor metastatic to bone marrow with granulocytopenia, anemia, and/or thrombocytopenia):
* Absolute neutrophil count ≥ 750/mm\^3
* Platelet count ≥ 50,000/mm\^3 (transfusion independent)
* Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
* No sickle cell anemia
* Bilirubin ≤ 1.5 mg/dL
* ALT ≤ 5 times upper limit of normal
* No significant hepatic dysfunction that would compromise the tolerability of decitabine or interfere with study procedures or results
* Creatinine based on age as follows:
* ≤ 0.8 mg/dL (5 years of age and under)
* ≤ 1.0 mg/dL (6 to 10 years of age)
* ≤ 1.2 mg/dL (11 to 15 years of age)
* ≤ 1.5 mg/dL (16 to 21 years of age)
* Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min
* No significant renal dysfunction that would compromise the tolerability of decitabine or interfere with study procedures or results
* Shortening fraction ≥ 28% by echocardiogram
* Ejection fraction of ≥ 45% by MUGA
* No significant pulmonary dysfunction that would compromise the tolerability of decitabine or interfere with study procedures or results
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior allergic reaction attributed to compounds of similar chemical or biological composition to agents used in this study
* No uncontrolled serious infection
* No significant end-organ dysfunction that would compromise the tolerability of decitabine or interfere with study procedures or results
* Recovered from prior immunotherapy
* At least 7 days since prior biologic therapy
* More than 1 week since prior growth factor therapy (2 weeks for pegfilgrastim)
* More than 2 weeks since prior epoetin alfa
* At least 6 months since prior autologous stem cell transplantation
* At least 6 months since prior allogeneic bone marrow transplantation
* Patients must have full organ recovery and no evidence of graft-versus-host disease
* No concurrent immunomodulating agents
* No concurrent immunotherapy
* No concurrent biologic therapy
* No concurrent epoetin alfa
* Recovered from prior chemotherapy
* More than 2 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)
* Prior total lifetime cumulative anthracycline dose ≤ 450 mg/m\^2 of doxorubicin or equivalent
* No other concurrent chemotherapy
* No concurrent hydroxyurea
* Recovered from prior radiotherapy
* More than 2 weeks since prior local palliative small port radiotherapy
* More than 6 months since prior substantial bone marrow irradiation (e.g., cranio-spinal irradiation, total body irradiation, or hemi-pelvic irradiation)
* No concurrent radiotherapy
* No other concurrent anticancer therapy
* No other concurrent investigational agents
* Concurrent oral iron supplementation for patients with a known iron deficiency or a microcytic hypochromic anemia allowed | 20,335 |
Study Objectives
The aim of the study is to evaluate the use of irreversible electroporation in the treatment of locally advanced cancers of the head of pancreas with vascular spread. This technique would allow to treat the unresectable part of the tumor to make it more accessible for a secondary surgery.
Conditions: Pancreatic Adenocarcinoma, Interventional Imaging
Intervention / Treatment:
DEVICE: NanoKnife
| Inclusion Criteria:
* Patients with histologically proven adenocarcinoma of the head of the pancreas (fine needle aspiration or biopsy)
* Pancreatic adenocarcinoma locally advanced on imaging at diagnosis
* Tumor of less than 7 cm in largest diameter
* No chemotherapy or abdominal radiotherapy within five years before the inclusion in the study
Exclusion Criteria:
* Pancreatic adenocarcinoma of more than 7 cm of diameter or immediately operable on imaging data
* Patient with contraindication of NanoKnife use
* Patient with neurostimulator
* Epileptic patient or with a myocardial infarction lasting less than 2 months
* Presence of visceral or lymph node metastases or peritoneal carcinosis at the initial workup
* Patient who cannot be treated with muscle blockers (curare)
* Patient with a metallic stent or a medical device implanted near the area treated by electroporation | 5,460 |
Study Objectives
The purpose of this study is to determine whether a brief couple-based supportive intervention effectively assists patients and their partners coping with the challenges of head and neck cancer.
Conditions: Head and Neck Cancer
Intervention / Treatment:
BEHAVIORAL: Couple-Based CBT Intervention
| Inclusion Criteria:
* Recently diagnosed with Head and Neck Cancer receiving chemotherapy and/or radiation therapy
* No history of cancer within past 3 years (other than basal cell)
* Living with partner in a committed relationship at least 6 months
* Patient and partner speak and read English
Exclusion Criteria:
* Serious cognitive or emotional issues that preclude full participation in study | 18,411 |
Study Objectives
An investigation on the difference in stoma hernia frequency related to surgical technique when incising the fascia. All patients planned for elective colostomy formation are to be included. Patients undergoing rectal resection with a TME and a colostomy (Hartmann's procedure) for rectal cancer, abdominoperineal resection for rectal cancer or diverting colostomy for any reason are all included.
The three groups for randomization are:
A. circular incision in the abdominal wall fascia B. cruciate incision in the abdominal wall fascia C. mesh enforced cruciate incision in the abdominal wall fascia Primary endpoint is the parastomal hernia rate within 12 months from index surgery. Secondary end-points include clinical variables, re-admission and/or re-operation due to any stoma complication, quality of life and health economy analyses, at 12 months.
Conditions: Colostomy, Colorectal Neoplasm, Diverticulitis
Intervention / Treatment:
PROCEDURE: Cruciate incision, PROCEDURE: Circular incision, OTHER: Mesh enforced cruciate incision
| Inclusion Criteria:
* presenting with a cancer or other conditions for which an elective surgical procedure is planned and includes a permanent colostomy formation
* possible to operate in regard to concomitant disease
* giving informed consent to participate
Exclusion Criteria:
* Not possible to operate due to concomitant disease
* Participation in other randomized trials in conflict with the protocol and end-points of the Stoma-Const trial. | 10,493 |
Study Objectives
Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Phase II trial to study the effectiveness of lapatinib in treating patients who have recurrent or metastatic prostate cancer.
