data
stringlengths 112
4.42k
| criteria
stringlengths 19
13.2k
|
|---|---|
Study Objectives
This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical trial to evaluate the efficacy and safety of Fruquintinib plus best supportive care in patients with advanced non-squamous non-small cell lung cancer who failed to second-line standard chemotherapy.
Intervention / Treatment
DRUG: Fruquintinib, DRUG: Placebo
| Inclusion Criteria:
* Fully understand the study and sign the informed consent form voluntarily;
* Histologically and/or cytologically diagnosed with local advanced and/or metastatic stage IIIB/IV non-squamous NSCLC;
* Previously failed to two chemotherapy regimens(treatment failure is defined as disease progression or intolerable toxicity), patients with positive EGFR mutation permitted to treated by EGFR-TKI previously; patients with EGFR wild type or unknown whether or not treated by EGFR-TKI previously;
* Aged 18-75 years (inclusive);
* Body weight ≥40 kg;
* Evident measurable lesion(s) (according to RECIST*1);
* ECOG Performance Status 0-1;
* Expected survival >12 weeks
Exclusion Criteria:
* Treatment in another clinical trials in the past 3 weeks; or treatment with systemic anti-tumor chemotherapy, radiotherapy or biotherapy within 3 weeks prior to administration of the study drug;
* Previous therapy with VEGF/VEGFR inhibitors;
* Unrecovered from toxicity caused by previous anti-cancer treatment (CTCAE >grade 1), or not completely recovered from previous surgery;
* Previous active brain metastasis (without radiotherapy previously, or symptoms stable < 4 weeks, or with clinical symptoms, or with medication to control symptoms);
* Other malignancies except basal cell carcinoma or cervical carcinoma in situ in the past 5 years;
* Uncontrolled clinical active infection, e.g. acute pneumonia and active hepatitis B;
* Dysphagia or known drug malabsorption;
* Present active duodenal ulcer, ulcerative colitis, intestinal obstruction and other gastrointestinal diseases or other conditions that may lead to gastrointestinal bleeding or perforation according to the investigators' judgment; or with a history of intestinal perforation or intestinal fistula;
* Have evidence or a history of thrombosis or bleeding tendency, regardless of seriousness;
* Stroke and/or transient ischemic attack within 12 months prior to enrollment;
* Appropriate organ function. Patients with any of the following conditions will be excluded:
* Absolute neutrophil count (ANC) <*5×109/L, platelet <100×109/L or hemoglobin <9 g/dL within 1 week prior to enrollment;
* Serum total bilirubin >*5 upper limit of normal (ULN), alanine transaminase and aspartate transferase >*5×ULN; ALT and AST > 3×ULN in patients with liver metastasis;
* Electrolyte abnormality of clinical significance;
* Blood creatinine >ULN and creatinine clearance <60 ml/min;
* Urine protein 2+ or above, or 24 h urine protein quantification ≥*0 g/24 h;
* Activated partial thromboplastin time (APTT) or/and INR and prothrombin time (PT) >*5×ULN (according to reference range in each clinical study center);
* Uncontrolled hypertension, systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg with medication; or heart failure NYHA classification ≥ grade 2;
* Heart function evaluation: left ventricular ejection fraction <50% (echocardiography);
* Acute myocardial infarction, severe/unstable angina or coronary bypass surgery within 6 months prior to enrollment; history of arterial thrombosis or deep venous thrombosis;
* Skin wound, surgical site, wound site, severe mucosal ulcer or fracture without complete healing;
* Female subjects who are pregnant or lactating or of child bearing potential with positive pregnancy test result before the first dose;
* Patients with child bearing potential who or whose sexual partners are not willing to take contraceptive measures;
* Any clinical or laboratory abnormalities unfit to participate in this clinical trial according to the investigator's judgment;
* Serious psychological or psychiatric disorders which may affect subject compliance in this clinical study;
* Allergy to Fruquintinib and/or excipient contained in trial drugs. |
Study Objectives
The purpose of this study is to find a safe dose of actinium-225 when it is labeled to HuM195. This will be done with a "phase I trial," in which a preset schedule of doses gets more powerful for each new group of patients as the trial progresses. If too many serious side effects are seen with a certain dose, no one will be treated with a higher dose, and some additional patients may be treated with a lower dose to make sure that this dose is safe. The starting dose of actinium-225 in this study is less than doses that are known to be safe in animals.
Antibodies are proteins that are produced by the immune system and help the body to fight foreign substances, such as bacteria or viruses. HuM195 was made by putting human leukemia cells into mice. Most of the mouse parts of this antibody were replaced with human parts. Only the part of the antibody that binds to the leukemia cells was kept from the mouse. HuM195 attaches to leukemia cells but does not attach to most normal cells. It can kill small amounts of disease by identifying the leukemia cells as "foreign." HuM195 has worked less well against large amounts of leukemia since the normal immune cells needed to kill leukemia cells are lowered in most patients with leukemia.
Intervention / Treatment
BIOLOGICAL: ACTINIUM-225-LABELED HUMANIZED ANTI-CD33 MONOCLONAL ANTIBODY HuM195
| Inclusion Criteria:
* Patients must have one of the following pathologically confirmed diagnoses:
* AML in relapse,
* AML refractory to at least 2 courses of standard induction chemotherapy or one course of high-dose cytarabine-containing induction chemotherapy,
* CML in accelerated phase or myeloid blast crisis that has progressed after treatment with imatinib and a second generation tyrosine kinase inhibitor (e.g., dasatinib or nilotinib)
* RAEB with International Prognostic Scoring System (IPSS) score ≥ *5, or - CMMOL with IPSS score ≥ *5 refractory to or relapsed after a hypomethylating agent (e.g., azacitidine or decitabine) refractory to or relapsed after a hypomethylating agent (e.g., azacitidine or decitabine).
* Greater than 25% of bone marrow blasts must be CD33 positive.
* Patients must have a life expectancy of at least 6 weeks and a Karnofsky performance status of ≥ 60%.
* Adequate renal function as demonstrated by a serum creatinine ≤ *5 mg/dl, a creatinine clearance > 60 ml/min, and < 1 gram urinary protein/24 hours.
* Adequate hepatic function as demonstrated by a bilirubin ≤ *5 mg/dl (unless attributable to leukemia or Gilbert's disease) and alkaline phosphatase and AST ≤ *5 times the upper limit of normal.
Exclusion Criteria:
* Untreated AML, regardless of prognostic features.
* Treatment with chemotherapy or biologic therapy within 3 weeks of 225Ac- HuM195 administration. Hydroxyurea is permitted but must be discontinued prior to treatment on study. Patients must have recovered from the effects of previous treatment.
* Treatment with radiation therapy within 6 weeks of 225Ac-HuM195 administration. Patients must have recovered from the effects of previous treatment.
* Active serious infections not controlled by antibiotics.
* Pregnant women or women who are breast-feeding.
* Concurrent active malignancy requiring therapy.
* Clinically significant cardiac disease (NY Heart Association Class III or IV)or pulmonary disease.
* Patients with HLA-compatible donor bone marrow who are immediate candidates for bone marrow transplantation.
* Patients who are candidates for alternative treatments of known effectiveness.
* Patients eligible for protocols of higher priority.
* Patients previously treated with any monoclonal antibody for any reason.
* Active CNS leukemia
* Other serious or life-threatening conditions deemed unacceptable by the principal investigator. |
Study Objectives
RATIONALE: Gathering health information about patients with liver cancer over time may help doctors learn more about the disease and may help the study of cancer in the future.
PURPOSE: This clinical trial is developing a national registry and blood bank of patients with liver cancer.
Intervention / Treatment
OTHER: biologic sample preservation procedure, OTHER: medical chart review, OTHER: Patient interview
| Inclusion Criteria:
* Diagnosis of hepatocellular carcinoma at a participating institution
Exclusion Criteria:
* None |
Study Objectives
The purpose of this study is to study the safety and clinical activity of nivolumab and ipilimumab in combination with either sequential administration of CY/GVAX pancreas vaccine followed by CRS-207 (Arm A) or with administration of CRS-207 alone (Arm B) in patients with pancreatic cancer.
Intervention / Treatment
DRUG: Cyclophosphamide, DRUG: Nivolumab, DRUG: Ipilimumab, DRUG: GVAX Pancreas Vaccine, DRUG: CRS-207, DRUG: CRS-207
| Inclusion Criteria:
* Age ≥18 years.
* Have histologically or cytologically proven adenocarcinoma of the pancreas.
* Have metastatic disease.
* Have disease progression.
* Patients with the presence of at least one measurable lesion.
* Patient's acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator).
* ECOG performance status 0 or 1
* Life expectancy of greater than 3 months.
* Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
* Must use acceptable form of birth control while on study.
* Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
* Known history or evidence of brain metastases.
* Had surgery within the last 28 days
* Had chemotherapy, radiation, or biological cancer therapy within the last 14 days
* Have received a prophylactic vaccine within 14 days or received a live vaccine within 30 days of planned start of study therapy.
* Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2,or anti-CTLA4
* Systemic steroids within the last 14 days
* Use more than 2 g/day of acetaminophen.
* Patients on immunosuppressive agents.
* Patients receiving growth factors within the last 14 days
* Known allergy to both penicillin and sulfa.
* Severe hypersensitivity reaction to any monoclonal antibody.
* Have artificial joints or implants that cannot be easily removed
* Have any evidence of clinical or radiographic ascites.
* Have significant and/or malignant pleural effusion
* Have had a new pulmonary embolism, extremity deep venous thromboembolism, or portal vein thrombosis within 2 months of study treatment
* Infection with HIV or hepatitis B or C at screening
* Significant heart disease
* Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures
* Are pregnant or breastfeeding.
* Have rapidly progressing disease |
Study Objectives
The aim of this study is to establish a clinical score panel based on clinical, molecular and genetic parameters that allow us to stratify and obtain an early detection of patients with an increased risk of developing hepatocellular carcinoma (HCC).
Intervention / Treatment
| Inclusion Criteria:
* Human immunodeficiency virus chronic infection
* Hepatitis C virus chronic infection
* No other liver viral coinfections
Exclusion Criteria:
* Alcohol consume
* Immunosuppressor or immunoactive treatment |
Study Objectives
The goal of this study is to determine the feasibility and efficiency of incorporating 19F MR functional lung imaging into the routine assessment of lung cancer patients prior to thoracic radiotherapy.
Intervention / Treatment
DRUG: Perfluorinated Gas/Oxygen Mixture
| Inclusion Criteria:
* Subject has histologic or cytologic confirmation of lung cancer (NSCLC or Small cell) and has been recommended thoracic radiotherapy as part of standard of care management.
* Ability to undergo MR imaging, tolerate breath hold procedures and follow direction during the imaging process
* Karnofsky performance status ≥60, with expected survival of ≥6 months
* At least 18 years of age
* Patient is not pregnant
* Patient can be reliably reached for post-MRI follow up AE check.
* Patient able to sign a study specific informed consent form.
Exclusion Criteria:
* Any condition including, metallic implants or cardiac pacemakers that makes the candidate ineligible for MR imaging. (MRI research screening form will be completed prior to each MRI scan).
* Malignant pleural effusion or pericardial effusion |
Study Objectives
Primary Objectives:
1. To determine the efficacy of administering multiple doses of intravenous (i.v.) busulfan at a dose of 130 mg/m2, to yield a systemic plasma drug exposure represented by a daily area under the plasma concentration versus time curve (AUC) of approximately 5,000 mMol-min for 4 days, followed by i.v. melphalan at a dose of 70 mg/m2 for 2 days in adult patients receiving autologous or allogeneic transplantation for lymphoid malignancies or myeloma.
2. To describe the plasma pharmacokinetic (PK) profiles of busulfan and melphalan in this regimen.
3. To determine the disease-free and overall survival of patients receiving this preparative regimen.
4. To determine the treatment-related morbidity and mortality of this combination of drugs.
Intervention / Treatment
DRUG: Busulfan, DRUG: Melphalan
| Inclusion Criteria:
* Patients with lymphoid malignancies, including Hodgkin's and non-Hodgkin's lymphoma (primary refractory or recurrent), or multiple myeloma (beyond first complete remission or unresponsive to therapy. Complete remission for multiple myeloma defined by absence of detectable paraprotein in serum and/or urine by immunoelectrophoresis or immunofixation, and < 5% plasma cells in the bone marrow), not qualifying for treatment protocols of higher priority.
* Age 18 to 65 years of age.
* Adequate renal function as defined by estimated serum creatinine clearance > 50 ml/min and serum creatinine < *8 mg/dL.
* Adequate hepatic function, as defined by serum glutamic pyruvic transaminase (SGPT) < 3 \* upper limit of normal; serum bilirubin and alkaline phosphatase < 2 \* upper limit of normal, or considered not clinically significant.
* Adequate pulmonary function with Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and Capacity of the Lung for Carbon Monoxide (DLCO)> 50%. Exceptions may be allowed for patients with pulmonary involvement after discussing with principal investigator (PI).
* Adequate cardiac function with left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
* Zubrod performance score < *
* Patients receiving an allogeneic transplant must have an HLA matched, or one A, B, or DR mismatched related donor. Unrelated donor must be matched at A, B, and DR (defined as A, B serologic matched and DRB1 molecular matched). Donor must be willing to donate peripheral blood or bone marrow progenitor cells.
* Patient and donor should be willing to participate in the study by providing written consent.
* Female patient must not be pregnant and have negative pregnancy.
Exclusion Criteria:
* Patients with unresolved grade >/= 3 non-hematologic toxicity from previous therapy. Patients with grade 2 toxicity will be eligible at the discretion of the PI.
* Patients with active Central Nervous System (CNS) disease.
* Evidence of acute or chronic active hepatitis or cirrhosis. If positive hepatitis serology, discuss with Study Chairman and consider liver biopsy.
* Uncontrolled infection, including Human immunodeficiency virus (HIV) or Human T-lymphotropic virus Type I (HTLV-1) infection.
* Patients who have had a previous autologous or allogeneic stem cell transplant during the past year. |
Study Objectives
The purpose of this study is to determine maximum tumor shrinkage, time to progression, survival, drug concentration, and degree of skin toxicity.
Intervention / Treatment
DRUG: placebo, DRUG: Sorafenib, DRUG: Sorafenib
| Inclusion Criteria:
* Histologically or cytologically confirmed metastatic clear cell renal cell cancer;
* At least one lesion that can be accurately measured in at least one dimension;
* Patients must not have been treated with prior anti-timor kinase inhibitors or VEGF pathway inhibitors;
* Age 18 and older;
* ECOG performance status 0-2;
* Blood pressure higher than 140/90 on 2 separate occasions not more than 6 weeks prior to enrollment and not less than 24 hours apart;
* Normal organ function: total bilirubin less than upper limit of normal, AST less than *5 X upper limit of normal, creatinine less than *8 mg/dl;
* Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation;
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Chemotherapy or radiotherapy within 4 weeks prior to entering the study;
* Any other investigational agents;
* Known brain metastases;
* Uncontrolled intercurrent illness including 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;
* Pregnancy. |
Study Objectives
Hepatocellular carcinoma is multifactorial in etiology and complex in pathogenesis, the blend of risk factors differs in different parts of the world, and this may explain in part the diverse biologic characteristics of HCC in different populations .
Exposure to aflatoxin is an additional risk factor for the development of HCC, through damage of DNA in liver cells and mutation in p53 tumor suppressor gene . A previous study showed that aflatoxin B1 has a considerable role in the development of HCC among Egyptians .
Clinical studies have shown that AFB1 selectively targets at the third base position of codon 249 of the human p53 gene, a known mutational hotspot in human hepatocellular carcinoma (HCC) . A significant association between aflatoxin exposure and HCC has been reported in hyperendemic areas . A synergistic interaction between AFB1 exposure and viral hepatitis B (HBV) infection on HCC risk has been reported in several epidemiologic studies.
Aflatoxin exposure may be associated with advanced liver disease in chronic hepatitis C (HCV) patients. Levels of AFB1-albumin/albumin were significantly related to ultrasono-graphic hepatic parenchyma scores in anti-HCV-positive subjects .
Intervention / Treatment
OTHER: Aflatoxin
| Inclusion Criteria:
* cirrhotic patient with and without HCC
Exclusion Criteria:
* Malignancy other than HCC |
Study Objectives
Although the harms of screening for prostate cancer with the prostate-specific antigen (PSA) test outweigh the benefits, 560,000 Ontario men undergo PSA screening each year. Guideline developers, such as the Canadian Task Force on Preventive Health Care (CTFPHC), have disseminated patient educational materials (PEMs) on PSA screening widely in Ontario, yet men remain confused about screening harms and benefits. One potential contributing factor may be that PEMs are typically developed by researchers and clinicians and may not address patient barriers to change. The investigators will assess whether a PSA screening PEM that is co-created with patients provides added value over PEMs developed using the traditional approach (i.e., researchers and clinicians develop a PEM with patient involvement in usability testing only. The investigators will also assess satisfaction with the engagement process and calculate the costs and resources required for each method (i.e. co-creation, usability, and recommendations only). This study will generate a PSA screening PEM to help patients make evidence-based screening decisions. It will also help Ontario organizations, including Cancer Care Ontario, identify optimal methods for developing PEMs for PSA screening and other areas of preventive health care, such as breast and colorectal cancer screening.
Intervention / Treatment
OTHER: Co-created PEM
| Inclusion Criteria:
* English-speaking men aged 40+ years will be eligible to take part in the project if they have never been diagnosed with prostate cancer and do not have any signs or symptoms of prostate cancer.
Exclusion Criteria:
* Individuals will not be eligible for the project if they indicate that they are a health care professional or have any conflicts of interest relevant to the guideline topic (e.g., owning shares in a company related to prostate cancer treatment). |
Study Objectives
The current strategy is to test for treatment resistance at the time of radiological progression and design subsequent treatment based on the mechanism of resistance. However, upon disease progression patients tend to deteriorate quickly and 30% - 40% of patients will not be in the clinical condition to receive next line treatment. Therefore, there is a potential for early resistance identification and directing treatment against it in order to improve patient outcome.
Intervention / Treatment
DIAGNOSTIC_TEST: ctDNA blood sample
| Inclusion Criteria:
* Histologically confirmed metastatic NSCLC, characterized by a sensitizing exon 19 deletion or exon 21 L858R EGFR mutation.
* WHO performance status 0-*
* Eligible for osimertinib treatment according to the label and according to the treating physician.
* Patients must be ≥18 years of age.