Conditions: Recurrent Prostate Cancer, Stage IV Prostate Cancer
Intervention / Treatment:
DRUG: lapatinib ditosylate, OTHER: laboratory biomarker analysis
| Inclusion Criteria:
* Patients must have histologically or cytologically confirmed prostate cancer that is recurrent after local therapy, and/or metastatic carcinoma confirmed to be of prostate origin
* Patients must have recurrent and/or metastatic disease that is progressive and not amenable to surgery or curative radiotherapy; progressive disease is defined as:
* Three consecutive rising PSAs, at least 4 weeks apart with an absolute increase of at least 0.5
* PSA doubling time of less than one year
* PSA > 2.0
* For recurrent disease following local therapy (surgery/radiation), prior neoadjuvant or adjuvant hormones are allowed if completed more than a year prior to study entry; for metastatic disease, no prior medical therapy (hormonal, corticosteroid, chemotherapy) is allowed
* Life expectancy of greater than 12 weeks
* ECOG performance status 0,1, or 2
* Leukocytes >= 3,000/uL
* Absolute neutrophil count >= 1,500/uL
* Platelets >= 100,000/uL
* Total bilirubin within normal institutional limits
* AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal
* Creatinine within normal institutional limits or creatinine clearance >= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
* Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan; note that baseline and on treatment scans should be performed using the same modality and preferably at the same institution
* Must be willing and able to undergo tumor biopsy once before (if no previous specimen available) and once during investigational therapy if there are lesions accessible for biopsy for correlative studies; in cases where there is a medical contraindication to tumor biopsy, exception may be granted only upon discussion with the principal investigator
* Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of GW572016 will be determined following review of their use by the principal investigator
* Patients requiring oral anticoagulants (coumadin, warfarin) are eligible provided there is increased vigilance with respect to monitoring INR
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or 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
* Able to swallow and retain oral medication
Exclusion Criteria:
* Prior treatment:
* Patients who have had prior chemotherapy for prostate cancer
* Patients who have been on androgen ablative therapies within the last year
* Patients receiving radiotherapy to the prostate less than 6 weeks prior to study entry
* Patients who have had prior treatment with EGFR targeting therapies
* Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier
* Patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy
* Patients with a history of other active malignancy in the past 5 years (with the exception of adequately treated non-melanomatous skin cancers) are excluded
* History of allergic reactions attributed to compounds of similar chemical or biological composition to GW572016
* 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
* Patients with cardiac ejection fraction, not within the institutional range of normal as measured by echocardiogram or MUGA scan at baseline
* Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)
* Concomitant requirement for medication classified as CYP3A4 inducer or inhibitor | 2,331 |
Study Objectives
This protocol is an open label, single arm, non-randomized, phase I / II clinical trial investigating the use of pegylated interferon alpha-2a (peg-IFN-α, Pegasys®, Genentech) for prevention of relapse in acute myeloid leukemia (AML) not in remission at the time of allogeneic hematopoietic stem cell transplantation (HCT).
Conditions: Acute Myeloid Leukemia
Intervention / Treatment:
DRUG: peg-IFN-α, PROCEDURE: Hematopoietic Cell Transplant (HCT), DRUG: Tacrolimus, DRUG: Methotrexate
| Inclusion Criteria:
* Patient must have AML not in remission or at very high risk for HCT (Hematopoietic Cell Transplantation) relapse.
* For newly diagnosed AML, patients must have achieved two consecutive induction attempts without achieving complete remission
* For patients initially in complete remission whose AML relapses > 6 months after preceding remission, one re-induction must be attempted to be eligible
* For AML patients with early relapse, in whom the preceding remission is shorter than 6 months duration, no re-induction regimen is necessary to be eligible
* Patients with antecedent MDS (Myelodysplastic Syndrome) who progress to AML may have therapies rendered during both phases counted towards these requirements.
* Patients with poor cytogenetic or molecular risk associated with very high risk for relapse after HCT may proceed without provisions for prior treatment. However, they must have received at least one induction attempt.
* Patients must be ≥ 18 years of age and considered a candidate for HCT
* Karnofsky ≥ 70% (Karnofsky performance status is measure of a cancer patients general well being and activities of daily life. Scores range from 100 to 0 where 100 is perfect health and 0 is death
* Patients must meet acceptable organ function criteria: Total Bilirubin ≤2.5 mg%; AST (Aspartate transaminase) and ALT (Alanine transaminase) <5.0 X institutional upper limit of normal; GFR (Glomerular filtration rate) >40 mL/min/1.73 m2 for patients with creatinine levels above institutional normal; Lung function tests (DLCO, FEV1, FVC) > 50%; Ejection fraction > 50%
* All patients must sign an informed consent
* Women and men of child-bearing potential must agree to use adequate contraception
Exclusion Criteria:
* Prior chemotherapy treatment for AML within 21 days from the initiation of HCT conditioning
* Patients may NOT have evidence or symptoms of CNS disease at the time of enrollment
* HIV or HTLV1 / HTLV2 (Human T-lymphotrophic virus) (seropositivity and/or PCR positivity)
* Patients less than 18 years of age
* Pregnant and nursing mothers are excluded from this study
* Patients with untreated or uncontrolled neuropsychiatric illness
* Any physical or psychological condition that, in the opinion of the investigator, would pose unacceptable risk to the patient
* Uncontrolled infections | 11,300 |
Study Objectives
The purpose of this study is to develop a test for detection of pancreatic cancer by looking at the subject's DNA.
Conditions: Pancreatic Cancer
Intervention / Treatment:
DRUG: Synthetic Human Secretin
| Inclusion Criteria:
* Patients who are referred for the evaluation of pancreas cancer, pancreatic cystic neoplasm, and family history of pancreas cancer.
* International normalized ratio (INR) less than 1.5
* Platelet count >50,000
Exclusion Criteria:
* Any medical condition that preclude the patient from having a therapeutic procedure regardless of the Endoscopic ultrasound (EUS) finding
* Pregnant patients | 30,369 |
Study Objectives
The purpose of this study is to assess the efficacy of post-operative high-dose bolus interleukin-2 (IL-2) in patients with high-risk renal cell carcinoma (RCC).
Conditions: Kidney Cancer
Intervention / Treatment:
DRUG: Interleukin-2
| Inclusion Criteria
* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate organ function as defined by a white blood cell (WBC) count of 4,000/L; a platelet count of 100,000/L; a Hemoglobin level of 10 g/dL; a serum creatinine of 1.5 mg/dL or creatinine clearance of 60 mL/min; and a direct bilirubin level of 1.5 mg/dL.
* Forced expiratory volume at 1 second more than 2.0 L or 75% of predicted for height and age from pre-enrollment pulmonary function testing.
* No history or evidence of cardiac disease on ECG
* No prior systemic treatment for RCC, but patients may have received prior locoregional radiation therapy to solitary resectable metastases, which must have undergone surgical resection before enrollment.
* No prior history of invasive malignancy in the past 5 years
* Human immunodeficiency virus (HIV) negative
* Female patients must not be pregnant or planning to become pregnant
Exclusion criteria
* Age younger than 16 | 26,030 |
Study Objectives
This is a single institution study of combining decitabine with fludarabine and busulfan in the setting of allogeneic stem cell transplantation. A study population of 20 subjects will be enrolled from The John Theurer Cancer Center at Hackensack University Medical Center. Subjects who are eligible to receive allogeneic hematopoietic stem cell transplantation according to the eligibility criteria will be consented and enrolled. Subjects will receive treatment with decitabine followed by reduced intensity fludarabine and busulfan prior to allogeneic stem cell transplantation. Subjects will be followed until 1 year post transplantation to assess stability of engraftment, toxicity, progression free survival, and disease response
Conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome
Intervention / Treatment:
DRUG: Decitabine plus Fludarabine and Busulfan
| Inclusion Criteria:
* Diagnosis of acute myelogenous leukemia or myelodysplastic syndrome being considered for transplantation.
* Age 45 to 80 years or < 45 with co-morbidity including: disease not in remission
* No uncontrolled infections.
* Patients shall have a 6/6 HLA-compatible related donor or an 8/8 -HLA-compatible unrelated donor.
* KPS 70-100%
* Creatinine < 1.6 X ULN (unless age < 45 yrs)
* Serum Bilirubin < 2.5 X ULN
* Capable of giving informed consent and have signed the informed consent form.
* Cardiac EF > 50% or cardiac clearance
* Pulmonary DLCO > 50% or pulmonary clearance
Exclusion Criteria:
* Untreated CNS leukemia
* Active hepatitis or other untreated infections | 29,158 |
Study Objectives
This study hypothesizes that more adenomas will be detected using the ENDO-AID assisted Colonoscopy compared to conventional colonoscopy.
A single-centre, randomized, same-day, back-to-back tandem colonoscopy trial comparing Adenoma Missed Rate and Adenoma Detection Rate in ENDO-AID assisted colonoscopy and conventional colonoscopy.
Conditions: Colorectal Neoplasms
Intervention / Treatment:
DIAGNOSTIC_TEST: ENDO-AID CADe assisted Colonoscopy
| Inclusion Criteria:
* Patients aged 18years or above
* Referred to endoscopy unit for diagnostic or surveillance colonoscopy
Exclusion Criteria:
* Familial history of Familial adenomatous polyposis / Hereditary non-polyposis colorectal cancer
* Known history of inflammatory bowel disease
* Known colitis or suspicion of colitis (inflammatory bowel disease, diverticulitis, infective colitis)
* Emergency endoscopy of any nature (eg gastrointestinal bleeding, colonic decompression)
* Previous incomplete colonoscopy (not including insufficient preparation) / difficult colonoscopy
* Patients referred for a therapeutic procedure or assessment of a known non-resected lesion
* Patients with known palliative colorectal malignancy
* Patient with coagulopathy
* Patient with colostomy
* Patient with multiple co-morbidities (American Society of Anaesthesiologist >3)
* Inability to give informed consent | 14,675 |
Study Objectives
This pilot clinical trial studies how well comic art creation works as supportive care in cancer patients and caregivers. Participating in a comic art creation workshop may help patients and their family members or friends share their medical experience through storytelling and drawings in a way that can, but does not have to, reflect the real world. It may also help improve emotional wellbeing and communication in cancer patients and caregivers.
Conditions: Caregiver, Malignant Neoplasm
Intervention / Treatment:
PROCEDURE: Art Therapy, OTHER: Interview, PROCEDURE: Quality-of-Life Assessment, OTHER: Questionnaire Administration
| Inclusion Criteria:
* Documented written informed consent of the participant
* Workshop A (2017 - 10 weeks- City of Hope)
* Either one of the following:
* City of Hope (COH) cancer patient (all types and at any time point of their disease) OR
* Caretaker/friend family member of the cancer patient
* Workshops B and C (2018 - 5 weeks - City of Hope)
* Cancer patients (all types and at any time point in their disease)
* Note: documentation to confirm this eligibility criteria will not be requested; self-reporting as a cancer patient will be considered adequate
* Ability read and speak English
* Willingness and ability to complete the entire workshop, including the interviews and questionnaires (there is no predetermined qualification with regard to the ability to hold an artist tool; accommodations and creative solutions will be made to facilitate participation) | 18,797 |
Study Objectives
Oral mucositis (OM) is recognized as one of the most frequent debilitating sequela encountered by head and neck cancer (HNC) patients treated by radiotherapy. The objective of the study is to assess primarily the effect of topical oral Omega-3 hydrogel in prevention of radiation-induced oral mucositis and secondarily, to test the effect of topical oral Omega-3 hydrogel on oral microbiome.
Conditions: Mucositis Oral
Intervention / Treatment:
DRUG: topical oral Omega-3 hydrogel, DRUG: conventional preventive treatment
| Inclusion Criteria:
* Patients who are going to receive radiotherapy as a treatment of head and neck cancer either as postoperative (adjuvant) therapy or definitive therapy.* Patients whose radiotherapy treatment planned dose is 50 Gy or above* Males and females with an age not less than 18 years* Patients receiving radiotherapy alone or receiving concomitant cisplatin (or carboplatin) with radiotherapy.
Exclusion Criteria:
* Patients under Anticoagulants such as warfarin, heparin, or aspirin.* Patients suffering from any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)* Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure. | 11,594 |
Study Objectives
The goal of this clinical trial is to study the effects of Immersive Virtual Reality in patients with cancer undergoing chemotherapy.
The main questions it aims to answer are:
* Could the immersive virtual reality application prevents or reduces anxiety, prevents or reduces fatigue, prevents or reduces pain, improves therapeutic adherence, prevents or reduces adverse events, then cancer patients treated with narrative medicine, and then cancer patients in standard care only?
* Could the immersive virtual reality application show symptoms of cybersickness?
Participants will be randomly allocated with balanced allocation ratio 1: 1: 1 into three groups: 1) Virtual Reality group; 2) Narrative medicine group; 3) Standard care group.
In the virtual reality arm, patients will use a Virtual Reality headset. The multimedia contents in VR, will have a video quality from 4K to 8K, 360 degrees, and High Definition audio stereo.
In control arm, patients will be free to choose different activities during the infusion of chemotherapy, such as conversation with nurses, doctors, trainees, reading, writing, watching television, listening to music or videos on their smartphone.