Exclusion Criteria:
* Patients with symptomatic central nervous system metastases who are neurologically unstable. Unstable brain metastases except for those who have completed definitive therapy and have had a stable neurological status for 2 weeks after completion of definitive therapy. Patients may be on corticosteroids to control brain metastases if they have been on a stable dose for 2 weeks prior to the start of study treatment and are clinically asymptomatic. |
Study Objectives
This trial is to determine what dose of a drug called AZD1775 can safely be given in combination with cisplatin before surgery and with chemo-radiotherapy after surgery in patients with Head and Neck Cancer. The Investigators will also get some preliminary information regarding the effectiveness of this combined treatment.
Intervention / Treatment
DRUG: AZD1775, DRUG: Cisplatin, RADIATION: Radiotherapy
| Inclusion Criteria:
* Histologically confirmed diagnosis of oral, laryngeal or hypopharyngeal squamous cell carcinoma
* Multi-Disciplinary Team (MDT) recommendation for surgical resection with curative intent
* Eastern Cooperative Oncology Group (ECOG) performance status 0/1
* Age ≥18 to ≤70 years
* Creatinine clearance, measured by Glomerular Filtration Rate (GFR), ≥ 60 ml/min at baseline calculated using local practice calculation. If this is ≤ 60 ml/min then an isotopic GFR may be carried out and must be > 60 ml/min
* Acceptable cardiac function. If significant cardiac history, then required for patient to have Left Ventricular Ejection Fraction (LVEF) ≥55% by echocardiogram (ECHO) or Multiple Gated Acquisition Scan (MUGA, if ECHO is equivocal)
* Normal liver and bone marrow function:
* Haemoglobin (Hb) ≥*0 g/dL or ≥100 g/L
* Absolute neutrophil count (ANC) ≥*5 x 109/L
* Absolute platelet count ≥100 x 109/L
* Aspartate transaminase (AST) or alanine aminotransferase (ALT) ≤*5 upper limit of normal (ULN)
* Total bilirubin ≤*5 ULN (except for patients with known Gilbert's syndrome)
* Male and female participants must agree to take appropriate measures to prevent pregnancy. Contraceptive measures should be used for 2 weeks prior to trial entry, during the trial and for at least 6 months after last receiving treatment. Acceptable methods of contraception include total abstinence (if this is the patient's usual and preferred lifestyle choice), tubal ligation, combined oral, transdermal or intra-vaginal hormonal contraceptives, medroxyprogesterone injections (e.g. Depo-Provera), copper-banded intra-uterine devices; hormone impregnated intra-uterine systems and vasectomised partners. All methods of contraception (with the exception of total abstinence) should be used in combination with the use of a condom by their male sexual partner for intercourse.
Inclusion criteria Group A - in addition to general criteria
* Accessible tumours for re-biopsy under local anaesthetic or via ultrasound guided biopsy
Inclusion criteria Group B - in addition to general criteria
* High-risk histopathological features after surgical resection, i.e. nodal extra-capsular spread and/or tissue resection margin <1 mm as agreed at MDT
* Patients who have previously registered to Group A can be considered for inclusion in Group B
Exclusion Criteria:
* Any previous treatment for the same cancer, or previous head and neck malignancy, apart from laser excision of carcinoma in situ, with minimal residual functional deficit or registration and treatment in Group A prior to surgery
* Patients with cancer of the oropharynx or non-primary cancer will not be included
* Any metastatic disease from any primary site
* Use of an Investigational Medicinal Product (IMP) concurrently or within 4 weeks of starting this trial
* Uncontrolled intercurrent illness, which will interfere with the patient's participation in the trial, e.g.:
* myocardial infarction within 6 months
* congestive cardiac failure
* unstable angina
* symptomatic cardiomyopathy
* chronic infections
* active peptic ulcer or liver disease
* serious psychiatric condition limiting ability to comply with trial protocol
* Clinical evidence of current heart failure (≥New York Heart Association (NYHA) Class II)
* Clinical evidence of atrial fibrillation (with heart rate >100 bpm, within 6 months prior to trial entry)
* Unstable ischaemic heart disease (Myocardial Infarction within 6 months prior to trial entry or angina requiring the use of nitrates greater than once weekly)
* Patients who have a history of Torsades de pointes (unless all risk factors that contributed to Torsades de pointes have been corrected)
* Active gastro-intestinal disease that might limit absorption of study drug, e.g. coeliac disease, Crohn's disease, ulcerative colitis, pancreatic insufficiency
* Evidence of any psychological, familial, sociological or geographical condition potentially hampering protocol compliance
* Participation in another interventional clinical trial whilst taking part in this trial
* Patients who are unable to discontinue any prohibited drug and unable to tolerate a washout period for at least 14 days prior to trial entry
* Clinical judgement by the Investigator that the patient should not participate in the study
* Known hypersensitivity to the study drugs or active substances or excipients of the preparations
* Pregnant or breast feeding patients
* Significant pre-existing neuropathy which currently interferes with the patient's daily life
* Mean resting corrected QTc interval using the Fridericia formula (QTcF) >450 msec (male) and >470 msec (female) (as calculated per institutional standards) obtained from 3 electrocardiograms (ECGs) 2-5 minutes apart at study entry, or congenital long QT syndrome
* Inability to swallow oral medications |
Study Objectives
This randomized, double-blind, controlled, outpatient two-period, two-treatment crossover study is designed to evaluate the efficacy and safety of amifampridine phosphate in patients (ages 2 and above) diagnosed with certain genetic subtypes of CMS and demonstrated open label (amifampridine phosphate) or history of sustained amifampridine benefit from treatment.
Intervention / Treatment
DRUG: amifampridine phosphate, DRUG: Placebo
| Inclusion Criteria:
Individuals eligible to participate in this study must meet all of the following inclusion criteria:
* Patient's or parent willing and able to provide written informed consent after the nature of the study has been explained and before the start of any research-related procedures, or the patient's legal guardian or caregiver with durable power of attorney can provide written informed consent. An assent form must also be signed if in the judgement of the IRB the children are capable of providing assent.
* Male or female age 2 and above.
* Body weight ≥10 kg.
* Genetically-confirmed CMS involving acetylcholine receptor defect, Rapsyn deficiency, MuSK deficiency, Dok-7 deficiency, SYT2 deficiency,SNAP25B deficiency, and fast channel syndrome.
* MFM 20 or 32 score equal or less than 48 or 76, respectively, at Screening.
* In patients naïve to 3,4-DAP or amifampridine phosphate, improvement of >20% in MFM20 or MFM32 scores after open label period of up titration of dose
* In patients previously stabilized on 3,4-DAP or amifampridine phosphate, history of meaningful improvement in motor function (in opinion of investigator)
* Willingness of patients receiving pyridostigmine, prednisone, albuterol, ephedrine, or fluoxetine to remain on a stable dose of these medications throughout the study interval.
* Female patients of childbearing potential must have a negative pregnancy test (serum human chorionic gonadotropin \[HCG\] at Screening); and must practice effective, reliable contraceptive regimen during the study.
* Ability to participate in the study based on overall health of the patient and disease prognosis, as applicable, in the opinion of the investigator; and able to comply with all requirements of the protocol.
Exclusion Criteria:
Individuals who meet any of the following exclusion criteria are not eligible to participate in the study:
* CMS subtype diagnosis of acetylcholinesterase deficiency, slow-channel syndrome, LRP4 deficiency, and plectin deficiency.
* Cardiac conduction defects on Screening ECG.
* Seizure disorder.
* Abnormal liver function tests at Screening.
* Abnormal kidney function tests at Screening.
* Abnormal electrolyte values at Screening.
* Pregnancy or breastfeeding at Screening or planning to become pregnant at any time during the study.
* Any systemic bacterial or other infection, which is clinically significant in the opinion of the investigator and has not been treated with appropriate antibiotics.
* Treatment with an investigational drug (other than amifampridine phosphate), device, or biological agent within 30 days before Screening or while participating in this study.
* Any other medical condition that, in the opinion of the investigator, might interfere with the patient's participation in the study, poses an added risk for the patient, or confound the assessment of the patient.
* History of drug allergy to any pyridine-containing substances or any amifampridine phosphate excipient(s). |
Study Objectives
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of eculizumab in the treatment of pediatric refractory gMG based on change from Baseline in the Quantitative Myasthenia Gravis (QMG) score for disease severity.
Intervention / Treatment
DRUG: Eculizumab
| Inclusion Criteria:
* Male or female pediatric participants 6 to <18 years of age at time of assent/consent.
* Vaccinated against Neisseria meningitidis.
* Documented vaccination against Haemophilus influenzae and Streptococcus pneumoniae infections prior to dosing as per local and country specific immunization guidelines for the appropriate age group.
* Diagnosis of MG confirmed by positive serologic test for anti-acetylcholine receptor antibodies at Screening, and 1 of the following: (a) history of abnormal neuromuscular transmission test demonstrated by single-fiber electromyography or repetitive nerve stimulation; (b) history of positive anticholinesterase test (for example, edrophonium chloride or neostigmine test); or (c) participant demonstrated improvement in MG signs on oral acetylcholinesterase inhibitors, as assessed by the Investigator.
* Presence of refractory gMG, defined as participants with gMG who have 1 or more of the following: (a) failed treatment ≥1 year with at least 1 immunosuppressive therapies (IST), defined as follows: * persistent weakness with impairment of activities of daily living; * myasthenia gravis (MG) exacerbation and/or crisis while on treatment; or * intolerance to ISTs due to side effect or comorbid condition(s). (b) Require maintenance plasma exchange (PE) or intravenous immunoglobulin (IVIg) to control symptoms; and/or (c) in the opinion of the Investigator, MG poses a significant functional burden despite current MG treatment.
* MGFA Clinical Classification of Class II to IV at Screening.
* In patients aged 12 to 18 years, QMG total score ≥ 12 at Screening; in patients aged 6 to 11 years, no minimum QMG is required for inclusion; however, patients must have documented limb weakness in at least one limb.
* All MG-specific treatment has been administered at a stable dosing regimen of adequate duration prior to Screening.
Exclusion Criteria:
* Parent or legal guardian is an Alexion employee.
* Any active or untreated thymoma. History of thymic carcinoma or thymic malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥5 years before Screening.
* History of thymectomy within 12 months prior to Screening.
* Are pregnant or lactating.
* Any unresolved acute, or chronic, systemic bacterial or other infection, which is clinically significant in the opinion of the Investigator and has not been treated with appropriate antibiotics.
* Use of PE within 4 weeks prior to first dose.
* Use of rituximab within 6 months prior to first dose.
* Patients who are under 15 kg and are receiving maintenance IVIg.
* Participation in another interventional treatment study or use of any experimental therapy within 30 days before initiation of study drug on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.
* Have previously received treatment with eculizumab or other complement inhibitors. |
Study Objectives
Bladder cancer (BC) as the most common malignancy arising from the urinary tract continues to be a major health problem. This prospective non-randomized study will enroll 150 patients undergoing magnetic resonance imaging (MRI) at different stages of their diagnostic and therapeutical process. The enrolled patients with suspected BC (BC) based on cystoscopy will have their initial MRI examination before transurethral resection of bladder tumor (TUR-BT) and biomarker collection. After pathology review of the histological specimens, patients will be treated according to standard clinical practice. The second MRI examination will be performed before therapeutic intervention, if TUR-BT alone is not sufficient enough. Neoadjuvant chemotherapy will be applied in high risk patients having muscle invasison, while intermediate risk patient - T1 high grade or carcinoma in situ patients - will be treated using Bacillus Calmette-Guerin (BCG) instilliations. After the completion of the neoadjuvant chemotherapy or BCG treatment, the patients will undergo the third MRI examination. Low risk patients will be followed by annual with MRI examination.
Intervention / Treatment
DEVICE: MR imaging
| Inclusion Criteria:
* Age: 18 to 85 years old
* Suspected BC based on cystoscopical evaluation.
* Mental status: Patients must be able to understand the meaning of the study
* Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff
Exclusion Criteria:
* History of serious cardiovascular, liver or kidney disease
* Uncontrolled serious infection
* Contraindications for MRI (cardiac pacemaker, intracranial clips etc)
* Patient refusing radical cystectomy or chemotherapy or BCG
* Intravesical Bacillus Calmette-Guerin instillations within 6 months before the first MRI examination |
Study Objectives
An early feasibility study to evaluate feasibility, radiotherapy benefits and safety when using TraceIT tissue spacer to create space between pancreas and duodenum in patients with localized Pancreatic Cancer.
Intervention / Treatment
DEVICE: TraceIT Tissue Spacer implantation
| Inclusion Criteria:
* Age ≥18 years old
* Biopsy-confirmed localized pancreatic cancer in the head or neck of the pancreas as defined by the NCCN guidelines
* Tumor is clearly delineable from duodenum and no clear evidence of invasion of the duodenum is seen at time of EUS performed for either diagnosis or fiducial placement.
* Subject is able to comply with motion management guidelines.
* Radiotherapy or chemoradiotherapy for treatment of the disease is indicated.
* In Investigator's opinion, medically fit to undergo endoscopy for fiducial marker implantation and TraceIT administration.
* Subjects Screening/Baseline laboratory testing must meet the following laboratory value criteria:
* White blood cell count: ≥ *0 x 109/L
* Absolute neutrophil count (ANC): ≥ *5 x 109/L
* Platelets: ≥ 100 x 109/L
* Total bilirubin: ≤ *0 times upper limit of normal (ULN)
* AST and ALT: ≤ *0 times institutional upper normal limit
* Serum creatinine: < *5 times ULN e
* INR: < *5
* Serum pregnancy: Negative
* Hemoglobin: ≥ *0 g/dl
* Zubrod Performance Status 0-2
* Subject or authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site.
* Life expectancy of at least 9 months
Exclusion Criteria:
* Patients for whom radiotherapy is contraindicated
* Previous thoracic or abdominal radiotherapy
* Any GI abnormality that would interfere with the ability to access the injection site
* Presence of tumor invasion of the duodenum detected on EUS at time of biopsy
* Previous Whipple procedure or other resection of pancreatic tumor prior to screening
* Active gastroduodenal ulcer or uncontrolled watery diarrhea
* History of Chronic Renal Failure.
* Documented history of uncontrolled diabetes (i.e., symptomatic hyperglycemia that cannot be medically managed, fasting blood glucose level above 300 mg/dL, and/or frequent swings between hyperglycemia and hypoglycemia)
* Currently enrolled in another investigational drug or device trial that clinically interferes with this study.
* Unable to comply with the study requirements or follow-up schedule.
* Any condition or comorbidity that the Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the subject.
* Women who are pregnant or breast-feeding; women of child-bearing age must use contraceptives. |
Study Objectives
A cross-sectional study on late effects after modern treatment in long-term survivors of head and neck cancer (HNC). Participants fill in questionnaires and participate at a one day visit at the hospital including blood sample with biomarkers, clinical examination, audiometry, oral radiological examination and oral examination. Data on patients' medical history collected from medical records including radiology images and digital radiotherapy plans.This will allow adjustments of treatment planning and improved treatment decisions for patients at risk, and improve information and follow up for future patients.
Intervention / Treatment
| Inclusion Criteria:
* Histologically or cytologically verified invasive carcinoma of the head and neck region; ICD10: C01, C*0 - C*9; C*0 - C*9; C*0 - C*9; C*0 - C*9; C*0 - C*9; C07; C*0 - C*9; C*0 - C*9; C*0 - C*9; C*0 - C*9; C12; C*0 - C*9; C*0 - C*9; C30; C*0 - C*9; C*0 - C*9, C*0
* Diagnosed 2006- 2012
* Ability to understand and respond to the questionnaires
* Ability to attend the clinical examination
* Informed consent received
Exclusion Criteria:
* Unwillingness to answer HRQL questionnaires
* Patients under ongoing treatment for secondary cancer or relapse at the time of the survey |
Study Objectives
The objective of this study was to prove the bioequivalence of Letrozole Tablet under fed conditions.
Intervention / Treatment
DRUG: letrozole, DRUG: letrozole
| Inclusion Criteria:
* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening
Exclusion Criteria:
* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to letrozole or any comparable or similar product. |
Study Objectives
This is an open-label, fixed-sequence study to evaluate the effect of capivasertib on the pharmacokinetics (PK) of midazolam, a sensitive CYP3A substrate. The PK of midazolam will be assessed when administered alone and in combination with repeated doses of capivasertib.
Intervention / Treatment
DRUG: Capivasertib, DRUG: Midazolam
| Inclusion Criteria:
* Participants with documented evidence of locally advanced inoperable or metastatic solid tumours who may be suitable to receive capivasertib treatment.
* Eastern Cooperative Oncology Group/World Health Organization performance status 0 to 1 and with minimum life expectancy for 12 weeks.
* Participant should have at least one lesion that can be assessed by computed tomography/magnetic resonance imaging or plain X-ray at baseline.
* Body mass index within the range 18 to 32 kg/m\^2
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
* Radiotherapy with a wide field of radiation within 4 weeks of the first dose of capivasertib and/or radiotherapy with a limited field of radiation for palliation within 2 weeks prior to study intervention initiation.
* Participants with diabetes mellitus type I or participants with diabetes mellitus type II requiring insulin treatment.
* Undergone a major surgery within 4 weeks of the first dose of capivasertib.
* Any unresolved toxicities from prior therapies higher than CTCAE grade 2 or any unresolved toxicity that may interfere with PK assessment at the time of study intervention initiation.
* Participants with spinal cord compression or brain metastases.
* Participants with severe or uncontrolled systemic diseases, active bleeding diatheses, or active infection.
* Previous allogeneic bone marrow transplant or solid organ transplant.
* Known immunodeficiency syndrome. |
Study Objectives
The aim of this study is to evaluate if the early change of needle during EUS-FNA for suspected pancreatic cancer allows an earlier preliminary cytological diagnosis of neoplasia.
Intervention / Treatment
PROCEDURE: Single needle, PROCEDURE: Multiple needle
| Inclusion Criteria:
* Suspicion of pancreatic mass due to previous exam/s (CT, MR, ERCP, US, ...) that requires EUS-FNA in order to complete diagnosis
* Age ≥ 18 y/o
* Formal informed consent
* No previous chemotherapy or radiotherapy
* No previous pancreatic surgery
Exclusion Criteria:
* Any patient unable to understand the procedure, nature of the current study, or sign a consent form. |
Study Objectives
To evaluate safety and efficacy of AIV001 treatment on low-risk basal cell carcinoma.