In narrative medicine arm, patients will express their subjective experience regarding to the chemotherapy through writing. The experience will be written in free form by the patient and will cover both the cognitive, emotional and perceptual aspects. A nurse will always be available to guide the patient in the activity of expressing cognitive, emotional and perceptual contents.
Researchers will compare the Virtual Reality group, Narrative Medicine group, Standard care group, to see the effects regarding to anxiety, fatigue, pain, improves therapeutic adherence and adverse events.
Conditions: Cancer, Chemotherapy Effect, Anxiety, Fatigue, Pain
Intervention / Treatment:
DEVICE: Virtual Reality
| Inclusion Criteria:
* age> 18 years;
* diagnosis of cancer with indication for intravenous chemotherapy;
* cognitively able to participate;
* no significant acoustic deficit;
* no significant visual impairment;
* sufficient ability to write and read in Italian.
Exclusion Criteria:
* use of antipsychotic drugs;
* epilepsy;
* use of drugs or alcohol;
* metastatic cancer. | 34,014 |
Study Objectives
This is a study evaluating the safety and efficacy of the monoclonal antibody olaratumab plus mitoxantrone plus prednisone compared to mitoxantrone plus prednisone in metastatic castration-refractory prostate cancer following disease progression or intolerance on docetaxel-based chemotherapy.
Conditions: Prostate Cancer
Intervention / Treatment:
BIOLOGICAL: Olaratumab, DRUG: Mitoxantrone, DRUG: Prednisone
| Inclusion Criteria:
* histologically-confirmed adenocarcinoma of the prostate
* radiographic evidence of metastatic prostate cancer (Stage M1 or D2)
* has prostate cancer unresponsive or refractory to medical or surgical castration with a serum testosterone level of <50 nanograms per milliliter (ng/mL)
* has had disease progression or intolerance on docetaxel-based therapy
* prostate-specific antigen (PSA) ≥10 ng/mL
* all clinically significant toxic effects of prior surgery, radiotherapy, chemotherapy or hormonal therapy have resolved to ≤Grade 1, based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.02
* participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
* adequate hematologic function
* adequate hepatic function
* adequate renal function
* urinary protein is ≤1 on dipstick or routine analysis
* life expectancy of more than 3 months
* fertile man with partners that are women of childbearing potential must use an adequate method of contraception during the study
* signed Informed Consent Document
Exclusion Criteria:
* concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or other noninvasive or in situ neoplasms
* The participant has received more than 1 prior cytotoxic chemotherapy regimen for metastatic disease
* prior therapy with mitoxantrone for advanced prostate cancer
* The participant has a history of symptomatic congestive heart failure or has a pre study echocardiogram or multigated acquisition scan with left ventricular ejection fraction that is ≥10% below the lower limit of normal institutional range
* history of prior treatment with other agents that directly inhibit platelet-derived growth factor (PDGF) or platelet-derived growth factor receptors (PDGFR)
* known allergy to any of the treatment components: olaratumab, mitoxantrone, and/or prednisone
* radiotherapy within 21 days prior to first dose of olaratumab
* any investigational therapy within 30 days of randomization
* is receiving corticosteroids at a dose >5 mg prednisone PO BID or equivalent
* received prior strontium-89, rhenium-186, rhenium-188, or samarium-153 radionucleotide therapy and has either ongoing evidence of bone marrow dysfunction or poorly controlled bone pain
* has any ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, psychiatric illness, active bleeding or pathological condition that carries a high risk of bleeding, or any other serious uncontrolled medical disorders
* known or suspected brain or leptomeningeal metastases
* known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness | 12,946 |
Study Objectives
The main objective of the CanMoRe study is to evaluate the impact of a standardized and individually adapted exercise intervention in Primary Health Care aiming at improving physical function (primary outcome) and habitual physical activity, health related quality of life, fatigue and psychological well-being in patients undergoing radical cystectomy due to urinary bladder cancer.
Conditions: Urinary Bladder Cancer
Intervention / Treatment:
OTHER: The CanMoRe programme, OTHER: Home exercise
| Inclusion Criteria:
* Patients who are planned for a robotic assisted laparoscopic radical cystectomy due to urinary bladder cancer at the Karolinska University Hospital Solna will be included in the trial. The patients should be able to talk and understand Swedish, live in the Stockholm County Council area and be mobile with or without walking aid.
Exclusion Criteria:
* Patients who will undergo radical cystectomy on a non-curative basis will not be included. | 8,612 |
Study Objectives
This is an open label long term follow up study, open to those subjects who were previously enrolled in"RAD001 Therapy of Angiomyolipomata in Patients with Tuberous Sclerosis Complex and Sporadic Lymphangioleiomyomatosis", CCHMC IRB #2008-0812 and who meet the criteria for this long-term follow-up study.
The hypothesis is that the drug will inhibit the growth of the angiomyolipomas and possibly even cause regression.
Conditions: Tuberous Sclerosis, Angiolipoma
Intervention / Treatment:
DRUG: everolimus (RAD001)
| Inclusion Criteria:
* Subjects must have met all eligibility criteria for the initial RAD001 protocol (CCHMC IRB 2008-0812)
* Subjects with documented angiomyolipoma volume decrease from baseline measures at the end of 12 months on study drug of thirty percent or more during the initial RAD001 protocol OR subjects with less than thirty percent decrease in angiomyolipomas at the end of 12 months on study drug but with documented improvement, or stabilization, of baseline clinical status per physical, pulmonary function and/or laboratory examination at the end of 12 months on study drug that was not maintained during a period of 12 or more months off study drug.
* If female and of child-bearing potential, documentation of negative pregnancy test prior to start of study drug
* Creatinine <3 mg/dl, within 30 days prior to start of drug
Exclusion Criteria:
* Inability to complete the initial RAD001 protocol (CCHMC IRB # 2008-0812) due to toxicities requiring discontinuation of treatment.
* Demonstrated an increase in the size of the angiomyolipoma from baseline at the end of 12 months on study drug on the initial RAD001 study.
* Significant hematologic or hepatic abnormality (i.e. ALT and AST >2.5x ULN), serum albumin <3 g/dl, HCT <30%, platelets <75,000/cumm, adjusted absolute neutrophil count <1,000/cumm, total WBC <3,000/cumm).
* Continuous requirement for supplemental oxygen.
* Intercurrent infection at initiation of RAD001.
* Embolization of angiomyolipoma within one month; any other recent surgery (within 2 months of initiation of RAD001).
* Pregnant or lactating women or women who plan on becoming pregnant during the course of this study due to unknown effects of RAD001 on the fetus.
* Inadequate contraception (participants who are fertile must maintain adequate contraception throughout the trial and for three months after stopping the drug). Acceptable contraceptive measures include non estrogen-containing birth control contraceptive regimen (progestin based contraceptives), prior hysterectomy, tubal ligation, complete abstinence, barrier methods which include a cervical diaphragm and spermicidal jelly, IUD, or vasectomy in partner.
* Use of an investigational drug, including rapamycin, within the last 30 days. | 18,751 |
Study Objectives
The focus of the study is to evaluate impact on Adenomas Per Colonoscopy (APC) with a Computer Aided Detection (CAD) software assisting the gastroenterologist during a colonoscopy procedure.
Conditions: Colo-rectal Cancer, Polyp of Colon, Adenomatous Polyps
Intervention / Treatment:
DEVICE: EndoVigilant CAD Software
| Inclusion Criteria:
* Patient presenting for routine colonoscopy for screening and/or surveillance purposes
* Ability to provide written, informed consent and understand the responsibilities of study participation
Exclusion Criteria:
* Patients with diminished cognitive capacity
* Patients with inflammatory bowel disease, ulcerative colitis or Crohn's colitis
* Patients with incomplete colonoscopies (due to technical difficulties or poor bowel prep) | 12,347 |
Study Objectives
The main aim of the study is to assess the effectiveness of tailored nutritional intervention in delaying the progression of cachexia to refractory cachexia in adult female cancer patients.
The tested hypothesis stated that intake of nutrient rich bread mix (along with dietary and physical activity counselling) for six months, improved the anthropometric and biochemical indices in free-living patients suffering from cancer cachexia.
Conditions: Cachexia, Cancer
Intervention / Treatment:
DIETARY_SUPPLEMENT: Improved Atta, OTHER: Nutritional counseling, BEHAVIORAL: Physical activity counseling
| Inclusion Criteria:
* Female, age 18 years and above.
* Diagnosed with cancer.
* Weight loss >5% from pre-treatment weight or BMI<20kg/m2.
* Hemoglobin level <12 g/dl.
* Energy intake < 1500 kcal/d (to be assessed on consultation).
Exclusion Criteria:
* Incapable to provide written consent.
* Patient diagnosed with refractory cachexia.
* Life expectancy < 3 months.
* Unresponsive to anti-cancer therapy.
* Patient is a pregnant woman or a nursing mother.
* Suffering from secondary illnesses.
* Gastrointestinal tract defects which affect nutrient absorption | 11,270 |
Study Objectives
Treatment outcome with ABVD in elderly patients remains inferior to adults. Moreover, Bleomycin-induced lung toxicity in the elderly has been reported as high as 46%. For these reasons, questions arise whether ABVD could be still considered the standard treatment in HL patients aged \> than 60. Regimens containing other alkylators such as CHOP proved even superior to ABVD, with a 3-y PFS of 67%. Frontline treatment of advanced-stage HL with Brentuximab Vedotin (BV) in association with AVD (Doxorubicin, Vinblastine, Dacarbazine) proved very active in a pioneer study, reporting the preliminary results of a phase 1 multicentre trial, in which the percentage of patients achieving CR was as high as 92%. For all these reason the investigators decided to test the association of an alkylator with an innovative mechanism of action and a very safe toxicity profile in the elderly such as Bendamustine (Be) with BV in untreated elderly HL patients.
The combination of BV and Be, investigated in this study, might represent an innovative treatment alternative for HL patients older than 60 years of age, especially for those of them in whom ABVD chemotherapy, the current standard front-line treatment, is not suitable. However, even when ABVD is given as upfront treatment for elderly HL patients, it is associated with substantial dose reduction, treatment delay, toxicity, and treatment-related mortality, with treatment outcomes remaining much inferior to those obtained in younger patients. This drug association is expected to be safe, well-tolerated and to demonstrate higher efficiency compared with ABVD. In this setting, it is expected that this therapy could be offered to the large majority of elderly patients with a full treatment completion reached in up to 80% of these patients.
Thus, the aim of this study will be to assess safety and efficacy of the above association.
Conditions: Clinical Efficacy, Safety
Intervention / Treatment:
DRUG: Adcetris-Levact
| Inclusion Criteria:
* Patients with advanced classical Hodgkin Lymphoma according to the World Health Organization classification. All Hasenclever IPS prognostic groups accepted* Stages IIB to IV B* Age 60-80 years included* Patient not previously treated* ECOG ≤ 2* Patient with adequate organ function:
* Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
* Haemoglobin ≥ 9 g/dL
* Platelets (PTL) ≥ 100 x 109/L
* AST - ALAT ≤ 2.5x ULN
* Bilirubin ≤ 1.5 x ULN
* Creatinine < 150 µmol/l (or 1.7 mg/dl)* Male patients, even if surgically sterilized, (i.e., status post vasectomy) and women of childbearing potential agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
* Contraception as described above is not a requirement if the female patient's postmenopausal status is documented (has had no menstrual period for at least 12 consecutive months)* Information delivered to patient and voluntary written informed consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.* Patient affiliated with a health insurance system.
Exclusion Criteria:
* Patients aged less than 60 years.* Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.* Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of PML.* Symptomatic neurologic disease compromising instrumental activities of daily living or requiring medication.* Symptomatic sensory or motor peripheral neuropathy.* Concurrent use of other investigational agents. In case of previous participation to a Clinical trial, a period of 30 days will be observed after the end of the previous Clinical Trial and before the inclusion in HALO study* Chemotherapy, biologics, and/or other treatment with immunotherapy not completed at least 4 weeks prior to first dose of study drug.* Patient who had major surgery less than 30 days before start of treatment* Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose.* Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of BV.* Patient presenting an uncontrolled infectious disease, including active HBV infection defined by either detection of HBs Antigen or presence of anti HBc antibody without detectable anti HBs antibody or HIV or HCV serology positivity. In case of HBc positive serology, a PCR could be performed in order to determine viral load. Patients with viral load defined as negative could be included.