Intervention / Treatment
DRUG: AIV001
| Inclusion Criteria:
* Male or female, aged 18 to 80 years, inclusive
* No clinically relevant abnormalities identified by a detailed medical history and vital signs
* Presence of a histologically confirmed low risk BCC lesion, with well-defined borders, and with a largest diameter measure before biopsy of 5 mm to 20 mm, located on arms or trunk
* Histological diagnosis of the target lesion must have been conducted 5 to 30 days prior to Day 1
* No other dermatological disease within 50 mm of the target lesion at Day 1
* No prior or concurrent treatment of the target lesion (including radiation therapy)
* Willing to undergo surgical excision approximately 63 days after first treatment.
Exclusion Criteria:
* History or presence of systemic cancer
* Prior radiation treatment at the lesion site or anywhere else on the body within the past 20 years
* Concurrent disease or treatment that suppresses the immune system (eg, previous organ transplant history, etc.)
* Clinically relevant cardiovascular, endocrine, hepatic, neurologic, renal, or other major systemic disease that could complicate execution of the protocol or interpretation of the study results.
* History of thrombotic events, hemorrhagic events, and gastrointestinal perforation and fistula
* History of recurrence or presence of any other tumor subtype in the target lesion
* Concurrent presence of a malignant lesion within 100 mm of the target lesion that will require treatment during the study
* Current enrollment in any other investigational drug or device study within 60 days of Day 1 of this study
* Evidence of dermatological disease or confounding dermatological condition that would hinder carrying out the study or interpreting the results (eg, atopic dermatitis, eczema, psoriasis, xeroderma pigmentosa, etc.) |
Study Objectives
To evaluate online peer support and colorectal cancer screening behavior among individuals who are not currently meeting colorectal cancer screening guidelines. This is a randomized controlled trial.
Intervention / Treatment
BEHAVIORAL: Information + Narratives + Support Group, BEHAVIORAL: Information Only
| Inclusion Criteria:
* Age 50-75
* Not currently meeting colorectal cancer screening guidelines
* No previous colorectal cancer. |
Study Objectives
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Zoledronic acid may stop the growth of tumor cells in bone. Giving bevacizumab together with cyclophosphamide and zoledronic acid may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects of giving bevacizumab together with cyclophosphamide and zoledronic acid in treating patients with recurrent or refractory high-risk neuroblastoma.
Intervention / Treatment
DRUG: Bevacizumab, DRUG: cyclophosphamide, DRUG: zoledronic acid
| Inclusion Criteria:
* Patients must be no more 30 years of age when enrolled on study.
* Patients must have relapsed neuroblastoma, refractory neuroblastoma that had less than a partial response to standard treatment or persistent neuroblastoma that had at least a partial response to standard treatment.
* Patients who have at least a partial response to standard treatment who still have neuroblastoma that can be seen on CT/MRI or MIBG scans must have a surgical biopsy done of the tumor to confirm that it is neuroblastoma. Patients with relapsed or refractory neuroblastoma do not need to have a biopsy done to enter on study.
* Patients must have adequate heart, kidney, liver blood clotting and bone marrow function. Patients who have bone marrow disease must meet the bone marrow function criteria to enter the study.
* Patients must have recovered from all prior chemotherapy and surgical procedures
Exclusion Criteria:
* They are known to be sensitive to Bevacizumab.
* They have a history of very high blood pressure which required intensive intervention
* They are pregnant or breastfeeding
* Neuroblastoma is present in the brain on a CT or MRI scan done at study entry. Patients with neuroblastoma found in the bones of the skull are eligible if there is no tumor mass associated with them pressing on the brain.
* They have a history non healing wounds |
Study Objectives
This is a randomized multicenter open label phase III factorial trial evaluating the 3 years OS in patients with locally advanced squamous cell carcinoma of head and neck treated with locoregional treatment (radiotherapy plus concomitant chemotherapy or cetuximab) with or without neoadjuvant chemotherapy.
Intervention / Treatment
DRUG: RT+CDDP/5-FU, DRUG: RT+CETUXIMAB, DRUG: INDUCTION CTx(TPF)+(RT+CDDP/5-FU), DRUG: INDUCTION CTx(TPF)+(RT+CETUXIMAB)
| Inclusion Criteria:
* Histologically or cytologically proven squamous cell carcinoma of the head and neck.
* Primary tumor sites eligible : oral cavity, oropharynx, hypopharynx Although they are admittedly of squamous cell types, the following tumors will be excluded because of them responsiveness to chemotherapy: tumors of the nasal and paranasal cavities and of the nasopharynx.
* Stage 3 or 4 disease without evidence of distant metastases verified by chest X Ray, abdominal ultrasound, or CT (liver function test abnormalities); bone scan in case of local symptoms.
* At least one uni or bidimensionally measurable lesion.
* Tumor considered inoperable after evaluation by a multidisciplinary team (i.e. a surgeon, a medical oncologist and a radiation oncologist). Criteria for inoperability are:
* technical unresectability: tumor fixation/invasion to base of the skull or cervical vertebrae, involvement of the nasopharynx, and fixed lymph nodes.
* Physician decision based on low surgical curability. This category will include the following:
i) All T3-4 stages. ii) All N2-3 stages excluding T1 N* iii) Patients for organ preservation. Reason for inoperability will be recorded in the CRF.
* No previous chemotherapy or radiotherapy for any reason and no previous surgery for SCCHN (other than biopsy) are allowed at time of study entry.
* Age > 18 years.
* Karnofsky performance status > * (ECOG 0-1) (Appendix II)
* No active alcohol addiction.
* Life expectancy > 6 months.
* Signed informed consent prior to beginning protocol specific procedures.
* Adequate bone marrow, hepatic and renal functions as evidenced by the following:
a) Hematology (Bone marrow): i) Neutrophils > *0 109/L ii) Platelets > 100 x 109/L iii) Hemoglobin > 10 g/dL b) Hepatic function i) Total bilirubin < 1 x UNL ii) ASAT (SGOT) and ALAT (SGPT) < *5 x ULN iii) Alkaline phosphatase < 5 x ULN Patients with ASAT or ALAT > *5 x ULN associated with alkaline phosphatase > *5 x ULN are not eligible for the study.
c) Renal function : serum creatinine < 1 x UNL. In case of borderline value the creatinine clearance > 60 ml/min (calculated by the Cockcroft-Gault method as follows :
* Patients must be available for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating center.
-
Exclusion Criteria:
* Pregnant or lactating women or women of childbearing potential not using adequate contraception.
* Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin, or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years. Any prior treatment with radiotherapy or chemotherapy is an exclusion criterion.
* Symptomatic peripheral neuropathy > grade 2 by NCIC-CTG criteria
* Symptomatic altered hearing > grade 2 by NCIC-CTG criteria.
* Other serious illnesses or medical conditions including:
* Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry.
* History of significant neurologic or psychiatric disorders including dementia or seizures.
* Active uncontrolled infection.
* Active peptic ulcer.
* Hypercalcemia.
* Chronic obstructive pulmonary disease requiring hospitalization during the year preceding study entry
* History of hypersensitivity reaction to polysorbate 80 (Appendix IV)
* Patients requiring intravenous alimentation.
* Patients who experienced a weight loss of more than 20% of their body weight in the 3 months preceding study entry.
* Concomitant treatment with any other anticancer therapy.
* Participation in a therapeutic clinical trial within 30 days of study entry |
Study Objectives
The purpose of this study is to evaluate the efficacy and safety of 2 daratumumab treatment regimens in participants with multiple myeloma who have received at least 3 prior lines of therapy (including a proteasome inhibitor \[PI\] and immunomodulatory drug \[IMiD\]) or are double refractory to a PI and an IMiD.
Intervention / Treatment
DRUG: Daratumumab 16 mg/kg (Part 1), DRUG: Daratumumab 8 mg/kg (Part 1), DRUG: Methylprednisolone, DRUG: Acetaminophen, DRUG: Diphenhydramine, DRUG: Daratumumab (Part 2)
| Inclusion Criteria:
* Documented multiple myeloma according to protocol-defined criteria
* Evidence of disease progression on the most recent prior treatment regimen based on International Myeloma Working Group criteria
* Eastern Cooperative Oncology Group performance status score of 0, 1, or 2
* Laboratory values and electrocardiogram within protocol-defined parameters at screening
Exclusion Criteria:
* Received daratumumab or other anti-CD38 therapies previously
* Nonsecretory multiple myeloma
* Previously received an allogenic stem cell transplant or has received an autologous stem cell transplantation within 12 weeks
* Exhibiting clinical signs of meningeal involvement of multiple myeloma
* Known chronic obstructive pulmonary disease, persistent asthma, or a history of asthma within 5 years
* Seropositive for human immunodeficiency virus, hepatitis B or antibodies to hepatitis B surface and core antigens, or hepatitis C
* Has plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis |
Study Objectives
The purpose of this study is to determine the acute and late toxicities from radiation therapy in combination with bevacizumab (given every 2 weeks for 16 weeks then every 3 weeks for 12 weeks), bicalutamide (every day for 16 weeks) and goserelin (every 3 months for 2 years).
Intervention / Treatment
DRUG: bevacizumab, bicalutamide and goserelin, PROCEDURE: intensity modulated radiation therapy (IMRT)
| Inclusion Criteria:
* High Risk Prostate Cancer as defined as ONE of the following:
* Clinical T2b-T4
* Gleason sum score 8-10
* PSA more than 20 and Gleason sum score 7
* In addition, clinical T2a patients are eligible if 5 or more biopsies contain Gleason 4+3 cancer (minimum of 10 biopsies total required)
* No evidence of metastatic disease within 60 days of enrollment, confirmed by physical examination, chest x-ray, bone scan, and computed tomography of the abdomen and pelvis
* ECOG performance status of 0, 1 or 2
Exclusion Criteria:
* Concurrent or prior treatment with radiation, cytotoxic, biologic therapy for prostate cancer; any major surgery within four weeks, prior hormonal therapy (except finasteride for obstructive voiding symptoms)
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study; Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
* Presence of central nervous system or brain metastases
* Blood pressure of >150/100 mmHg
* History of myocardial infarction within 6 months
* History of stroke within 6 months
* Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study |
Study Objectives
Objective: This study demonstrated that the efficacy and safety of intrathecal(IT) rituximab in the treatment of stage Ⅲ and Ⅳ non-Hodgkin lymphoma(NHL) in children.
Methods: We reported 16 children were histologically diagnosed as stage Ⅲ and Ⅳ NHL from September 2015 to December 2020 who received IT rituximab in Pediatric Oncology of Sun Yat-Sen Memorial Hospital were restrospectively analyzed. The clinical manifestations, central nervous system involvement,treatment plan and prognosis of patients were analyzed....
ALL patients were pathologically positive for CD20 received the modified NHL-BFM 95, while IT rituximab was arranged the day before the chemotherapy, which was simultaneously used with the intravenous infusion of rituximab. The median time of doses received by each patient was 5 times, every three weeks, with the IT dose of 10 mg,15 mg, and 20 mg in increments.
Intervention / Treatment
OTHER: intrathecal rituximab
| Inclusion Criteria:
* Clinical diagnosis of B lymphocyte NHL
* Age≤ 18 years old
* Normal heart and kidney function
Exclusion Criteria:
* Heart, liver and kidney diseases
* Allergic to rituximab |
Study Objectives
Assess the long-term safety and efficacy of EN3835 in participants who have participated in a parent placebo-controlled study of EN3835 and assess the efficacy and safety of EN3835 in the treatment and retreatment of Plantar Fibromatosis.
Intervention / Treatment
BIOLOGICAL: EN3835
| Inclusion Criteria:
* Have been enrolled and completed a sponsored-clinical study of EN3835 (for the EN3835-222 study, participants who completed the study are those that completed the Day 57 visit, were assessed for safety and received at least 1 dose of study intervention).
* Willing and able to comply with all protocol required visits and assessments.
* Agree not to use opioids during the study period and has not used opioids 2 weeks prior to the Observational Day 1 Visit.
* Agree to not initiate or change use of orthotics or inserts designed to relieve symptoms of plantar fibromatosis during the study period.
* Willing and able to comply with all protocol required visits and assessments.
* Be adequately informed and understand the nature and risks of the study and be able to provide consent
* If female, be of non-childbearing potential (history of hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or postmenopausal with no history of menstrual flow in the 12 months prior to the Day 1 Visit), or, if of childbearing potential, be nonpregnant, non-lactating and agree to use effective contraception when with a male partner for the duration of the study and for 28 days after any active treatment period.
* Have no significant medical history or examination findings related to the participant's plantar nodules, which in the investigator's opinion, would make the participant unsuitable for EN3835 administration.
Exclusion Criteria:
* Has any musculoskeletal, neuromuscular, neurosensory, or other neurological or related disorder that affects the participant's use of his or her feet and/or would impair his/her completion of study assessments as determined by the investigator.
* Any other significant medical condition or had an SAE in the parent study which in the investigator's opinion, would make the participant unsuitable for enrollment in the study.
* Received or plans to receive surgical or non-surgical treatments on the foot or nodules that were treated.
* Has a known systemic allergy to collagenase or any other excipient of EN*
* Has a known bleeding disorder that would make the participant unsuitable for treatment or retreatment in the study.
* Has significant medical history or examination findings related to the participant's plantar nodules, which in the investigator's opinion, would make the participant unsuitable for EN3835 administration.
* Has a known coagulation disorder or is taking any medications that would increase the risk of bleeding (except <150mg of aspirin daily, 7 days prior to first injection and for the duration of the study. |
Study Objectives
A study to investigate which of two different tablet formulations of ODM-201 is best suited for use in the further development of the compound in the treatment of metastatic chemotherapy-naive castration-resistant prostate cancer. Patients successfully completing the bioavailability study will be able to receive further treatment with the current capsule formulation of ODM-201 until progression of their disease with the safety and tolerability of ODM-201 being assessed throughout.
Intervention / Treatment
DRUG: ODM-201 Tablet A, DRUG: ODM-201 Tablet B, DRUG: ODM-201 capsule formulation
| Inclusion Criteria:
* Written informed consent (IC) obtained.
* Histologically confirmed adenocarcinoma of prostate
* Progressive metastatic disease
* Ongoing androgen deprivation therapy with a luteinising hormone-releasing hormone (LHRH) analogue or antagonist or bilateral orchiectomy
* Adequate bone marrow, hepatic and renal function
* Able to swallow the ODM-201 whole as a capsule or tablet.
Exclusion Criteria:
* Previous chemotherapy for prostate cancer.
* Known metastases in the brain.
* History of other malignancy within the previous 5 years, except a basal cell carcinoma of skin.
* Known gastrointestinal condition that can significantly affect the absorption of the study treatment. |
Study Objectives
Japanese postmenopausal women in Japan have about one ninth the rate of American postmenopausal women. Rates of breast cancer double even after just ten years among Japanese women who migrate to the US. Diet is thought to be an important factor, and the investigators were interested in whether dietary seaweed, with and without soy supplements, could influence known biomarkers of breast cancer risk in American women.
Intervention / Treatment
DIETARY_SUPPLEMENT: Seaweed and Soy Protein, DIETARY_SUPPLEMENT: Placebo and Soy Protein
| Inclusion Criteria:
* Postmenopausal (self-reported cessation of menstruation 1 y prior to enrollment)
* If breast cancer survivor, all therapy completed at least 6 months prior to enrollment
* Agreed to eat their normal diet, avoiding seaweeds and phytoestrogen-rich foods,
* Restricting alcoholic intake to #2 drinks (24 g alcohol)/wk -Continuing habitual intake of vitamins, supplements, and medications during the study. -
Exclusion Criteria:
* No allergies to seaweed, soy, shellfish, or iodine
* No current use of tobacco;
* No thyroid dysfunction or treatment within the previous 5 y;
* Negative thyroid peroxidase antibodies as determined by screening;
* No hormone replacement therapy or for breast cancer survivors, no chemotherapy or radiation treatments within the preceding 6 mo
* No history of cancer (other than breast cancer)
* No current gastrointestinal disorders or diabetes; omnivorous eating habits, including meat and dairy products at least twice/wk
* No oral antibiotics, iodine containing medications, or corticosteroids treatment within the previous 3 mo. |
Study Objectives
Patients operated with posterolateral thoracotomy were enrolled. Post-operative analgesia was provided either by TEA with 0.1% bupivacaine or pethidine based intravenous analgesia (IVA) in our sample population. Perception of pain was quantified by Visual Analogue Scale (VAS) at rest and during coughing. Arterial blood samples were collected at 1st, 24th and 72nd hours of post-operative period. Pre-operative and post-operative 72nd-hour spirometric measurements were recorded
Intervention / Treatment
PROCEDURE: Thoracic epidural analgesia, DRUG: Bupivacaine
| Inclusion Criteria:
* American Society of Anesthesiologists -ASA- Class I to III)
* Scheduled for an elective thoracic surgical procedure with posterolateral thoracotomy
Exclusion Criteria:
* Individuals beyond defined age limits
* Having psychiatric problems
* Having an auditory deficit
* Active drug abuse
* Severe cardiovascular system disorders
* Severe respiratory depression depicted as having less than 50% of the predicted value of forced expiratory volume
* Refusing to give consent
* Contraindication to insertion of an epidural catheter. |
Study Objectives
Photodynamic therapy (PDT) is a palliative treatment for malignant biliary obstruction. The aim of this study is to assess the feasibility and safety of this technique in the context of a nationwide retrospective analysis.
Intervention / Treatment
PROCEDURE: Photodynamic therapy using polyhematoporphyrin
| Inclusion Criteria:
* Undergone photodynamic therapy as a treatment for malignant biliary obstruction.
Exclusion Criteria:
* None |
Study Objectives
The Response Evaluation Criteria in Solid Tumors (RECIST), based on differences in tumor size, has been considered as a reproducible method that facilitates not only the measurement of the mass but the evaluation of response to given treatments; while classic chemotherapy induces a reduction of the tumor, new target therapies frequently produce the stabilization of the disease or a delayed progression. These new therapeutic alternatives have shade light on the limitations of the RECIST criteria, since the response to these type of treatments are basically associated with changes on the radiological characteristics of the tumor, as well as other findings in functional imaging.
This study is aimed to compare the response rates according both Choi and RECIST criteria.
Intervention / Treatment
| Inclusion Criteria:
* Patients with a pancreatic neuroendocrine tumor with a Ki67 index <20%, who accept to participate and sign the consent form. In case of death patients, waiver of consent has been considered.
* Patients who, according daily clinical practice, have been treated with sunitinib between February 2012 to end of inclusion period, with a follow up of at least 6 months.
* Patients with a baseline imaging study (TC with arterial phase) and, at least, a 6-months follow-up evaluation. Patients with progression or exitus before the first imaging evaluation will not be included.
Exclusion Criteria:
* Patients with a follow-up of <6months because of any other cause beyond progression of disease or exitus.
* Patients without a baseline radiological evaluation or at 3/6 months.