o A prophylactic treatment will be strongly recommended (see HALO Study protocol, paragraph 6.2.3, page 36)* Patient with history of poor compliance or current or past psychiatric conditions or severe acute or chronic medical conditions, or laboratory abnormalities that would interfere, in the judgment of the investigator and/or sponsor, with the ability to comply with the study protocol.* Patients with uncompensated diabetes mellitus and fasting glucose levels over 180 mg/dl.* Known history of any of the following cardiovascular conditions
* Myocardial infarction within 2 years of enrollment
* New York Heart Association (NYHA) Class III or IV heart failure (see Appendix 12)
* Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities* Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50%* People particularly vulnerable including:
* Person deprived of liberty
* Adult patient entitled to protection of law | 4,330 |
Study Objectives
Many breast cancer patients will taking Chinese herbal medicine during receiving radiotherapy. The investigators conducted the pilot study showing Compound Herbal Formula (TPE-1) have the effect of improving the fatigue and leukopenia during radiotherapy. So the investigators designed this double blind and controlled trial to evaluate whether TPE-1 have the effects for leukopenia and cancer-related fatigue in breast cancer patients with radiotherapy. From our initial observation for 2 years, TPE-1 is safety. The study is also designed to evaluate the safety when patients taking this formula.
Conditions: Breast Cancer, Radiotherapy, Chinese Herbal Medicine
Intervention / Treatment:
DRUG: Chinese herbal medicine decoction
| Inclusion Criteria:
* breast cancer
* age between 18 to 70 yrs
* finished chemotherapy (adriamycin ), will receiving radiotherapy
* Chinese population
* KP$ between 40-100
* ECOG < 2
* WBC >4X10(9)/L and Hb > 10g/dl
* Assigned informed concent.
Exclusion Criteria:
* receiving operation during 14 days
* blood transfusion during one month.
* ALT >100mg/dL
* Creatinine >2.0mg/dL
* Total bilirubin >2.0mg/dL
* Infection
* prolation
* Taking anti-seizure , psychological drugs or any drugs not suitable patients
* AIDS or any disease diagnosed by physician and not suitable patients. | 9,154 |
Study Objectives
AVETUX is a single arm multicentric phase II investigator initiated trial conducted by the Arbeitsgemeinschaft Internistische Onkologie (AIO) in 11 German sites in patients with previously untreated RAS/BRAF wildtype mCRC independent of MSI status.
Conditions: Metastatic Colorectal Cancer
Intervention / Treatment:
DRUG: Avelumab
| Inclusion Criteria:
* Patients with histologically confirmed, previously untreated RAS and BRAF wildtype, MSI or MSS metastatic colorectal cancer (primary tumor may be present)* Patients with at least one measurable lesion acc. to RECIST v1.1* ECOG Performance status ≤ 1* Life expectancy > 3 months* Age ≥ 18 years.* Haematologic function as follows: ANC ≥ 1.5 x 10\^9/L, platelets ≥ 100 x10\^9/L, hemoglobin ≥ 9 g/dL or 5.59 mmol/L* Adequate liver function as measured by serum transaminases (AST \& ALT) ≤ 2.5 x ULN (in case of liver metastases < 5 x ULN) and total bilirubin ≤ 1.5 x ULN. Patients with known Gilbert disease who have serum bilirubin level ≤ 3 × ULN may be enrolled.* Adequate renal function: serum creatinine ≤ 1.5 x ULN* Negative serum pregnancy test at screening for women of childbearing potential. 10. 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 90 days after avelumab treatment and 6 month after standard chemotherapy.
* At least 6 months after completion of adjuvant chemotherapy. 12. Written informed consent 13. Ability to comply with the protocol for the duration of the study, including hospital/office visits for treatment and scheduled follow-up visits and examinations
Exclusion Criteria:
* Malignancies other than disease under study within 5 years prior to inclusion, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS > 90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)* All subjects with known brain metastases, except those meeting the following criteria:
1. Brain metastases that have been treated locally and are clinically stable for at least 2 weeks prior to enrolment
2. No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)
3. Subjects must be either off steroids or on a stable or decreasing dose of <10mg daily prednisone (or equivalent)* Prior organ transplantation, including allogeneic stem-cell transplantation* Significant acute or chronic infections including, among others:
1. Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
2. 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 not requiring immunosuppressive treatment are eligible)* Concomitant treatment with corticosteroids or other immunosuppressants, besides treatment of brain metastases as mentioned in criteria 2 or:
1. 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
2. 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 10. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrolment), myocardial infarction (< 6 months prior to enrolment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
* 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.
* All other significant diseases (for example, inflammatory bowel disease, uncontrolled asthma, colitis and pneumonitis), which, in the opinion of the Investigator, might impair the subject's tolerance of trial treatment 13. Any psychiatric condition that would prohibit the understanding or rendering of informed consent 14. Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines 15. Any approved anticancer therapy, including chemotherapy, hormonal therapy or radiotherapy, within 4 weeks prior to initiation of study treatment 16. Major surgical procedure within 28 days prior to treatment or anticipation of need for a major surgical procedure during the course of the study | 37,695 |
Study Objectives
This is a study to evaluate the effectiveness of using an established intervention for depressive symptom management in conjunction with a needs-based caregiver intervention for improving the psychological and physical health of family caregivers of persons recently diagnosed with a Primary Malignant Brain Tumor.
Conditions: Primary Malignant Brain Tumors
Intervention / Treatment:
BEHAVIORAL: CAU+ (Enhanced Care as Usual), BEHAVIORAL: Beating the Blues, BEHAVIORAL: SmartCare
| Inclusion Criteria:
Care recipient:
* Over 21 years of age.
* Newly (within 1 month) diagnosed with a PMBT (tumor verified via pathology report to be a glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, medulloblastoma, or anaplastic ependymoma).
Caregiver:
* Primary nonprofessional, non-paid caregiver, as identified by the care recipient.
* Over 21 years of age with telephone access.
* Reads-speaks English
* Obtains a score of >6 on the shortened CES-D.
* Caregivers may or may not be receiving pharmacotherapy for depressive symptoms
Exclusion Criteria:
Caregiver:
* Currently considers self to be a primary caregiver for anyone else other than children
* Currently receiving any type of formal counselling for depressive symptoms | 36,908 |
Study Objectives
This study will compare the efficacy of simtuzumab (GS-6624) versus placebo in combination with gemcitabine in adults with pancreatic cancer. The treatment phase of this study will be comprised of 2 sequential parts: an open label treatment phase and a double-blinded treatment phase.
Conditions: Pancreatic Cancer
Intervention / Treatment:
DRUG: Simtuzumab, DRUG: Gemcitabine, DRUG: Placebo to match simtuzumab
| Inclusion Criteria:
* Initial diagnosis of metastatic pancreatic cancer must have occurred ≤6 weeks prior to the completion of screening.
* The presence of measurable metastatic pancreatic cancer documented by contrast enhanced CT (or MRI) scan in addition to 1 of the following:
1. Histological diagnosis of pancreatic adenocarcinoma confirmed by pathologist OR
2. Pathologist confirmed histological/cytological diagnosis of adenocarcinoma consistent with pancreatic origin in conjunction with either:
1. The presence of a mass in the pancreas OR
2. A history of resected pancreatic carcinoma
* Measurable disease per RECIST (ver. 1.1)
* ECOG Performance Status of 0 or 1.
* Adequate hepatic, hematologic and renal functions.
Exclusion Criteria:
* A history or evidence of clinically significant disorder other than metastatic cancer of the pancreas.
* A diagnosis of pancreatic islet neoplasms.
* Subject has undergone major surgery other than diagnosis surgery within 4 weeks of randomization
* Presence of biliary obstruction requiring external drainage
* Brain metastases.
* Unstable cardiovascular function within the last 6 months of screening
* Clinically active liver disease, including active viral hepatitis (HBV or HCV) or cirrhosis
* Known HIV infection.
* Uncontrolled hypertension at Screening
* History or presence of any form of cancer, other than pancreatic cancer, within the 3 years prior to enrollment
* Prior or concurrent anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) for the treatment of inoperable locally advanced or metastatic pancreatic cancer; prior radiotherapy and chemotherapy given as pre-operative neoadjuvant therapy or radio sensitizers for locally advanced pancreatic cancer are allowed.
* Uncontrolled systemic fungal, bacterial or viral infection
* Participation in an investigational drug or device trial with therapeutic intent within 30 days prior to study | 33,655 |
Study Objectives
Based on these pre-clinical data, which were generated by our group, the investigators propose to test in a phase I/II clinical trial the following hypothesis: demethylation induced by decitabine results in re-sensitization to platinum in recurrent ovarian cancer.
To test this hypothesis, the investigators will treat patients with recurrent ovarian cancer platinum resistant (recurrence within 6 months from platinum therapy) or platinum-refractory (no response to platinum) with a combination consisting of decitabine and carboplatin.
This will be an institutional open label phase I/II trial to determine the safety and the biologic activity of the Decitabine/Carboplatin combination.
The investigators will determine whether Carboplatin can be safely combined with Decitabine, the optimal dose schedule and the investigators will define whether at this dosage, the regimen is biologically active (i.e. induces demethylation of target genes).
In the second part of the trial, the investigators will determine the clinical activity of the combination in a population of patients with platinum-resistant ovarian cancer.
Conditions: Ovarian Cancer
Intervention / Treatment:
DRUG: decitabine
| Inclusion Criteria:
* Have recurrent epithelial ovarian cancer, primary peritoneal carcinomatosis or fallopian tube cancer. - Have platinum-resistant (recurrence within 6 months of a platinum-containing regimen) or platinum refractory (progression while on platinum) disease - Have measurable disease according to RECIST or detectable disease. o Measurable disease is defined as the presence of at least one uni-dimensionally measurable lesion greater than or equal to 20 mm by conventional techniques, including palpation, plain x-ray, CT scan or MRI, or greater than or equal to 10 mm by spiral CT scan. o Detectable disease is defined in a patient as one who does not have measurable disease but has at least one of the following conditions: 1) Baseline values of cancer antigen 125 (CA-125) at least twice the upper limit of normal; 2) Ascites and/or pleural effusion attributed to tumor; 3) solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST definitions for target lesions. - >= 18 years of age. - Give written, informed consent for participation in the protocol. - Be at least 4 weeks from last treatment to allow recovery from prior toxicity (with the exception of hormonal therapy, where a 1-week wash-out period and radiation therapy where a 3-week wash-out period are sufficient). Patients coming off experimental therapy with biological agents not expected to cause myelotoxicity should have been off treatment for at least 3 weeks as wash-out period. - Have had disease that has progressed within 6 months platinum-based chemotherapeutic regimen. - Have no history of platinum allergy. - Have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception if hysterectomy and/or oophorectomy were not part of the prior treatment. It is expected that the overwhelming majority of ovarian cancer patients would have had hysterectomy and oophorectomy as part of the original surgery. - Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Have acceptable organ function, as evidenced by laboratory data: o Aspartate aminotransferase and alanine aminotransferase less than 2.5 times upper limit of normal (ULN) o Direct bilirubin less than 1.5 times ULN o Alkaline phosphatase less than 2.5 times ULN o Absolute neutrophil count greater than or equal to 1500 cells/mm3 o White cell blood count greater than 3000cells/mm3 o Hemoglobin greater than or equal to 9.0 g/dL (can be post-transfusion) o Platelets greater than 100,000/mm3 (can not be post-transfusion) o Creatinine levels less than 1.5 times ULN
Exclusion Criteria:
* Not have participated in any clinical trial involving conventional or investigational drugs or devices within the previous 3 weeks. - Not have grade 2 or greater neuropathy. - Have no additional active cancer in addition to the epithelial ovarian cancer within the last 5 years, with the exception of superficial skin cancer (basal cell or squamous cell skin carcinoma), carcinoma in situ of the cervix, Stage I endometrial cancer with less than 50% invasion of the myometrium, or other adequately treated Stage I or II cancer in complete remission. - Be free of active infection requiring antibiotic treatment. - Not have an additional uncontrolled serious medical condition or psychiatric illness. - Not have an immune deficiency and be receiving combination anti-retroviral therapy - Not have known brain metastases, as progressive neurologic dysfunction may develop, that would confound the evaluation of neurologic and other adverse events. - Absence of uncontrolled hypertension, arrhythmia, congestive heart failure or angina. Patients who have had a myocardial infarction or cardiac surgery should be at lease 6 months from the event and free of active symptoms. | 18,709 |
Study Objectives
The primary objective of this study is to determine the Maximum Tolerated Dose (MTD) for belinostat when combined with CHOP regimen and establish the recommended belinostat dose for the Phase 3 study.