* Patients who do not accept to participate in the study.
* Patients with anti-angiogenic treatment within 3 months prior to the start of sunitinib treatment.
* Patients treated with sunitinib plus any other anti-proliferative agent beyond ASS. |
Study Objectives
The main purpose of this study is to research the comparative effectiveness of two potential models of health care to deliver preventive services and chronic care management to the growing population of adult and pediatric survivors of childhood cancer. The central hypothesis is that survivorship care delivered by a subject's primary care doctor after the subject is empowered with individualized follow-up recommendations prepared by a cancer survivor specialist is similar to care provided in a specialty survival clinic.
Intervention / Treatment
OTHER: empowered primary care model, OTHER: specialty survivor clinic
| Inclusion Criteria:
* Diagnosis of any malignancy at age <18 years and reported to Yale-New Haven Hospital or Connecticut Children's Medical Center (CCMC) tumor registry
* Currently alive and cancer-free
* Primary residence within approximately 100 miles of Yale-New Haven Hospital or CCMC
* ≥ 1 year status post completion of all cancer-related therapy
* Elapsed time of less than *0 years since diagnosis of malignancy
* Speaking and writing knowledge of English. For subjects <18 years, at least one parent must satisfy this requirement.
* No previous attendance at the Yale HEROS or CCMC Reach for the STARS survivorship clinics, or other specialty survivorship clinic
Exclusion Criteria:
* n/a |
Study Objectives
The purpose of the study is to determine the impact of a physical activity intervention on the self-management of fatigue in young adults receiving chemotherapy. Half of the participants will receive an intervention which includes education and resources to set physical activity goals and monitor progress toward goals.
Intervention / Treatment
BEHAVIORAL: Step-Up Intervention
| Inclusion Criteria:
* have a diagnosis of cancer;
* are within the first two months of a chemotherapy regimen that will last at least another 3 months;
* are ambulatory without assistance;
* have written consent from their physician to participate;
* have the ability to understand English;
* have access to a computer and the Internet.
Exclusion Criteria:
* symptoms of uncontrolled cardiopulmonary disease, neurological disease
* delayed wound healing
* high risk of bone fracture
* pre-existing peripheral neuropathy |
Study Objectives
This research study is studying a new anti-cancer drug durvalumab (MEDI4736) with or without another new anti-cancer drug Oleclumab (MEDI9447) before surgery for bladder cancer.
The drugs involved in this study are:
* Durvalumab (MEDI4736)
* Oleclumab (MEDI9447)
Intervention / Treatment
DRUG: Durvalumab, DRUG: Oleclumab
| Inclusion Criteria:
* For inclusion in the study patients must fulfil all of the following criteria: Written informed consent and any locally-required authorization (e.g. HIPAA) obtained from the patient prior to performing any protocol-related procedures, including screening evaluations
* Age > 18 years at time of study entry
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (See Appendix A).
* Histologically confirmed bladder transitional cell carcinoma (TCC)
---Patients with mixed histology are required to have a component of TCC, and no component of small cell histology
* T2-T4a N0 M0 disease, considered appropriate and planned for radical cystectomy
* Ineligible for cisplatin-based chemotherapy, defined by any of the following:
* Creatinine clearance (CL) <60 mL/min. GFR should be calculated from serum/plasma creatinine using the Cockcroft-gault formula.
* CTCAE v*0 Grade > 1 hearing loss
* CTCAE v*0 Grade > 1 neuropathy
* NYHA Class > II cardiac dysfunction
* Patients not meeting the above criteria are eligible if she/he declines perioperative cisplatin-based chemotherapy after specific informed consent describing the known benefits of cisplatin-based chemotherapy.
* Adequate organ function laboratory values as defined below:
* Hemoglobin ≥ *0 g/dL
* Absolute neutrophil count (ANC) *5 x (> 1500 per mm3)
* Platelet count ≥100 x 109/L (>75,000 per mm3)
* Albumin > *5 g/dL
* International Normalized Ratio (INR) or activated partial thromboplastin time (aPTT) < *5 x ULN, unless the patient is receiving anticoagulation therapy provided INR or PTT is within the therapeutic range of the intended anticoagulant therapy.
* Serum bilirubin ≤*5 x institutional upper limit of normal (ULN)
---This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
* AST (SGOT)/ALT (SGPT) ≤*5 x institutional upper limit of normal
* Measured creatinine CL >30 mL/min or Calculated creatinine CL>30 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:
* Males:
* Creatinine CL (mL/min) = Weight (kg) x (140 - Age) 72 x serum creatinine (mg/dL)
* Females:
* Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x *85 72 x serum creatinine (mg/dL)
* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
* Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the postmenopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
* Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiationinduced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
* 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.
* Availability of baseline archival tumor tissue obtained for correlative studies dated within 8 weeks of study registration.
* Either FFPE tumor tissue block or a minimum of fifteen 5μm unstained FFPE slides and fifteen 10μm unstained FFPE slides with an associated pathology report is required.
* Patients without adequate baseline tumor tissue or have archival tumor tissue >8 weeks from registration must undergo cystoscopic tumor biopsy, meeting the above tissue criteria.
Exclusion Criteria:
* Patients with primary TCC of the ureter, urethra, or renal pelvis without TCC of the bladder
* Inoperable tumor(s) with fixation to the pelvic wall on clinical exam
* Any previous systemic chemotherapy or radiotherapy for TCC of bladder
* Participation in another clinical study with an investigational product during the last 6 months
* Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
* Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab
* History of another primary malignancy except for:
* Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study drug and of low potential risk for recurrence
* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
* Adequately treated carcinoma in situ without evidence of disease (e.g. cervical cancer in situ)
* Receipt of the last dose of intravesical chemotherapy or biologic therapy
≤ 42 days (6 weeks) prior to the first dose of study drug for patients who have received prior intravesical chemotherapy or biologic therapy (e.g. BCG)
* Mean QT interval corrected for heart rate using Fridericia's formula (QTcF)
≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart) for durvalumab + oleclumab cohorts only. Patient safety and the cardiac EKG should be consulted as needed.
* Any unresolved toxicity NCI CTCAE version *0 Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
* Patients with Grade ≥2 neuropathy will be evaluated on a case-bycase basis after consultation with the Study Physician.
* Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab and/or oleclumab may be included only after consultation with the Study Physician.
* Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g. hormone replacement therapy) is acceptable.
* Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
* History of allogenic organ transplantation
* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g. colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion:
* Patients with vitiligo or alopecia
* Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement
* Any chronic skin condition that does not require systemic therapy
* Patients without active disease in the last 5 years may be included but only after consultation with the study physician
* Patients with celiac disease controlled by diet alone
* Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
* History of leptomeningeal carcinomatosis
* Brain metastases or spinal cord compression. Patients with suspected brain metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry.
* History of active primary immunodeficiency
* Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
* Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug. The following are exceptions to this criterion:
* Intranasal, inhaled, topical steroids, or local steroid injections (e.g. intra articular injection)
* Systemic corticosteroids at physiologic doses not to exceed 10 mg/ day of prednisone or its equivalent
* Steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication)
* Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.
* Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of durvalumab
+ oleclumab or 90 days after the last dose of durvalumab monotherapy, whichever is the longer time period
* Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
* Prior randomization or treatment in a previous durvalumab and/or oleclumab clinical study regardless of treatment arm assignment
* Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements |
Study Objectives
The purpose of this study is to compare the effects of two specific exercise interventions and one standard care control arm on physical functioning.The investigators expect that supervised training is most beneficial to the patients. However, they also expect some benefit for patients in the home-based training.
Intervention / Treatment
BEHAVIORAL: Six months supervised resistance training, BEHAVIORAL: Six months home-based exercise training
| Inclusion Criteria:
* Pancreatic cancer patients (stage I-IV)
* Patients ≥ 18 years of age
* Resection performed at the University Clinic of Heidelberg
* Sufficient German language skills
* Signed informed consent
Exclusion Criteria:
* Presence of comorbidities that preclude participation in the intervention arms (e.g. severe pain, heart insufficiency, reduced standing or walking ability) |
Study Objectives
This phase I trial studies the side effects and best dose of everolimus when given together with anakinra or denosumab in treating participants with cancers that have spread to other places in the body and have come back or aren't responding to treatment. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Anakinra is designated to block a protein that is involved in tumor development, new blood vessels growing, and the spread of cancer. Monoclonal antibodies, such as denosumab, may interfere with the ability of tumor cells to grow and spread. Giving everolimus and anakinra or denosumab may work better in treating participants with advanced cancers.
Intervention / Treatment
BIOLOGICAL: Anakinra, BIOLOGICAL: Denosumab, DRUG: Everolimus
| Inclusion Criteria:
* Patients with advanced or metastatic cancers that are refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three months.
* Patients must be >= 3 weeks beyond treatment with a cytotoxic chemotherapy regimen, or therapeutic radiation, or major surgery. Patients may have received palliative localized radiation immediately before or during treatment provided that radiation is not delivered to the only site of disease being treated under this protocol. For biologic/targeted agents patients must be >= 5 half-lives or >= 3 weeks form the last dose (whichever comes first).
* Eastern Cooperative Oncology Group (ECOG) performance status =< *
* Absolute neutrophil count (ANC) >= 1,000/mL.
* Platelets >= 75,000/mL.
* Creatinine clearance >= 35 ml/min.
* Total bilirubin =< 2 X upper limit of normal (ULN) (exceptions may apply to benign non-malignant indirect hyperbilirubinemia such as Gilbert syndrome). Exception for patients with liver metastasis: total bilirubin =< 3 x ULN.
* Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) and or aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =< 5 X ULN. Exception for patients with liver metastasis: ALT (SGPT) =< 8 X ULN.
* Fasting lipid profile: cholesterol =< 350 mg/dL.
* Fasting lipid profile: triglycerides =< 400 mg/dL.
* Corrected calcium >= *4 mg/dL.
* Phosphorus >= *5 mg/dL for denosumab.
* Oral examination and appropriate preventive dentistry will be performed prior to the initiation of denosumab therapy.
* Negative tuberculosis quantiferon test for anakinra arm.
* Negative serology for histoplasma, blastomycosis, and Coccidioidomycosis for anakinra arm.
* Negative serology for active hepatitis B and C for anakinra arm. Patients with positive serology for hepatitis B might eligible if they are willing to take lamivudine preventive therapy.
* Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose.
* Patients must be able to understand and be willing to sign a written informed consent document.
Exclusion Criteria:
* Uncontrolled intercurrent illness, including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support. Treatment of pre-existing invasive fungal infections must be completed prior to starting treatment.
* Patients with an active infection.
* Pregnant or lactating women.
* History of hypersensitivity to anakinra.
* History of hypersensitivity to denosumab.
* History of hypersensitivity to everolimus.
* History of hypersensitivity to any component of the formulation.
* Patients unwilling or unable to sign informed consent document.
* Patients treated with TNF antagonists.
* Patients with a history of active systemic fungal infection.
* Patients with liver disease Child Pugh classification B and C. |
Study Objectives
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of tumor cells. Radiation therapy uses high-energy radiation from x-rays and other sources to kill tumor cells. Combining chemotherapy with interferon alfa and giving them with radiation therapy after surgery may kill any remaining tumor cells.
PURPOSE: Phase II trial to study the effectiveness of adjuvant chemoradiotherapy and interferon alfa in treating patients who have resected stage I, stage II, or stage III pancreatic cancer.
Intervention / Treatment
BIOLOGICAL: interferon-alfa-2b, DRUG: cisplatin, DRUG: 5-fluorouracil, RADIATION: radiation therapy
| Inclusion Criteria:
* Patient must be > 18 years of age.
* Patient must have a documented ECOG/Zubrod performance status of 0 or 1, within 7 days prior to registration.
* Patient must have pathological stage T1-3, N0-1, M0 adenocarcinoma of the head of the pancreas according to the American Joint Committee on Cancer (AJCC) staging system.
* NOTE: The pathology report must be submitted to ACOSOG on the Pathology Report Shuttle CRF.
* Patient must have undergone a potentially curative gross total resection by pancreaticoduodenectomy (includes R0 \[no residual tumor\] or R1 \[microscopic residual tumor\]) within 56 days prior to beginning treatment. NOTE: The operative report must be submitted to ACOSOG on the Operative Report Shuttle CRF.
* Patient must have stable or increasing weight in the 14 days prior to the start of treatment, otherwise supplemental nutrition (e.g. feeding jejunostomy, PEG, TPN) must be initiated prior to the start of treatment.* Patient must have adequate bone marrow, hepatic and renal function, within 7 days prior to registration:
* WBC > 3,000 mm\^3
* ANC > 1,500 mm\^3
* hemoglobin > *5 mg/dl
* platelet count > 100,000 mm\^3
* total bilirubin < 3 mg/dl
* AST (SGOT) < *0 times institutional upper limit of normal (ULN)
* ALT (SGPT) < *0 times institutional ULN
* alkaline phosphatase < *0 times institutional ULN
* serum creatinine < *5 times institutional ULN
* Patient must have a baseline diagnostic CT scan of the chest and CT scan with IV contrast (or MRI) of abdomen/pelvis, within 30 days prior to registration, to exclude metastatic disease.
* If female of childbearing potential, patient must have a negative urine or serum pregnancy test, within 7 days prior to registration. NOTE: Postmenopausal women must have been amenorrheic for at least 12 consecutive months to be considered not of childbearing potential.
* Patient (male or female) of reproductive potential must agree to use medically acceptable contraception during the study. NOTE: Medically acceptable contraceptives include: * surgical sterilization, * approved hormonal contraceptives (such as birth control pills, Depo-Provera, or Lupron Depot), * barrier methods (such as a condom or diaphragm) used with a spermicide, or * an intrauterine device (IUD).
* Patient, or the patient's legally acceptable representative, must sign and date an informed consent PRIOR to registration and the performance of any study related procedures.
* Patient, or the patient's legally acceptable representative, must provide written authorization to allow the use and disclosure of their protected health information.
* NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient prior to study registration.
* If patient is a cancer survivor, all of the following criteria must be met and documented in the patient's medical record:
* Patient has undergone potentially curative therapy for all prior malignancies.
* No evidence of prior malignancies for at least 5 years (except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, or nonmelanoma skin cancer).
* No evidence of recurrence of any prior malignancy.
Exclusion Criteria:
* Patient has pancreaticoduodenectomy histopathology of adenosquamous carcinoma, ampullary carcinoma, carcinoid tumor, cystadenocarcinoma, cystadenoma, distal common bile duct carcinoma, duodenal carcinoma, or islet cell carcinoma.
* Patient is pregnant or lactating.
* Patient has recurrent pancreatic cancer.
* Patient has received prior systemic chemotherapy or radiotherapy for pancreatic cancer.
* Patient has received external beam photon (x-ray) therapy to the chest, abdomen or pelvis.
* Patient has received any biologic/ immunologic therapies.
* Patient has received chronic immunotherapy (e.g. prednisone or methotrexate) for collagen vascular disease or other chronic immunologic abnormality.
* Patient has a preexisting psychiatric condition, especially depression, or a history of severe psychiatric disorders. |
Study Objectives
Taxotere has been approved by the FDA and is considered a standard treatment for patients with lung cancer who have failed prior platinum-containing regimens. The main purpose of this research study is to determine if Aptosyn, when given in combination with Taxotere, will result in prolonged survival when compared to Taxotere alone.
This study will also help determine tumor response rates, and the safety profile of Aptosyn in combination with Taxotere.
This study has been completed and a publication is pending.
Intervention / Treatment
DRUG: Exisulind
| Exclusion Criteria: |
Study Objectives
This phase II trial is studying the side effects and how well VEGF Trap works in treating patients with recurrent or persistent endometrial cancer. VEGF Trap may stop the growth of endometrial cancer by blocking blood flow to the tumor and by carrying tumor-killing substances directly to endometrial cancer cells.
Intervention / Treatment
BIOLOGICAL: ziv-aflibercept
| Inclusion Criteria:
* Histologically confirmed endometrial carcinoma, meeting both of the following criteria:
* Recurrent or persistent disease
* Refractory to curative therapy or established treatments
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* Tumors within a previously irradiated field are designated as nontarget lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days after completion of radiotherapy
* Must have received one prior chemotherapeutic regimen for management of endometrial carcinoma (initial treatment may include high-dose therapy, consolidation therapy, or extended therapy administered after surgical or non-surgical assessment)
* Not a candidate for a higher priority GOG protocol
* No history or evidence of primary brain tumor or brain metastases
* GOG performance status (PS) 0-2 (patients who received 1 prior regimen) OR GOG PS 0-1 (patients who received 2 prior regimens)
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Urine protein:creatinine ratio < *0 OR urine protein < *0 g by 24-hour urine collection
* Creatinine ≤ *5 times upper limit of normal (ULN)
* Bilirubin ≤ *5 times ULN
* SGOT ≤ *5 times ULN
* Alkaline phosphatase ≤ *5 times ULN
* PT/PTT/INR ≤ *5 times ULN
* In-range INR (between 2 and 3) allowed if patient is on a stable dose of therapeutic warfarin
* QTc < 500 msec
* No evidence of serious ventricular arrhythmia
* Ventricular tachycardia or ventricular fibrillation must be < 3 beats in a row
* LVEF normal
* Ejection fraction ≥ 50% (for patients who received prior anthracycline, including doxorubicin hydrochloride and/or doxorubicin hydrochloride liposome)
* No clinically significant cardiovascular disease, including any of the following:
* Uncontrolled hypertension, defined as systolic blood pressure (BP) > 140 mm Hg or diastolic BP > 90 mm Hg
* Myocardial infarction or unstable angina within the past 6 months
* NYHA class II-IV congestive heart failure
* Serious cardiac arrhythmia requiring medication
* Peripheral vascular disease ≥ grade 2
* Cerebrovascular accident (i.e., CVA or stroke), transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy
* No HIV positivity
* No neuropathy (sensory and motor) > grade 1
* No active infection requiring antibiotics
* No other invasive malignancies or any evidence of other cancer within the past 5 years except for nonmelanoma skin cancer
* No serious nonhealing wound, ulcer, or bone fracture
* No history of abdominal fistula or gastrointestinal perforation
* No history or evidence of seizures not controlled with standard medical therapy
* No intra-abdominal abscess within the past 28 days
* No active bleeding or pathologic conditions that carry a high risk of bleeding (e.g., bleeding disorder, coagulopathy, or tumor involving major vessels)
* No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
* No significant traumatic injury within the past 28 days
* No concurrent combination antiretroviral therapy for HIV-positive patients
* Recovered from prior surgery
* More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) or radiotherapy and recovered
* At least 1 week since prior hormonal therapy
* Concurrent hormone replacement therapy allowed
* At least 3 weeks since any other prior therapy, including immunologic agents
* One additional prior cytotoxic regimen for management of recurrent or persistent endometrial cancer allowed
* Cytotoxic regimens include any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa
* More than 28 days since prior major surgery or open biopsy
* More than 7 days since prior minor surgery, fine needle aspirates, or core biopsies
* No prior cancer treatment that would preclude study compliance
* No prior noncytotoxic chemotherapy for management of recurrent or persistent endometrial disease
* No prior VEGF Trap or other VEGF pathway-targeted therapy
* More than 5 years since prior radiotherapy to any portion of the abdominal cavity or pelvis except for the treatment of endometrial cancer
* More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin
* Patient must remain free of recurrent or metastatic disease
* More than 5 years since prior chemotherapy for any abdominal or pelvic tumor except for the treatment of endometrial cancer
* More than 3 years since prior adjuvant chemotherapy for localized breast cancer
* Patient must remain free of recurrent or metastatic disease
* Concurrent low-molecular weight heparin allowed for the prevention or treatment of venous thromboembolic disease if condition is considered clinically stable with treatment
* No other concurrent investigational agents
* No concurrent major surgery |
Study Objectives
This single arm study will assess the efficacy of Xeloda in the treatment of brain metastases in breast cancer patients with central nervous system (CNS) progression after whole brain radiotherapy. Patients will receive xeloda 1000mg/m2 po bid on days 1-14 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.
Intervention / Treatment
DRUG: capecitabine [Xeloda]
| Inclusion Criteria:
* female patients, >=18 years of age;
* breast cancer;
* CNS progression after radio-surgery + whole brain radiotherapy, or whole brain radiotherapy alone;
* at least one measurable lesion;
* ECOG performance status 0-*
Exclusion Criteria:
* prior systemic treatment of brain metastases;
* prior disease progression while on Xeloda treatment;
* previous history of cancer (other than curatively treated basal and squamous cell cancer of the skin or in situ cancer of the cervix) in previous 5 years;
* clinically significant cardiovascular disease. |
Study Objectives
This phase II trial is studying erlotinib hydrochloride to see how well it works in treating patients with advanced esophageal cancer or stomach cancer. Erlotinib hydrochloride may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth.
Intervention / Treatment
DRUG: erlotinib hydrochloride, OTHER: laboratory biomarker analysis
| Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma, squamous cell or small cell carcinoma, or carcinoma not otherwise specified of the esophagus or gastroesophageal junction
* Metastatic or surgically unresectable disease
* Measurable disease outside of primary tumor
* At least 20 mm by conventional techniques OR at least 10 mm by spiral computed tomography (CT) scan
* No bone metastases, abnormal radionuclide bone scans, or pleural effusions as only site of measurable disease
* No known brain metastases or carcinomatous meningitis
* Must consent to having tumor tissue tested for epidermal growth factor receptor status
* Performance status-Karnofsky 70-100%
* Life expectancy of greater than 3 months
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 2 times upper limit of normal (ULN)
* Aspartate aminotransferase (AST) no greater than 2 times ULN
* Creatinine no greater than *5 mg/dL
* Calcium no greater than 12 mg/dL
* No symptomatic hypercalcemia
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No ventricular arrhythmia
* No other malignancy within the past 3 years except adequately treated carcinoma in situ of the cervix, superficial transitional cell carcinoma of the bladder, or basal cell or squamous cell skin cancer
* No other uncontrolled concurrent illness
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study participation
* No other concurrent disease that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior cetuximab
* No more than 1 prior chemotherapy regimen for advanced or metastatic disease
* One prior chemotherapy in the adjuvant setting (in combination with prior surgery or radiotherapy) allowed provided it was administered prior to treatment for advanced or metastatic disease
* At least 3 weeks since prior chemotherapy
* No concurrent investigational or commercial chemotherapy
* At least 3 weeks since prior radiotherapy
* No prior erlotinib-related compounds or compounds of similar biologic or chemical components
* No prior EGFR-targeting compounds (e.g., gefitinib)
* No other concurrent investigational agents
* No concurrent combination antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients |
Study Objectives
Radiotherapy is a standard definitive treatment for men with localized prostate cancer.
Recent improvements in technology allow high doses of radiation to be delivered to the prostate in less days with lower doses to surrounding healthy tissues, trying to reduce side effects.
This study is being proposed to evaluate the use of moderate hypofractionated volumetric radiotherapy in localized prostate cancer patients and assessing treatment -related later adverse events using the CTCAE 4.0
Intervention / Treatment
RADIATION: Hypofractionated volumetric radiotherapy in 20 fractions
| Inclusion Criteria:
* Histologic confirmation of adenocarcinoma of the prostate by biopsy
* Performance Status 0-2
* Signed informed consent form
Exclusion Criteria:
* Positive lymph-nodes or metastatic disease from prostate cancer on imaging studies
* Anticoagulant treatment, individual assessment of antiplatelet therapy
* Previous pelvic radiotherapy
* Previous surgery for prostate cancer
* Previous transurethral resection of the prostate
* History of Crohn's Disease or Ulcerative Colitis
* Antecedents of rectal fistulas in the last 10 years
* Previous significant urinary obstructive symptoms
* Previous chemotherapeutic treatments
* Non-compliance with constraints established in this protocol (see special section |
Study Objectives
This multicenter, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and efficacy of RO5045337 in combination with doxorubicin in patients with soft tissue sarcoma. Cohorts of patients will receive escalating doses of RO5045337 orally on Days 1-5 (1-3) of each 28-day cycle in combination with doxorubicin 60 mg/m2 intravenously on Day 1 of each cycle for up to 6 cycles.
Intervention / Treatment
DRUG: RO5045337, DRUG: doxorubicin
| Inclusion Criteria:
* Adult patients, >/= 18 years of age
* Histologically or cytologically confirmed soft tissue sarcoma
* Evaluable disease according to RECIST version *1 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
* Eligible for doxorubicin therapy
* Acute toxicities from prior anti-tumor therapy, surgery or radiotherapy must have resolved to NCI-CTCAE Grade </= 1 prior to start of study
* Adequate bone marrow, hepatic and renal function
* Patients with stable CNS metastases are eligible
Exclusion Criteria:
* Previous treatment with limiting doses of doxorubicin
* Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy or other ailment </= 28 days from Day 1 dosing on study treatment
* History of seizure disorders or unstable CNS metastases
* Severe and/or uncontrolled medical conditions or other conditions that could affect the participation in the study
* Pregnant or breastfeeding women
* HIV positive patients who are currently receiving combination anti-retroviral therapy
* Patients with known coagulopathy, platelet disorder or history of non-drug induced thrombocytopenia
* Patients receiving oral or parenteral anti-coagulants/anti-platelet agents |
Study Objectives
The purpose of this study is to gain additional information regarding use of Magnetic Resonance Elastography (MRE) for uterine fibroid characterization. In this study, the investigators will use a new noninvasive technology, MRE, to further characterize the elastic properties of the uterine fibroids. To date, very little is known concerning how the tissue composition of the uterine fibroid may affect its treatment with Magnetic Resonance Guided Focused Ultrasound (MRgFUS).
In this study, the investigators will use a new noninvasive technology, magnetic resonance elastography (MRE), to further characterize the elastic properties of the uterine fibroids. This information will be gathered during routine magnetic resonance imaging for symptomatic uterine fibroids. It is known that some fibroids with increased T2-signal on Magnetic Resonance Imaging(MRI) can be more difficult to treat.
This information will be gathered during routine magnetic resonance imaging for symptomatic uterine fibroids.
Intervention / Treatment
RADIATION: MR Elastography
| Inclusion Criteria:
* Women able to give informed consent
* Women having uterine imaging
Exclusion Criteria:
* Women currently pregnant
* Allergy to either gadolinium or iodinated contrast
* Severe claustrophobia
* Weight in excess of 250 pounds |
Study Objectives
This phase II trial is studying how well giving doxorubicin together with bortezomib works in treating patients with liver cancer. Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving doxorubicin together with bortezomib may kill more tumor cells.
Intervention / Treatment
DRUG: doxorubicin, DRUG: bortezomib
| Inclusion Criteria:
* Patients must have microscopically confirmed hepatocellular carcinoma not amenable to curative resection; if patients have an isolated lesion in one lobe of the liver, a liver surgeon should determine resectability; central review is not required
* Patients must have measurable disease as determined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria, amenable to biopsy; patients are not mandated to allow biopsy, even though it is an important aspect of this clinical trial
* Patients with history of malignancy treated within the past 5 years are not eligible; history of carcinoma-in-situ of cervix, squamous cell cancer of skin, basal cell cancer of skin, previously treated are allowed; others are excluded as recurrence of disease may confuse response rate and/or survival endpoints
* Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Patients must not have had prior systemic chemotherapy for HCC; patients on antineoplastics for non-malignant diseases, such as methotrexate for rheumatoid arthritis, are allowed, providing patients have been off these agents for at least 4 weeks and all related toxicities have resolved to baseline
* Patients may have had prior embolization without chemotherapy; patients who have had chemoembolization are not eligible; patients may have had radiofrequency (RF) ablation, cryosurgery or ethanol injection; patients must have documented progression with the involved lesion or at least one previously untreated lesion amenable to biopsy
* Platelet count must be >= 100,000/mm\^3 in absence of splenomegaly; platelet count must be >= 75,000/mm\^3 with splenomegaly
* Absolute neutrophil count (ANC) must be >= 1,500/mm\^3 in absence of splenomegaly; ANC must be =< 1,000/mm\^3 with splenomegaly
* Alkaline phosphate (ALT) must be =< 5 x institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST) must be =< 5 x institutional ULN
* Bilirubin must be =< 2 mg/dl
* Patients may not exhibit Child Pugh scale grade C cirrhosis
* Serum creatinine=< *0 mg/dl
* All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
* Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception
* Patients must not have known bleeding diathesis, international normalized ratio (INR) > *5 or Partial thromboplastin time (PTT) > *5 x institutional ULN (required due to biopsy portion of study); use of vitamin K or fresh frozen plasma to correct values just prior to biopsy or enrollment is not allowed are not eligible
Exclusion criteria:
* Patients have baseline peripheral neuropathy > grade 1
* Patients with history of untreated malignancy other than HCC
* Patients have had prior use of octreotide or tamoxifen as therapy for HCC
* Patients with known allergy to boron, mannitol or bortezomib
* Women are pregnant or breast-feeding (due to the uncertain effects of bortezomib in the developing fetus and young infants)
* Patients have an underlying medical condition that precludes safe participation in this clinical trial
* Patients have psychiatric illness or continued substance abuse that may impair the ability to provide informed consent or prevent safe administration of bortezomib
* Patients with ejection fraction (EF) < 50% measured by Echocardiography (ECHO) or Multiple gated acquisition (MUGA)
* Patients on verapamil who cannot be switched to an alternative medication (due to the interaction with doxorubicin) |
Study Objectives
The primary purpose of this study is to investigate the safety and tolerability of a single dose of Cu-64 SARTATE and multiple doses of Cu-67 SARTATE administered to participants with meningioma. All participants in this study will be injected with a single dose of Cu-64 SARTATE to demonstrate how it is absorbed in the body. Then participants will receive individualised doses of Cu-67 SARTATE for up to 4 cycles.
Intervention / Treatment
DRUG: Cu-64 SARTATE and Cu-67 SARTATE
| Inclusion Criteria:
* Signed informed consent.
* Age greater than or equal to 50 years.
* Life expectancy greater than or equal to 3 months.
* Has adequate organ function as defined by the following laboratory values obtained within 28 days prior to administration of Cu-64 SARTATE:
* Estimated glomerular filtration rate (eGFR) greater than 40ml/min as measured using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than *0 x upper limit of normal (ULN).
* QT interval less than /=450msec as measured by 12 lead ECG.
* Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to *
* Diagnosis of recurrent or progressive histologically confirmed WHO grade I-III meningioma which has failed standard of care therapies. Patients will be considered to have failed standard care when they have disease that is progressing despite standard treatment (primarily radiotherapy) or where, in the opinion of their treating physician, further standard therapy is considered to be of sufficiently high risk of complication as to warrant consideration of alternate therapies.
* Male participants must agree to use contraception methods from Day 0 through to 4 weeks after the last dose of Cu-67 SARTATE.
* A female participant is eligible to participate if she is of:
* Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) greater than 40 MlU/ml and oestradiol less than 40 pg/ml (less than 140 pmol/l) is confirmatory\].
* Child-bearing potential and agrees to use contraception methods for an appropriate period of time (as determined by the Investigator) prior to Day 0 to sufficiently minimize the risk of pregnant females being enrolled. These measures are the combination of a barrier method AND established (greater than 2 cycles) hormonal methods (e.g. the oral contraceptive pill). Absolute sexual abstinence may be considered acceptable at the discretion of the investigator. Abstinence for the 12 days prior to therapy to allow for serum B-hCG assessment which should then ensure the patient is not pregnant prior to therapy administration.
* Female participants must agree to use contraception until four weeks after the last dose of Cu-67 SARTATE.
Exclusion Criteria:
* Known sensitivity or allergy to somatostatin analogues.
* Participants who have received interventional treatment for their meningioma within the four weeks prior to Day *
* Any major surgery within the four weeks prior to Day *
* Any additional planned interventions, including surgery or radiation therapy that would interfere with safety or efficacy assessments.
* Treatment with long acting somatostatin analogues within 28 days prior to Day * Treatment with short acting somatostatin analogues within 24 hours prior to Day *
* Any other malignancy in the past 5 years except for cervical intraepithelial neoplasia (CIN) of the cervix, squamous cell carcinoma (SCC) of the skin, basal cell carcinoma (BCC) of the skin or clinical insignificant prostate cancer not requiring prior therapy.
* Breastfeeding females and pregnant females.
* Treatment with any investigational agent received within four weeks prior to Day *
* Participants unwilling or unable to comply with protocol requirements.
* Urinary or faecal incontinence of sufficient degree to be of concern for contamination risk in the opinion of the Investigator.
* Peptide receptor radionuclide therapy (PRRT) at any time prior to enrolment in the study. |
Study Objectives
* This is a phase II, prospective, single-center, non-randomized, non-controlled study.
* Sentinel lymph node biopsy (SNB) is a standard staging procedure in early breast cancer. The potentially increasing false negative rate of SNB was concerned if the sonographic abnormal node was not excised. The aim of this study was to evaluate the accuracy of SNB in breast cancer with sonographic abnormal axillary lymph nodes.
Intervention / Treatment
PROCEDURE: Wire-localized abnormal node
| Inclusion Criteria:
* histologically confirmsed primary breast cancer by core neelde biopsy or excisional biospy
* abnormal axillary lymph node was found by ultrasound examination before SLNB (abnormal nodes were defined as completely hypoechoic node, asymmetric focal hypoechoic node, cortical lobulation and cortical thickness >3mm)
* ultrasound-guided FNA cytology of these nodes were performed
* the result of FNA cytology was negative (no tumour cell was found)
* patient planed to perform SLNB
Exclusion Criteria:
* pathological diagnosed ductal carcinoma in situ by excisional biospy
* abnormal axillary lymph node was found by ultrasound examination but FNA cytology of these nodes were not performed
* the result of FNA cytology was positive (tumour cell was found)
* T4d tumour
* patient has recieved neo-adjuvant system therapy |
Study Objectives
This is an open-label, study of MEDI9090 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of MEDI9090 in adult subjects with advanced solid tumors.
Intervention / Treatment
BIOLOGICAL: MEDI9090, BIOLOGICAL: Durvalumab
| Inclusion Criteria:
* Male and female subjects
* 18 years and older
* Must have histologic documentation of advanced solid tumors
* Must have received and have progressed, are refractory or, intolerant to standard therapy and must not have a curative therapy option
Exclusion Criteria:
* Concurrent enrollment in another clinical study
* Prior participation in clinical studies that include durvalumab alone or in combination
* Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment |
Study Objectives
This phase I study will evaluate the feasibility and toxicity of weekly bortezomib in the treatment of relapsed or refractory multiple Myeloma and determine whether a twice-weekly schedule of bortezomib is effective in producing responses in patients with stable disease or progression after weekly bortezomib
Intervention / Treatment
DRUG: Bortezomib
| Inclusion Criteria:
To be included in this study, you must meet the following criteria:
* Multiple Myeloma
* Received no more than 2 previous treatment regimens for multiple Myeloma
* ECOG performance status 0, 1, or 2
* Serum creatinine < *0mg/dL
* calculated or measured creatinine clearance > 30ml/minute
* Measurable or evaluable disease
* Provide written informed consent prior to receiving protocol therapy.
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
* Moderate or severe peripheral neuropathy
* Other serious medical conditions
* Other active malignancies
* history of treatment for other invasive cancers
* Women who are pregnant or lactating
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. |
Study Objectives
Background of the study:
Prediction of rectal tumor response after chemoradiotherapy (CRT) might be helpful in individualizing treatment strategies, i.e., selecting patients who need less invasive surgery or another radiotherapy strategy instead of resection. For rectal cancer it is known that 10-30% of the patients will respond with a pathologic complete response (pCR) after CRT. From a retrospective study with multivariate analysis of both clinical and 2-\[18F\] fluoro-2-deoxy-D-glucose and positron emission tomography (FDG-PET) data, it was found that adding FDG-PET data collected before and after CRT leads to a more predictive model compared to evaluating only pretreatment clinical data. To validate this model, this registration study is proposed. Furthermore, it has been found that FDG-PET during treatment is very predictive for response and a more favorable time point to adapt treatment. Also, there are indications that adding blood biomarkers to the data, results in higher accuracy for response prediction compared to clinical and imaging data alone. Therefore, FDG-PET during treatment and blood sampling are included in the protocol to improve the accuracy of the prediction models.
Objective of the study:
The long-term research objective is to be able to select rectum cancer patients who could receive a less invasive treatment. If prediction of response is possible, surgery may be avoided when complete response after chemoradiotherapy is expected or performed with smaller incisions if stage reduction is significant. This support decision system helps to individualize patient treatment and can improve the quality of life for the patient.
Study design:
28x radiotherapy. On day 15 of radiotherapy en 8 weeks after radiotherapy: 1 PET-CT scan Before radiotherapy, on day 15 and 8 weeks after radiotherapy: blood sample taken.