Conditions: Peripheral T-cell Lymphoma
Intervention / Treatment:
DRUG: Belinostat, DRUG: CHOP
| Inclusion Criteria:
* Age 18 years or above
* Life Expectancy > 3 months
* Histologically confirmed diagnosis of PTCL
* Patients with transformed CTCL eligible for CHOP regimen
* Measurable disease based on Cheson 2007 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status < 2
Exclusion Criteria:
* Known active Hepatitis B/ Hepatitis C/ HIV infection
* Known, uncontrolled CNS metastases or primary CNS lymphoma
* Deep vein thrombosis diagnosed within 3 months
* Ongoing treatment for pre-existing cardiovascular disease
* Neuropathy Grade 3 or more
* Previous extensive radiotherapy except limited field RT for locally advanced nasal NK PTCL or for pain palliation
* Prior therapy with severely myelotoxic regimens, including autologous and allogenic stem cell transplantation
* Prior therapy with HDAC inhibitors (except for CTCL)
* Inadequate hematological, hepatic, or renal function | 31,849 |
Study Objectives
Colonoscopy is one of the most common methods for the diagnosis and treatment of lower gastrointestinal tract diseases and provides a unique opportunity to identify early neoplastic lesions.
Adequate bowel preparation is important for optimal colonoscopy. New bowel-cleansing regimens, study of patient-related risk factors to fail a proper preparation and diet adaptations have been studied recently.
A low residue diet is the standard in the day before the colonoscopy. Some endoscopists prescribe this dietary plan for a 3-day period prior to the exam, although no study compared the recommended 1-day versus 3-day diet regime, or the influence in bowel preparation results.
The aim of this project is to determine if the use of a 3-day low residue diet improves bowel preparations results and the influence in patient tolerability and adherence.
Conditions: Colon Disease, Colonic Neoplasms
Intervention / Treatment:
OTHER: 3 day low residue diet prior to the colonoscopy, OTHER: 1 day low residue diet prior to the colonoscopy
| Inclusion Criteria:
* Consecutive series of patients scheduled for total colonoscopy
* Signed informed consent
Exclusion Criteria:
* inpatients
* sedation
* urgent procedures
* colonoscopies not intended to reach the caecum
* patient with previous partial colectomy. | 2,868 |
Study Objectives
Recent studies have shown that survival after a colorectal cancer diagnosis may be affected by a person's activity level and body size. This research says that for colorectal cancer patients, the less active and more obese they are, the more likely they are to have a cancer recurrence or die from their cancer. Chemotherapy has been shown to reduce activity levels, fitness, and body size in some cancer patients. However, it is not known how chemotherapy specific for colon cancer patients affects their activity levels, fitness, and body size. The main goal of our study will be to look at how chemotherapy treatments affect the fitness, activity levels, and body size in colon cancer patients. In order to do this, we will measure these variables before chemotherapy treatments, and at 1 and 6 months following the end of treatment. Our results will show how chemotherapy affects fitness, activity levels, and body size in colon cancer patients and provide data to help in designing an exercise intervention specifically for colon cancer survivors.
Conditions: Colonic Neoplasms
Intervention / Treatment:
| Inclusion Criteria:
* histologically confirmed colon cancer (Stage III and those Stage II patients deemed high-risk
* approval of the treating oncologist
* scheduled to received chemotherapy
* able to understand and provide written informed consent in English
* 18+ years of age
* no uncontrolled co-morbidities (including hypertension, cardiac illness, psychiatric condition, etc.)
* negative ECG as assessed during maximal graded exercise test
Exclusion Criteria:
* metastatic or recurrent colon cancer patients
* pregnancy
* any uncontrolled medical condition that would be a contraindication to exercise (assessed by treating oncologist)
* unwilling to attend, travel to or participate in the assessments at all 3 time points
In addition, 10 patients meeting all of the eligibility criteria who are not scheduled to receive chemotherapy will also be recruited to the study to serve as "surgery only" controls. | 17,930 |
Study Objectives
This is a phase II study of the combination of radiation therapy, temozolomide and Avastin followed by Avastin, temozolomide, and topotecan in grade IV malignant glioma patients.
Conditions: Malignant Glioma, Glioblastoma, Gliosarcoma
Intervention / Treatment:
DRUG: Bevacizumab, DRUG: Temozolomide, RADIATION: Radiation Therapy (XRT), DRUG: Topotecan
| Inclusion Criteria:
* Patients must have histologically confirmed diagnosis of WHO grade IV primary malignant glioma (glioblastoma multiforme or gliosarcoma). Patients have to be within 6 weeks of the last major surgical procedure.
* Age > or = to 18 years.
* An interval of at least 2 weeks and not > 6 weeks between prior major surgical procedure and study enrollment.
* No prior radiotherapy or chemotherapy for a brain tumor
* Karnofsky > or = to 60%.
* Hemoglobin ≥ 9.0 g/dl, absolute neutrophil count (ANC) ≥ 1,500 cells/microliter, platelets ≥ 125,000 cells/microliter.
* Serum creatinine ≤ 1.5 mg/dl, serum glutamic oxaloacetic transaminase (SGOT) and bilirubin ≤ 1.5 times upper limit of normal.
* Signed informed consent approved by the Institutional Review Board
* If sexually active, patients must agree to use appropriate contraceptive measures for the duration of the study and for 6 months afterwards as stated in the informed consent.
Exclusion Criteria:
* Pregnancy or breast feeding.
* Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids.
* Active infection requiring IV antibiotics.
* Prior treatment with radiotherapy or chemotherapy for a brain tumor, irrespective of the grade of the tumor.
* Evidence of > grade 1 central nervous system (CNS) hemorrhage on baseline MRI on CT scan.
Avastin-specific Exclusion Criteria:
* Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg)
* Prior history of hypertensive crisis or hypertensive encephalopathy
* New York Heart Association (NYHA) Grade II or greater congestive heart failure
* History of myocardial infarction or unstable angina within 6 months prior to study enrollment
* History of stroke or transient ischemic attack within 6 months prior to study enrollment
* Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to study enrollment
* History of hemoptysis (≥ ½ teaspoon of bright red blood per episode) within 1 month prior to study enrollment
* Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
* Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
* History of abdominal fistula, gastrointestinal perforation within 6 months prior to study enrollment
* Serious, non-healing wound, active ulcer, or untreated bone fracture
* Proteinuria at screening as demonstrated by either urine protein:creatinine (UPC) ratio ≥ 1.0 at screening OR urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).
* Known hypersensitivity to any component of Avastin
* Pregnant (positive pregnancy test) or lactation. Use of effective means of contraception (men and women) in subjects of child-bearing potential | 17,399 |