Intervention / Treatment
| Inclusion Criteria:
* Histological proven rectal cancer
* UICC stage I-III
* Only primary tumors; no recurrences
* Only concurrent chemoradiotherapy treatment
* Willing and able to comply with the study prescriptions
* 18 years or older
* Have given written informed consent before patient registration
* No previous radiotherapy to the pelvis
Exclusion Criteria:
* No adenocarcinoma histology
* History of prior pelvis radiotherapy |
Study Objectives
Persistent smoking after lung cancer has been the subject of medical, therapeutic and epidemiological publications for twenty years of research. Continued persistent smoking is all the more a problem for oncologists as there is evidence that smoking cessation, with lung cancer, gives therapeutic benefit. Quitting smoking can improve the response to treatments (chemotherapy, radiotherapy, surgery), quality of life and overall survival. However many patients refuse adhesion to tobacco cessation. Daily practice leads us to the hypothesis that adhesion differences aren't related to the denial of medical information, nor to resignation or to nicotine dependence. Patients who continue smoking seem to face a form of impossibility to wean. Cigarette seems to be felt as a part of their body in their narration and description of their body image.
Intervention / Treatment
BEHAVIORAL: Research interviews, BEHAVIORAL: Tests (Fagerström, Q-MAT, H.A.D.S, SCL 90-R), BEHAVIORAL: Projective methods (Thematic apperception Test, Rorschach), BEHAVIORAL: Carbon monoxide test
| Inclusion Criteria:
* Men and women aged 18 years or older
* Patient affiliated to a social security system
* Patient who has signed and dated informed consent, written before all procedures related to the study
* Patient who has received the results of the previous mandatory medical examination
* Patient who has been diagnosed with lung cancer, regardless of the histological type of the cancer
* Patient who maintains an active smoking at the time of inclusion
* Patient who has smoked at least one cigarette in the previous year of inclusion
* Patient who is being treated for lung cancer (surgery, chemotherapy, radiotherapy) and not another form of cancer
* Tobacco consumer's only by smoke inhalation
* Tobacco consumer's or tobacco associated with cannabis
Exclusion Criteria:
* Major patient under guardianship or curatorship or maintenance of justice
* Patient deprived of his liberty or in an emergency situation
* Patient with a Performance Statut(OMS) higher than 2 and/or with a psychiatric disorder like " schizophrenia and other psychotic disorders " (DSM IV)
* A palliative care patient
* Patient who began smoking during his diagnostic examination or after the diagnosis of cancer
* A pregnant or breastfeeding woman
* Patient in an exclusion period |
Study Objectives
The purpose of this research study is to compare the effectiveness and safety of FKB238 against Avastin® in men and women with advanced/recurrent non squamous non-small cell lung cancer
Intervention / Treatment
DRUG: FKB238 (bevacizumab), DRUG: Avastin (bevacizumab), DRUG: Paclitaxel, DRUG: Carboplatin
| Inclusion Criteria:
* Patients aged 18 years or older
* Newly diagnosed advanced (stage IV) /recurrent non-squamous NSCLC for which they had not received any systemic anti-cancer therapy for metastatic disease
* Histologically or cytologically confirmed diagnosis of predominantly non-squamous NSCLC
* Existence of at least 1 measurable lesion by RECIST v*1
* Adequate hematological, renal and liver function
* Eastern Collaborative Oncology Group Performance Status (ECOG PS) 0 or 1
* Life expectancy longer than 6 months
Exclusion Criteria:
* Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature
* Any unresolved toxicities from prior systemic therapy
* Known sensitizing epidermal growth factor receptor (EGFR) mutations or echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase (EML4-ALK) translocation positive mutations
* Previous dosing with vascular endothelial growth factor (VEGF) inhibitor
* Known hypersensitivity to any excipients of the Investigational Products (IPs) and combination chemotherapy
* Use of prohibited concomitant medication
* Known Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection
* Fertile men or women of childbearing potential not using adequate contraception.
Other inclusion/exclusion criteria may apply. |
Study Objectives
Conventional transarterial chemoembolization with Doxorubicin (c-TACE) is the gold standard treatment for Hepato Cellular Carcinoma (HCC) stage B (BCLC) / stages A and B (Child-Pugh). Clinical recommendations for cTACE indicate that the doxorubicin solution may be reconstituted in either aqueous solution or iso-osmolar ionic iodinated contrast media. There is no consensus on which solvent should be used. Hence, the clinical evaluation of Lipiodol cTACE would benefit from a standardization in the reconstitution of the drug. In this study, the comparison of the kinetics of distribution of the drug within the tumor micro-environment is expected to allow for comparison of drug solvents.
This pilot study aims at evaluating the kinetics of distribution of the drug within the tumor micro-environment, for the two main solvents used in reconstituting the drug, namely normal saline and contrast media. The kinetics of distribution in the tumor will be evaluated primarily through regular biopsy sampling, and secondary with confocal laser endomicroscopy.
Intervention / Treatment
DRUG: Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc iso-osmolar ionic iodinated contrast media, DRUG: Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc normal saline
| Inclusion Criteria:
* Adult (>18)
* Informed consent
* CHC Child-Pugh stage A or B, BCLC stage B
* Referred for chemoembolization of a non-surgery-candidate CHC
* Blood test results compatible with cTACE (INR ≤ 1,5, ASAT/ALAT<5N, albumine>2,5g/dl)
Exclusion Criteria:
* Contraindication to cTACE, angiography, confocal laser endomicroscopy or liver biopsy Hyperthyroidism
* Contraindication to the use of fluorescein, Ariblastine,Lipiodol, Visipaque, Gelita spon, Avitene
* extra hepatic metastasis
* Subcapsular or exophytic tumor impeding direct percutaneous access through healthy liver tissue
* Waiting list for liver transplant
* Complete portal venous thrombosis or flow inversion
* Pregnancy or breast feeding
* Protected major (Guardianship)
* Patient in situation of exclusion (determined by a previous or ongoing study)
* Subject incapacity to understand informed consent |
Study Objectives
This study evaluates the safety associated with the addition of sulfasalazine to stereotactic radiosurgery for recurrent glioblastoma. Sulfasalazine is a potential tumor selective radiosensitizer.
Intervention / Treatment
DRUG: Sulfasalazine
| Inclusion Criteria:
* Histologically verified glioblastoma multiforme with recurrence (first or second relapse, all subtypes) based on the Response Assessment in Neuro-Oncology criteria.
* Prior standard therapy for newly diagnosed glioblastoma consisting of surgery, standard fractionated radiotherapy to 60 Gy concomitant with Temozolomide
* Has been informed of other treatment options
* Must be eligible to gamma knife treatment
* Tumor size ≤ 3 cm in diameter (≤ 15 cm3 ) on MRI dated no more than 30 days before SRS treatment
* Must be at least 18 years of age
* Must be ambulatory with a Karnofsky performance status of ≥ 70
* Life expectancy > 12 weeks
* Laboratory parameters for vital functions should be in the normal reference range. Laboratory abnormalities that are not clinically significant are generally permitted, except for the following laboratory parameters, which must be within the ranges specified:
Hematology: White blood cell count: ≥ *0 x 109/l, Platelet count:: ≥ 100 x 109/l, Hemoglobin: ≥ 100 g/l, Total bilirubin level: <*5 times the upper limit of normal (ULN) (except in patients with Gilbert's Syndrome who must have a total bilirubin less than 51,3 µmol/L), alanine aminotransferase < 3 times the ULN, Creatinine < *5 times the ULN, Normal prothrombin time / international normalized ratio (PT INR) < *4, Absolute neutrophil count: ≥ 1 x109/L without the support of filgrastim.
* More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a grade 1 or less. Patients may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to grade 1 or less or as specified in the eligibility criteria.
* Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to national/local regulations
Exclusion Criteria:
* Allergy to sulfa drugs
* Adverse reactions to salicylates
* Known hypersensitivity to sulfasalazine, its metabolites or any of the excipients (Povidone; Maize starch; magnesium stearate; colloidal silicon dioxide)
* Eligible to alternative standard treatments with temozolomide
* Treatment with sulfasalazine after glioblastoma diagnosis
* Participation in pharmacokinetic trial within 4 weeks
* Participation in immunotherapy trial within 4 weeks
* History of psychological symptoms affecting ability to consent to and/or fulfill the protocol
* Other malignant diseases and multiple sclerosis
* Pregnant or breast feeding patients.
* Porphyria
* Kidney of liver deficiencies
* Glucose-6-phosphate dehydrogenase deficiency
* Severe allergy or bronchial asthma
* History of erythema multiforme
* Significant heart failure or renal failure
* Intestinal or urinary obstruction
* Any reason why, in the opinion of the investigator, the patient should not participate (e.g. not able to comply with study procedures). |
Study Objectives
This is a Phase I/IIa, open-label study to evaluate the safety, tolerability, and immunogenicity of INO-3112 DNA vaccine delivered by electroporation (EP) to participants with human papilloma virus (HPV) associated head and neck squamous cell cancer (HNSCC).
Intervention / Treatment
BIOLOGICAL: INO-3112, DEVICE: CELLECTRA™-5P
| Inclusion Criteria:
* Signed and dated written Ethics Committee approved informed consent.
* Age ≥18 years.
* Histologically confirmed HPV-positive (as assessed by p16 IHC or oncogenic HPV ISH or PCR) mucosal squamous cell head and neck cancer:
* For pre-surgical participants, p16 positivity must be confirmed prior to the first dose.
* For participants post-chemoradiation, HPV 16 and HPV 18 positivity must be confirmed prior to the first dose.
* Adequate bone marrow, hepatic, and renal function. ANC (Absolute Neutrophil Count) ≥ *5x109 cell/ml, platelets ≥75,000 cells/mm3, hemoglobin ≥*0 g/dL, concentrations of total serum bilirubin within *5 x upper limit of normal (ULN), (Aspartate Aminotransferase) AST, (Alanine Aminotransferase) ALT within *5x institutional ULN, (Creatine Phosphokinase) CPK within *5 x ULN.
* ECOG (Eastern Cooperative Oncology Group) performance status of 0-*
Exclusion Criteria:
* Anticipated concomitant immunosuppressive therapy (excluding non-systemic inhaled, topical skin and/or eye drop-containing corticosteroids).
* Any concurrent condition requiring the continued use of systemic steroids (>10 mg prednisone or equivalent per day) or the use of immunosuppressive agents. All other corticosteroids must be discontinued at least 4 weeks prior to Day 0 of treatment.
* Administration of any vaccine within 6 weeks of enrollment. |
Study Objectives
What is the efficacy and safety of q 30 minutes vs. q 1hour glucose sampling and intervention for an intensive insulin protocol to achieve and maintain euglycemia in non-diabetic patients undergoing craniotomy? The investigators hypothesize that in non-diabetic patients undergoing craniotomy, monitoring glucose and modifying insulin infusions every 30 minutes compared to every hour will help them reach target glucose levels faster and maintain them more efficiently with the same insulin protocol.
Intervention / Treatment
DRUG: Insulin
| Inclusion Criteria:
* All English speaking, non-diabetic, non-pregnant patients over the age of 18 undergoing open craniotomy for the surgical treatment of tumors or intracranial aneurysms.
Exclusion Criteria:
* Patients under 18 years of age, patients who are pregnant, patients with diabetes, BMI > 33 kg/m* |
Study Objectives
B cell malignancies comprise a heterogeneous group of neoplasms including a vast majority of non-Hodgkin's lymphomas (NHL), lymphoblastic leukemias (ALL) and chronic lymphocytic leukemias (CLL). Current treatments for B cell malignancies include chemotherapy, radiation therapy, bone marrow transplantation, and peripheral blood stem cell transplantation. Despite these treatment modalities, most patients will remain incurable. Welgenaleucel (UWC19) is a CD19-directed genetically-modified autologous immunotherapy. This study is designed to evaluate safety and feasibility of administering Welgenaleucel (UWC19) transduced with anti-CD19 lentiviral vector to patients with advanced refractory hematologic malignancies, including DLBCL and ALL.
Intervention / Treatment
GENETIC: Welgenaleucel
| Inclusion Criteria:
* CD19+ leukemia or lymphoma patients with no available curative treatment options who have limited prognosis with currently available therapies
* Absolute lymphocyte count, ALC )≧600/μl
* HIV, HTLV, Syphilis negative
* GPT ≦200 U/L
* Cr ≦221 umol/L
* Adequate venous access for apheresis, and no other contraindications for leukapheresis.
* Voluntary informed consent is given.
Exclusion Criteria:
* Body weight < 20Kg
* Pregnant women.
* Uncontrolled active infection.
* Active hepatitis B or hepatitis C infection.
* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
* Previously treatment with any gene or cell therapy products.
* Any uncontrolled active medical disorder that would preclude participation as outlined.
* Expected survival< 12 weeks
* Received investigational drug or device within 30 days pre-trial;
* Patients with any other serious diseases considered by the investigator(s) not in the condition to enter the trial. |
Study Objectives
Prostate specific membrane antigen (PSMA) is a unique membrane bound glycoprotein, which is overexpressed on prostate cancer cells and is well-characterized as an imaging biomarker of prostate cancer. Studies have shown that PSMA PET/CT can detect prostate cancer lesions with excellent contrast and a high detection rate even when the level of prostate specific antigen is low. PSMA imaging is considered the gold standard in imaging of biochemical recurrence, with detection rate of recurrence in 79.5% of patients, in the largest series of 1007 patients. Despite these excellent results, there remains approximately 20% of patients in whom the site of biochemical recurrence cannot be identified and further research is needed into improving detection rates.
Androgen deprivation therapy (ADT), represents the standard of care treatment for most men with a rising serum PSA and no evidence of disseminated disease on imaging modalities. There has been some preliminary data that imaging patients early after initiation of ADT therapy may increase detection rates of recurrence sites.
The objective of this study is to evaluate if prostate cancer patients with biochemical recurrence and negative PSMA PET/CT can demonstrate in-vivo upregulation of PSMA receptors in an attempt to improve detection rates of recurrent prostate cancer. Patients who are started on ADT when clinically indicated, will have repeat PSMA PET/CT at 4 weeks following initiation of ADT therapy.
Intervention / Treatment
DIAGNOSTIC_TEST: PSMA PET/CT
| Inclusion Criteria:
* Male sex
* Age 18 years or older
* Previous diagnosis of prostate cancer following radical prostatectomy or primary radiation therapy, with biochemical recurrence.
* Prior negative PSMA PET/CT within 2 months prior to study entry
* ECOG performance status 0 - 3, inclusive
* Able to understand and provide written informed consent
* Initiation of androgen deprivation therapy within 5 weeks prior to study PSMA PET/CT
* Able to tolerate the physical/logistical requirements of a PET/CT scan
Exclusion Criteria
* Medically unstable patients
* Patients who exceed the safe weight limit of the PET/CT bed (200 kg) or who cannot fit through the PET/CT bore (70 cm diameter)
* Patients with unmanageable claustrophobia |
Study Objectives
This study will compare the efficacy and safety of escalating versus standard doses to rash of Tarceva, in combination with gemcitabine, in patients with metastatic pancreatic cancer. During a 4 week run-in period, all patients will receive Tarceva 100mg/day po plus gemcitabine 1000mg/m2 iv on days 1, 8,15 and 22. After 4 weeks, patients who have not developed rash, or only develop grade 1 rash, will be randomized to one of 2 groups. Group 1 will receive a starting dose of Tarceva 150mg po daily, increased in steps of 50mg every 2 weeks up to a maximum of 250mg/day po, until development of grade 2 rash or other dose-limiting toxicity. Group 2 will continue to receive Tarceva 100mg/day po. All patients will continue to receive gemcitabine 1000mg/m2 iv on days 1, 8 and 15 of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Intervention / Treatment
DRUG: Erlotinib, escalating dose, DRUG: Erlotinib, standard dose, DRUG: Gemcitabine
| Inclusion Criteria:
* adult patients, >=18 years of age;
* histologically or cytologically confirmed pancreatic cancer with measurable or non-measurable metastatic disease;
* ECOG performance status of 0-*
Exclusion Criteria:
* local, or locally advanced, pancreatic cancer;
* prior systemic treatment for metastatic pancreatic cancer;
* <=6 months since last adjuvant chemotherapy;
* other malignancies within last 5 years, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer. |
Study Objectives
Pioglitazone, an agonist of the peroxisome-proliferator-activated receptor (PPAR), is a relatively new oral anti-hyperglycemic drug. Since its first approval in the USA in 1999, a potential link with bladder cancer has been a subject of debate. US Food and Drug Administration (FDA) in September, 2010 and European Medicines Agency in July, 2011 issued an alert about a potential relation between the occurrence of bladder cancer and the prescription of pioglitazone, based on the data from various studies. France banned its use in July 2011.
Recently Pioglitazone was banned from India without any evidence of increased bladder cancer in our population. With this background, we plan to study the risk of bladder cancer in male type 2 diabetes subjects aged more than 50 years who are on pioglitazone therapy as compared to never-users of pioglitazone in a retrospective cohort design and provide the first data from India to the policy makers regarding the purported risk in our ethnicity and geographical area.
Intervention / Treatment
DRUG: Pioglitazone
| Inclusion Criteria:
* Male Type 2 diabetes subjects with age >50 year
* On anti-diabetic drugs and/or insulin for≥ 1 year
* Patient willing to provide informed consent to be included in the study
Exclusion Criteria:
* * Bladder cancer diagnosed before the onset of Diabetes mellitus. * Patient not willing to participate in the study. |
Study Objectives
This study aimed to develop a novel Prognostic Oxidative Stress-Immune-Inflammatory Score (POSII Score) and introduce an innovative online calculator designed to predict long-term survival and assess the recurrence risk of gastric cancer (GC).
Intervention / Treatment
| Inclusion Criteria:1) histopathologically diagnosed gastric adenocarcinoma, 2) undergoing radical gastrectomy for GC, 3) absence of tumor invasion into adjacent organs or distant metastasis, and 4) availability of complete laboratory data.
Exclusion Criteria: 1) non-adenocarcinoma gastric cancers, 2) gastric stump cancer, 3) receipt of neoadjuvant therapy, 4) a history of other malignancies, and 5) insufficient clinical data or follow-up information. |
Study Objectives
The objective of the study was to compare the therapeutic benefit of capmatinib versus appropriate comparative therapy (ACT) defined by the German HTA agency G-BA for its benefit assessment of capmatinib but also versus the standard of care (SoC) practiced in German routine care. Due to its design as an adjusted, patient-level comparison, the RECAP study addresses the evidence gap due to the single-arm nature of pivotal evidence for capmatinib.
For this purpose, data on patients treated with ACT resp. SoC in German routine care has been collected via a retrospective chart review. This data was then used as an external control for a non-randomized, patient-level adjusted comparison with data from the GEOMETRY mono-1 study of capmatinib (NCT02414139).
Due to the non-interventional nature of this study, the definition of endpoints as primary or secondary was omitted formally.
Intervention / Treatment
| Inclusion criteria
* NSCLC (any histology)
* METex14 mutation
* Epidermal Growth Factor Receptor (EGFR) wildtype
* Anaplastic lymphoma kinase (ALK) rearrangement negative
* Stage IV or Stage IIIB without indication for local therapy
* First or second line of treatment
* Age ≥18 years Exclusion criteria
* Prior treatment with crizotinib, capmatinib, tepotinib or other MET inhibitors
* Carcinomatous meningitis
* Symptomatic brain metastases
* Eastern Cooperative Oncology Group Status (ECOG) >1
* Uncontrolled, clinically significant heart diseases
* Malignant disease other than NSCLC within the past 3 years |
Study Objectives
In response to Program Announcement (PA)-09-164, "NIH Exploratory/Developmental Research Grant Program (R21) a randomized pilot study testing the efficacy of SWIFT: Social Work Intervention Focused on Transitions among at-risk older adults following hospital discharge to home. This study is drawn from several observations. First, transitions between care settings create elevated risk for poor outcomes and for readmission among older adults leaving the hospital for home largely due to fragmented care and poor communication. Next, while few studies exist that test methods to improve transitions, those available are largely medically focused, using a nurse or advanced practice nurse in their approach. Although evidence exists to support the effectiveness of these models, few have been replicated and none have been integrated into standard health care practice. This may be attributed to several factors including the availability of the needed staff, the lack of existing structures to support these roles, and the costs of implementing these interventions. Finally, a social work driven intervention may provide a replicable mechanism for bridging medical care, addressing psychosocial needs as well as medical needs, and improving linkages with community services while reducing care duplication. This study aimed to test a structured social work transition intervention model to reduce rates of hospital readmission and medical service use while improving patient satisfaction with the care transition process. A randomized pilot study was used to test a social work transitions model designed to improve care provided to frail older adults being discharged from the hospital to return to the community. Eligible patients consenting to participate (n=181) were randomly assigned to either the social work transitions model intervention or usual care. This project was conducted at Huntington Hospital, a 525-bed, nonprofit, community hospital located in Pasadena, California. In an average year, Huntington Hospital has approximately 10,000 older adults discharged from their facility, 44% of who are 80 years old or older. Those randomized to the intervention arm received up to six sessions from the social worker, at least one provided in the home. The social work intervention was designed to overcome common problems following hospital discharge including medication review, discussion and planning around discharge instruction, assistance in scheduling follow up appointments, assessments of psychosocial and other support service needs and provision of linkages to address those needs. Outcomes were measured three and six months following arrival at home, with an interim measure of satisfaction at 10 days following arrival at home, with measures including patient level of depression, pain, physical functioning, self-efficacy with disease management, and medical service use.
Intervention / Treatment
OTHER: SWIFT home intervention
| Inclusion Criteria:
* Age 65 or more
* English-speaking
* Community dwelling (own home, vs. assisted living facility/skilled care)
* Living within specified service net
* Cognitively intact (as measured by a score of 5 or more on the SPMSQ)
* Meeting at lease one or more of the following:
* Age 75 or more
* Taking 5 or more prescription medications
* Had at least one inpatient admission or emergency department visit in previous 6 months
Exclusion Criteria:
* Age 64 or younger
* Non-English speaking
* Diagnosed with end-stage renal disease
* Hospice recipient
* Diagnosis of Alzheimer's disease or severe dementia
* Residing in assisted living or skilled care facility
* Homeless |
Study Objectives
The purpose of this study is to evaluate the difference in relapse rates and long term event free survival in patients with intermediate grade or immunoblastic non-Hodgkin's lymphoma (NHL) whose marrow is not obviously involved with NHL who are randomized to receive either an autologous bone marrow (ABMT) or peripheral stem cell transplant (PSCT). All patients with intermediate grade NHL with histologic negative bone marrow who would otherwise meet all eligibility criteria for high-dose therapy and ABMT are eligible for this study. Patients who are eligible will be randomized to either PSCT or ABMT at the time of enrollment into our transplant program.
Intervention / Treatment
PROCEDURE: PBSCT, PROCEDURE: Bone Marrow Transplant
| Inclusion Criteria:
* Age 16-65
* Intermediate grade non-Hodgkin's lymphoma (International Working Formulation - Follicular large cell, Diffuse Small Cleaved, Diffuse Mixed, Diffuse Large Cell, and Immunoblastic) with histologic negative bone marrow who would otherwise meet all eligibility criteria for high-dose therapy and ABMT. These criteria are in each specific high-dose therapy protocol (i.e. Karnofsky performance status > 70, adequate organ function, HIV and Hepatitis B negative, etc.). These patients would be enrolled in a high-dose protocol using carmustine, etoposide, cytarabine, and cytoxan (BEAC) with autologous hematopoietic rescue.
Exclusion Criteria:
* Patients with bone marrow histologically involved with tumor or with a bone marrow abnormality making bone marrow harvest not possible.
* Patients whose tumor is rapidly growing which may preclude the extra time involved with the PSC collection process.
* Patients who do not otherwise meet high-dose therapy and transplantation entry criteria. |
Study Objectives
Older people with cancer differ from younger patients due to the combined effects of aging, comorbidities and cancer treatments on their health. In acute myeloid leukemia (AML) and non-hodgkin lymphoma (NHL), chemotherapy, which is the main treatment, is associated with significant toxicity that negatively affects patients' physical capacities and quality of life, already declining with age and comorbidities. It therefore seems essential to develop and evaluate interventions that can prevent physical and psychosocial decline and its consequences in these populations. However, no studies have evaluated a physical activity (PA) program among these populations, although the absence of risk of implementing PA during intense therapeutic procedures has been confirmed.
OCAPI is an interdisciplinary, prospective, interventional, feasibility study. It is intended to include 20 AML and 20 NHL patients 65 years of age or older at the time of initiation of the first chemotherapy line, with an ECOG \<3, with no contraindications to PA and no history or coexistence of other primary cancer.
Expected results are to demonstrate that a program offering supervised sessions in a sterile room or at home and remote support can enable patients with AML or NHL to perform their daily PA in autonomy. All these results will generate preliminary data before implementing a larger national study.
Intervention / Treatment
OTHER: Individualized physical activity program
| Inclusion Criteria:
* Age 65 and over,
* With histologically confirmed non-Hodgkin's lymphoma (NHL) or acute myeloid leukemia (AML),
* Requiring a first line of chemotherapy treatment or Azacitidine - Vénétoclax combination,
* Followed-up in one of the investigating centers,
* Residing in one of the following departments: Ain, Ardèche, Drôme, Isère, Loire, Rhône, Savoie, Haute-Savoie,
* Having a ECOG < 3,
* With a life expectancy > 6 months,
* Whose ability to engage in physical activity has been certified by a medical certificate issued by the investigator physician,
* Available and willing to participate in the study for the duration of the intervention and follow-up,
* Able to understand, read and write French,
* Affiliated with a social security scheme,
* Having dated and signed an informed consent.
Exclusion Criteria:
* Personal history or co-existence of another primary cancer (except of in situ cancer regardless of the site and/or basal cell skin cancer and/or non-mammary cancer in complete remission for more than 5 years),
* Treated by immunotherapy alone,
* Participating in concurrent physical activity studies,
* Deprived of their liberty by court or administrative decision. |
Study Objectives
The aim of the study is to identify how often gastrointestinal problems interfere with quality of life as a result of treatment for cancer with chemotherapy. We also want to identify the causes for these symptoms and see if simple treatments used for other gastrointestinal conditions could make chemotherapy an easier experience. Chemotherapy for cancer can be hard work for the patient. Often it makes them feel tired. Not infrequently, it can cause a whole range of physical side effects. Probably the most common side effects are those affecting the stomach and bowels. Vomiting used to be a major problem with chemotherapy but research discovered a whole series of new treatments so that severe vomiting from chemotherapy is rarely a problem today. However, patients can develop a whole series of other symptoms during chemotherapy, for example, bloating, wind, diarrhoea, needing to rush to the lavatory and opening the bowels very frequently. The causes for these symptoms have hardly been studied even though they sometimes affect people quite badly. In our specialist gastrointestinal clinic at the Royal Marsden Hospital, over the last 12 years, we have pioneered new methods for dealing with symptoms which affect the bowel after radiotherapy. We would like to extend these methods to people having chemotherapy. We have identified several easily treatable causes for these symptoms after radiotherapy, which previously were often ignored. We believe that some of these causes also occur in people having chemotherapy and if we knew how often they do occur we could focus on improving treatment for affected people. We plan to find out how often 40 stomach and bowel symptoms occur during chemotherapy. In people who are troubled by any or some of these symptoms we will arrange simple series tests which could sort out why these symptoms occur and we will record how they respond to treatment.
Intervention / Treatment
| Inclusion Criteria:
* Patients aged 18 years or above able to give informed consent
* Patients referred to one of the five prescribing consultants described above
* Patients to be treated within the GI unit at the Royal Marsden Hospital (RMH Chelsea, Sutton or Kingston) with chemotherapy with or without other treatments.
Exclusion Criteria:
* Patients aged less than 18 years
* Patients unable to give informed consent
* Patients being treated privately
* Patients on studies with conflicting end-points |
Study Objectives
The aim of this project is to evaluate a person-centred informational intervention aimed at parents of children with cancer.
The following hypotheses will be tested: an informational intervention emanating from the parents' self-identified needs is associated to decreased illness-related parenting stress, decreased post-traumatic stress symptoms, increased received knowledge, decreased anxiety, decreased depression, increased satisfaction with information, and decreased number of health care contacts in parents.
Intervention / Treatment
BEHAVIORAL: Representational approach
| Inclusion Criteria:
Being a parent of a child that
* is diagnosed with a first time occurrence of a malignancy that is curatively treated and
* was diagnosed two months ago.
Further parents must be
* able to talk, read and write Swedish enough to be able to participate without an interpreter.
Exclusion Criteria:
* None specific. |
Study Objectives
The purpose of this study is to assess the relationship of assay sensitive patients versus assay resistant patients with progression free survival.
Intervention / Treatment
OTHER: ChemoFx
| Inclusion Criteria:
* Case has an original pathology report showing stage III, IIIa, IIIb, IIIc, IV, IVa, IVb, or recurrent endometrial cancer.
* Case includes a pathology or cytology report from initial diagnosis showing disease of one or more of the following histologic epithelial cell types: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, transitional cell carcinoma, clear cell carcinoma, or adenocarcinoma, not otherwise specified (N.O.S.).
* Case has been identified for pattern of response evaluation.
* Case must have a commercial ChemoFx drug response marker final report.
Exclusion Criteria:
* Cases of patients who were deceased prior to 1 cycle of chemotherapy. |
Study Objectives
The study is designed to evaluate how the composition of a participant's body, diagnosed with a brain tumor (glioblastoma multiforme) as determined by bioelectrical impedance analysis can predict the progression and outcomes of disease.
Intervention / Treatment
OTHER: Nutrition
| Inclusion Criteria:
* Subjects must be at least 19 years of age.
* Subjects must have a histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme).
* Women of childbearing potential must have a negative pregnancy test.
Exclusion Criteria:
* Subjects with implanted pacemakers or defibrillators.
* Subjects who are pregnant.
* Subjects with edema.
* Subjects with an amputated extremity. |
Study Objectives
Hypovitaminosis D is highly prevalent in people with lung cancer, and may have adverse clinical consequences. The long and variable pharmacokinetic half-life of vitamin D makes prompt vitamin D replacement problematic. This is an open, one-armed therapeutic intervention using a loading dose of vitamin D that will be predicted to increase plasma 25-hydroxyvitamin D concentrations of every patient well into the normal range (\> 100 nmol/L) within 2 or 3 weeks and monitored after 2 and 3 weeks of loading and maintenance dose. Preliminary data will also be obtained to identify potentially clinical important outcome benefits for future investigation. The outcomes are
1. plasma 25OHD concentration
2. Vitamin D binding protein and other plasma concentrations
3. Mood and symptom
Intervention / Treatment
DIETARY_SUPPLEMENT: vitamin D
| Inclusion Criteria:
* Any patient with advanced lung cancer whether or not receiving specific anti-cancer therapy
* Mentally competent (but need not be fluent in French or English if capable neutral translator available)
* Self report of reduced food intake and/or involuntary weight loss of any extent at time of enrollment: does not have to be documented
Exclusion Criteria:
* Current diagnosis of primary hyperparathyroidism
* Nephrocalcinosis
* Current or suspected active tuberculosis, histoplasmosis, sarcoidosis, or other granulomatous disease
* Current using a vitamin D supplement providing > 1000 IU/day
* Current prescribed calcitriol in any dose
* History of extensive sunlight exposure (> 30 min summer sunlight exposure per day for more than 5 days per week) in previous 3 months
* Expected to die within next 2 months
* Pregnancy |
Study Objectives
This early phase I trial studies giving propranolol hydrochloride with standard chemotherapy in treating patients with ovarian, primary peritoneal, or fallopian tube cancer. Biological therapies, such as propranolol hydrochloride, blocks certain chemicals that affect the heart and this may stimulate the immune system and allow the chemotherapy to kill more tumor cells.
Intervention / Treatment
DRUG: Chemotherapy, DRUG: Propranolol Hydrochloride, OTHER: Quality-of-Life Assessment, PROCEDURE: Therapeutic Conventional Surgery
| Inclusion Criteria:
* Suspected preoperative diagnosis of invasive epithelial ovarian cancer, primary peritoneal carcinoma, fallopian tube cancer based on imaging and cancer antigen (Ca) 125; histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell carcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified; patients with primarily carcinoma histology but mixed features can be included; the surgically confirmed histologic features must be compatible with primary Mullerian epithelial adenocarcinoma
* Stages II-IV of the above cancer
* Patients to be scheduled for a planned tumor debulking
* Intention for chemotherapy administration at MD Anderson Cancer Center
* Zubrod performance status 0-2
* Absolute neutrophil count (ANC) >= 1500/ml
* Platelets > 100,000/mL
* Creatinine clearance (CrCl) > 50 mL/min
* Bilirubin =< *5 x institutional upper limit normal
* Serum glutamic oxaloacetic transaminase (SGOT) =< *5 x institutional upper limit normal
* Alkaline phosphatase =< *5 x institutional upper limit normal
* Neuropathy (sensory and motor) =< grade 1 according to Common Toxicity Criteria for Adverse Events version 3 (CTCAE)
* Prothrombin time (PT) such that international normalized ratio (INR) is =< *5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for the management of venous thrombosis including pulmonary embolus)
* Partial thromboplastin time (PTT) < *2 times institutional upper limit of normal
* Pulse >= 60 beat per minute (bpm)
* Systolic blood pressure (SBP) > 110 mmHg; diastolic blood pressure (DBP) >= 60 mmHg
* Normotensive individuals not already on beta blockers (may be on other anti hypertensives): SBP =< 140, DBP =< 90
* Surgery or neoadjuvant chemotherapy must be scheduled at least 72 hours in advance in order for the patient to take at least 48 hours of prescribed propranolol and have stable vital signs confirmed
* An approved informed consent and authorization permitting release of personal health information must be signed by patient or guardian
* Patients of childbearing age must have a negative pregnancy test
* Patients who receive neoadjuvant chemotherapy for their ovarian, primary peritoneal, or fallopian tube cancer
Exclusion Criteria:
* Patients with non-epithelial ovarian tumors that do not require adjuvant chemotherapy, borderline epithelial ovarian tumor, or recurrent invasive epithelial ovarian, low grade ovarian cancer, primary peritoneal, or fallopian tube cancer treated with surgery only (such as patients with stage IA or IB); patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated new invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer are eligible, provided that they have not received chemotherapy for any tumor; no stromal cancers or germ cell cancers or low malignant potential; patients found post operatively to have ineligible histology will be removed from the study
* Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded; prior radiation therapy for localized cancer of the breast, head and neck, or skin is permitted provided that it was completed more than 3 years prior to registration, and the patient remains free of recurrent or metastatic disease
* Patients with a synchronous primary endometrial cancer, or a past history of primary endometrial cancer are excluded unless all of the following conditions are met: stage not greater than stage IA; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell, or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
* Patients who have received targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their primary peritoneal, ovarian, or fallopian tube cancer
* With the exception of non-melanoma skin cancer and other specific malignancies as noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last five years or whose previous cancer treatment contraindicates this protocol therapy are excluded
* Metastases to the ovaries from other organs except fallopian tube or primary peritoneal carcinoma
* Use of systemic glucocorticoids such as prednisone or Decadron in the last month
* Inability to accurately answer questions (e.g. dementia, brain metastases) or speak English or Spanish
* Cirrhosis of the liver
* Patients with a Zubrod performance status 3 or 4
* Comorbid conditions: Addison's disease, autoimmune hepatitis, hepatitis B, hepatitis C, acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV), lupus erythematosus, mixed connective tissue disease, rheumatoid arthritis
* Any patients already on beta-blockers or contraindicated to receive beta-blockers
* Hypersensitivity to propranolol, or beta-blockers
* Uncompensated congestive heart failure
* Cardiogenic shock
* Severe sinus bradycardia; heart block, second or third degree or sick sinus syndrome (if no artificial pacemaker present)
* Severe hyperactive airway disease (chronic obstructive pulmonary disease, asthma)
* Any patients planning to receive Avastin or any other anti-angiogenic drugs
* Patients with brittle diabetes mellitus (DM); brittle diabetes mellitus is a type of diabetes when a person's blood glucose (sugar) level often swings quickly from high to low and from low to high; also called "unstable diabetes" or "labile diabetes" |
Study Objectives
JTX-2011-101 is a Phase 1/2, open label, dose escalation and expansion clinical study of JTX-2011 alone and in combination with nivolumab, ipilimumab, or pembrolizumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.
Intervention / Treatment
DRUG: JTX-2011, DRUG: Nivolumab, DRUG: Ipilimumab, DRUG: Pembrolizumab
| Inclusion Criteria:
* Must be willing and able to participate and comply with all trial requirements and able to provide signed and dated informed consent prior to initiation of any trial procedures
* Evaluable or measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) v*1 criteria, and meet the requirements for the intended study cohort
* Male or Female ≥ 18 years of age
* Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-* Subjects with ECOG 2 may be considered for enrollment in Parts C, D, F, and H if approved by Medical Monitor
* Have a predicted life expectancy of ≥ 3 months
* Have laboratory values (obtained ≤ 28 days prior to first infusion day) in accordance with the study protocol
* If medical history of the following, case should be reviewed by the Medical Monitor: prior biliary tract disorders (as based on Hepatobiliary SOC high level terms of: obstructive bile duct disorders, hepatic vascular disorders, structural and other bile duct disorders) or portal hypertension and/or hepatic vascular disorders
* Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to administration of each dose of JTX-2011
* WOCBP and males with partners of child-bearing potential must agree to use adequate birth control throughout their participation and for 5 months following the last study treatment
Exclusion Criteria:
* Receiving concurrent anti-cancer treatment (excluding radiation therapy), either approved or investigational
* Have refused standard therapy
* Have received anti-cancer therapies listed below within the specified timeframe, or who have ongoing toxicity from prior therapy > Grade 1 according to the Common Terminology for Adverse Events (CTCAE). Exceptions to this are: > Grade 1 toxicities which in the opinion of the Investigator should not exclude the subject (e.g. alopecia, Grade 2 neuropathy, hypo- or hyperthyroidism or other endocrinopathies that are well-controlled with hormone replacement) and are approved by the Medical Monitor.
* Have received biologic therapy, including immunotherapy, < 28 days prior to C1D1;
* Have received CAR-T therapy;
* Have received chemotherapy < 21 days prior to C1D1, or < 42 days for mitomycin or nitrosoureas;
* Have received targeted small molecule therapy < 14 days prior to C1D1;
* Have undergone organ transplantation including allogeneic or autologous stem-cell transplantation, at any time;
* Have undergone a major surgery (excluding minor procedures, e.g. placement of vascular access, biopsy, etc.) < 6 months prior to the first day of study treatment, C1D1
* Have a history of intolerance, hypersensitivity, or treatment discontinuation due to severe immune adverse events on prior immunotherapy, or documented presence of neutralizing anti-drug antibody to nivolumab, ipilimumab, or pembrolizumab. Subjects who discontinued prior immunotherapies for immune-related adverse events that are well-controlled with appropriate treatment may be enrolled if approved by the Medical Monitor.
* Have a diagnosis of immunodeficiency, either primary or acquired, or treatment with systemic steroids or any other form of immunosuppressive therapy within 7 days prior to C1D* Exception: inhaled or topical steroids and adrenal replacement doses are permitted in the absence of active autoimmune disease as well as a one-time dose of immunosuppressive agents used prophylactically for contrast allergies
* Have any active disease requiring systemic immunosuppressive treatment
* Have known severe intolerance to or life-threatening hypersensitivity reactions to humanized monoclonal antibodies or intravenous immunoglobulin preparations; any history of anaphylaxis; prior history of human anti-human antibody response; known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent
* Are symptomatic or have uncontrolled brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation (brain metastases that are stable and asymptomatic, either treated or untreated, will be allowed)
* Have current second malignancy at other sites, which requires treatment, or in the judgement of the Investigator, may require treatment within the next year. Concurrent malignancies that do not require treatment and are clinically stable are allowed. A past history of other malignancies is allowed as long as the subject is not receiving specific treatment other than hormonal therapy, and, in the judgement of the Investigator, is unlikely to have a recurrence.
* Have active and clinically relevant bacterial, fungal, or viral infection, including known Hepatitis A, B, or C or human immunodeficiency virus (HIV) (testing not required)
* Have received live vaccines within past 30 days (inactivated vaccines are allowed; seasonal vaccines should be up to date prior to first infusion day)
* Women who are pregnant or breastfeeding
* Have experienced symptomatic cardiac disease that is unresponsive to surgical or medical management
* Have any medical or social condition that, in the opinion of the Investigator, might place a subject at increased risk, affect compliance, or confound safety or other clinical trial data interpretation |
Study Objectives
This is a multi-center, prospective, non-interventional study. The study will enroll about 1700 Chinese patients diagnosed as NSCLC and treated with osimertinib at least one dose.
The objective of this non-interventional study is to monitor the safety profile of osimertinib in Chinese NSCLC patients in real world clinical practice.
Intervention / Treatment
| Inclusion Criteria:
* Provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures
* Patients histologically or cytologically diagnosed as NSCLC
* Eligible for osimertinib treatment per the judgement of the treating physician in clinical practice
* Received at least one dose of osimertinib
Exclusion Criteria:
* Enrollment in other on-going studies, which prohibit any participation in this non-interventional study |
Study Objectives
Dupuytren's disease is a very common condition, affecting 4% of the general UK and US population. It causes the fingers to curl irreversibly into the palm and can be extremely disabling. The disease usually starts as a small firm lump (nodule) in the palm, and in about 40% of patients advances to form cords that pull the fingers into the palm. There is no approved treatment for the early stage of disease. Once patients have established deformities, the diseased tissue can removed by surgery or cut using less invasive techniques such as a needle or an enzyme. However, recovery following surgery usually takes several months and recurrence rates with the less invasive techniques are high.
The investigators have unravelled the cellular process that initiates and maintains the disease progress and identified tumour necrosis factor (TNF) as a new target for treatment. Based on these findings the investigators plan to test the effects of adalimumab, an anti-TNF drug which currently approved for use in patients with rheumatoid arthritis and other inflammatory conditions. The aim of the study is to find out whether treatment by injection with adalimumab directly into the diseased tissue will control the advance of early Dupuytren's disease better than a placebo injection with normal saline.
The investigators will first carry out a small trial in up to 40 patients with established disease to determine the best dose that reduces the activity of the cells responsible for the disorder (Dose Response study). In this part patients who will be having surgery to remove their diseased tissue will receive a single injection of adalimumab into the nodule in their hand about 2 weeks before surgery. The tissue that is then removed during surgery will be analysed in the investigator's laboratories to determine the effect of the drug on the tissue. Patients will be followed for 12 weeks after surgery.
In the second part of the study the investigators will assess whether the optimal dose of the drug prevents early disease advancing in 138 patients (Early Disease study). Patients who take part in the second part of the study will receive a total of 4 injections of adalimumab into the nodule in their hand at three monthly intervals. They will then be checked at 3 \& 9 months after the last injection. In additional to assessing the effect of the injections on the nodule and hand function, information will also be collected to assess the cost effectiveness of the treatment.
Intervention / Treatment
DRUG: Adalimumab, DRUG: Saline
| Inclusion Criteria:
* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* For Part 1: Diagnosed with DD affecting the fingers resulting in flexion deformities of ≥30° at the metacarpophalangeal joint and or the proximal interphalangeal joint with impaired hand function and awaiting surgery. Or for Part 2: Participants with early disease nodules who have shown or reported progression of the disease in the previous 6 months with flexion deformities of their fingers of ≤30° at the metacarpophalangeal and/or at the proximal interphalangeal joint, i.e. total flexion deformity of up to 60°.
* The DD nodule to be treated must be distinct and identifiable.
* Female participants of child bearing potential, and male participants whose partner is of child bearing potential, must be willing to ensure that they or their partner use effective contraception throughout the treatment period and for 5 months following the last research injection. Acceptable methods of contraception include: a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods), injectables, the combined oral contraceptive pill (at a stable dose for at least 3 months before entering the study), an intrauterine device, vasectomised partner, or true sexual abstinence (when this is in line with the preferred and usual lifestyle of the participant).
* Participant results from safety screening tests within normal ranges within 12 weeks of enrolment, with the exception that an earlier clear chest x-ray result may be used where this is in accordance with the time frames of local standard procedures for anti-TNF screening.
* Able (in the Investigators opinion) and willing to comply with all study requirements.
* Willing to allow his or her general practitioner to be notified of participation in the study.
* Sufficient language fluency to ensure informed consent is obtained and to complete the questionnaires pertaining to hand function.
Exclusion Criteria:
* For Part 1: Participant has previously had fasciectomy, dermofasciectomy, needle fasciotomy, collagenase injection, steroid injection or radiotherapy to treat Dupuytren's disease in the digit concerned. Or for Part 2: Participant has previously had fasciectomy, dermofasciectomy, needle fasciotomy, collagenase injection, steroid injection to the digit to be treated or radiotherapy to treat Dupuytren's disease in the hand concerned.
* Female participant who is pregnant, lactating or planning pregnancy during the course of the study and for 5 months following last injection.
* Male participant who is planning a pregnancy during the course of the study and for 5 months following last injection.
* Significant renal or hepatic impairment.
* For Part 1: Scheduled elective surgery or other procedures requiring general anaesthesia during the study other than the scheduled Dupuytren's surgery. Or for Part 2: Scheduled elective surgery or other procedures requiring general anaesthesia during the study
* Participant who has ever been diagnosed with cancer, is terminally ill or is inappropriate for placebo medication
* Systemic inflammatory disorder such as rheumatoid arthritis (RA) or inflammatory bowel disease.
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
* Participated in another research study involving an investigational medicinal product in the past 12 weeks.
* Known allergy to any anti-TNF agent.
* Have HIV or hepatitis B or C.
* Known to have an infection or history of repeated infections.
* History of Tuberculosis (TB).
* Have Multiple Sclerosis (MS) or other demyelinating disease.
* History of local injection site reactions.
* Needle phobia.
* Have moderate or severe heart failure.
* Part 1: Being treated with coumarin anticoagulants, such as warfarin.
* Have known lung fibrosis (thickening of lung tissue).
* Being treated with concomitant biologic DMARDS.
* Have received a live vaccine within the previous 4 weeks. Participants may receive concurrent vaccinations but must avoid the use of live vaccines for 12 weeks after their last injection.
* Part1: Have received parenteral steroid within the previous 6 weeks.
* Part 2: Participants at risk of Hepatitis B infection. |
Study Objectives
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving antihormone therapy together with ipilimumab may kill more tumor cells.
PURPOSE: This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer.
Intervention / Treatment
DRUG: Bicalutamide, DRUG: Flutamide, DRUG: Goserelin Acetate, DRUG: Ipilimumab, DRUG: Leuprolide Acetate, OTHER: Pharmacological Study
| Inclusion Criteria:
* NOTE: All values must be obtained =< 14 prior to study entry
* Histologically confirmed adenocarcinoma of the prostate staged within 180 days of study enrollment, >cT2cN0/M0 stage with or without metastatic disease, with the exclusion of central nervous system (CNS) metastases; includes post radical prostatectomy patients with a rising PSA
* An initial PSA >= *0 ng/mL (Hybritech Assay)
* For those patients who have received hormone therapy =< 21 days, a documented PSA of >= *0 prior to initiation of hormone therapy is acceptable.
* For patients who are post radical prostatectomy, a rising PSA is acceptable.
* Adequate organ function defined as: WBC >= 3,000/uL; platelets >= 75,000/uL; total bilirubin =< *5 mg/dL; transaminases =< *5 x upper limit of normal (ULN); serum creatine =< *0 mg/dL or calculated creatinine clearance >= 60 mL/min
* ECOG performance status of 0-2
* Able to understand and sign informed consent
Exclusion Criteria:
* Underlying other serious medical condition which, in the opinion of the investigator precludes study participation; this includes immune-suppressive disease such as AIDS or autoimmune disorders such as multiple sclerosis, lupus, or myasthenia gravis
* Patients not recovered from major infections and/or surgical procedures
* Prior hormonal therapy > 21 days prior to enrollment, including estrogens, LH/RH agonists, or antiandrogens
* Recent (=< 3 months of informed consent) usage of immune-suppressive medication including steroids, Immuran, Cyclosporin; topical or inhalational steroid use is permissible
* Prior systemic chemotherapy
* Prior radiation therapy to the prostate
* Prior malignancy, unless the patient has been cancer-free for five years or more
* Uncontrolled underlying medical or psychiatric illness, or serious active infections
* Patient unwilling to complete all required follow-up visits
* History of motor neuropathy considered of the autoimmune origin (e.g. Guillian-Barre Syndrome)
* Concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer
* For patients who elect to undergo the baseline transrectal needle biopsy of the prostate, current usage of systemic anticoagulation therapy, i.e. heparin or Coumadin or inability to discontinue aspirin, aspirin-containing products or ibuprofen for seven days prior to the prostate biopsies required for this study
* No other investigational drugs will be allowed during the study
* Other chemotherapy, radiation therapy, immunotherapy, hormonal therapy, or biologic therapy may not be used while the patient is on study |
Study Objectives
In the past decade, colorectal cancer management improved considerably with total mesorectal excision as well as the multidisciplinary management relying on neoadjuvant radiochemotherapy. This forward leap is currently responsible for an increase in the survivorship of colorectal cancer patients to more than 50% at 5 years. Additively the surgical approach is now more inclined towards sphincter preserving procedures, which allows the conservation of body image but can have negative bowel function repercussions consisting of urgency and incontinence ; all these terms encompassed in the low anterior resection syndrome.
In the light of these findings many studies developed assessment tools in order to objectively measure this functional alteration among which are the low anterior resection syndrome questionnaire (LARS) and the WEXNER score. These tools designed to assess bowel function after sphincter-preserving surgery are now translated and validated into various languages and used in different countries.
The LARS score relies on the frequency of the symptoms and allows the categorization of patients into 3 groups: no LARS (0-20 points), minor LARS (21-29 points), and major LARS (30-42 points). It assesses the frequency of emptying, incontinence ( liquid, gas ), and other symptoms such as urgency and incomplete voiding. On the other hand, the WEXNER score relies on the examination of the frequency of three types of fecal incontinence (solid, liquid, and gas) and their consequences (pad wearing and lifestyle alteration) with frequency options ranging from never (score 0) through to always (meaning at least once per day; score 4). The score ranges from 0 (perfect continence) to 20 (complete incontinence).
The aim of our study is to adapt and validate the LARS and WEXNER score to the moroccan arabic dialect.
Intervention / Treatment
DIAGNOSTIC_TEST: MA_LARS
| Inclusion Criteria:
* Patients aged older than 18 years.
* Neoplasm of the rectum.
* Rectal cancer patients undergoing curative sphincter-preserving surgery with (partial or total) mesorectal excision.
* Surgery performed between January 2012 to March 2019, with reversal of the defunctioning stoma before March 2019;
* Bowel continuity restoration for at least 6 months.
* Consent to participate in the study.
Exclusion Criteria:
* Palliative surgery.
* The presence of a definitive iliac or perineal stoma.
* Diseases of bowel dysfunction (Crohn's disease)
* Cognitive and/or language issues. |
Study Objectives
The purpose of this clinical trial is to understand if women undergoing surgery for a suspected gynecologic malignancy are interested in participating in a Mindful Movement and Breathing program and what the effects of this program are on women and the surgery-related symptoms they experience. Mindful Movement and Breathing programs may be effective for easing distress, post-surgical pain, and other symptoms of surgical procedures.
Intervention / Treatment
OTHER: Mindful Movement and Breathing program, OTHER: Questionnaire administration, PROCEDURE: The Observer Mobility Scale, PROCEDURE: Volumetric Incentive Spirometry
| Inclusion Criteria:
* Signed protocol specific informed consent
* 18 years of age or older
* Scheduled for a major abdominal gynecological surgery to remove a mass that is suspected to be malignant
Exclusion Criteria:
* Unable to read or understand English
* Cognitively impaired and/or cannot complete interviews as judged by the referring physician, nurse, or study staff |
Study Objectives
Staying confined in the bed is frequent at the end of life. The cancer patients can also experiment this situation, and consequences are painful, with pain increasing with the time. This pain are related to the joints stiffing , muscles mass decreasing, and tendons retractions . The non pharmacological approach associated with the conventional treatments can be interesting to assess in this frails patients.
Intervention / Treatment
OTHER: Osteopathic treatment
| Inclusion Criteria:
* Man or woman
* Aged 18 years or older
* Having signed informed consent to participate in the study
* Patient affiliated to a social security scheme
* Patient with pain affecting the musculoskeletal system following prolonged bed rest
* Capable to understand French
* Capable of completing self-assessment scales
Exclusion Criteria:
* Patients with bone metastases at risk for the use of osteopathy
* Patients under legal protection measures
* Patients with cognitive impairment preventing self-evaluation
* Patient who is considered too fragile or with a clinical condition too unstable by the doctor refer to be included in the study
* Patients in the pre-agonic or agonic phase |
Study Objectives
This is a Phase 1 open-label study evaluating the safety of navitoclax (ABT-263) when combined with a standard regimen of gemcitabine in approximately 50 subjects with solid tumors and measurable disease.
Intervention / Treatment
DRUG: ABT-263, DRUG: gemcitabine
| Inclusion Criteria
* Age greater then or equal to 18 years.
* For the 21 and 28-day dose escalation cohorts and the 21-day safety expansion cohort subjects must have histologically and/or cytologically documented cancer for which gemcitabine has been determined to be an appropriate therapy, per the Investigator.
* For the 28-day safety expansion cohort, subjects must have histologically and/or cytologically documented ductal adenocarcinoma or undifferentiated carcinoma of the pancreas for which gemcitabine has been determined to be an appropriate first-line therapy, per the investigator.
Note: If the 28-day dose escalation schedule is deemed intolerable and further dose de-escalation is not explored, the expanded safety cohort will evaluate navitoclax (ABT-263) in combination with gemcitabine in an additional 12 to 15 subjects with histologically ductal adenocarcinoma or undifferentiated carcinoma of the pancreas for which gemcitabine has been determined to be an appropriate first-line therapy with the RPTD and schedule from the 21-day portion of the study.
* Measurable disease by CT or MRI as defined RECIST.
* Subjects with brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function and no evidence of CNS disease progression as determined by CT or MRI within 28 days prior to the 1st dose of study drug.
* ECOG less then or equal to *
* Must have adequate bone marrow, renal and hepatic function per local laboratory reference range as follows:
* Bone marrow:Absolute Neutrophil Count greater then or equal to1500/μL; platelets greater then or equal to 150,000/mm\^3; hemoglobin greater then or equal to *0 g/dL;
* Renal function: Serum creatinine less then or equal to *0 mg/dL or calculated creatinine clearance greater then or equal to 50 mL/min;
* Hepatic function and enzymes: AST , ALP and ALT less then or equal to *0 × the upper limit of normal (ULN), bilirubin less then or equal to *5 × ULN.
* Subjects with liver metastasis may have AST, ALP, and ALT less then or equal to *0 X ULN.
* Subjects with bone metastasis may have ALP less then or equal to *0 × ULN; Coagulation: aPTT and PT not to exceed *2 × ULN.
* Female subjects must be surgically sterile, postmenopausal (for at least 1 year), or have negative results for a pregnancy test performed as follows: at Screening via serum sample obtained within 14 days prior to initial study drug administration and prior to dosing via urine sample obtained on Cycle 1 Day 1, if it has been greater then 7 days since obtaining the serum pregnancy test results.
* Female subjects not surgically sterile or postmenopausal (for at least 1 year) and non-vasectomized male subjects must practice at least 1 of the following methods of birth control:
* total abstinence from sexual intercourse (minimum 1 complete menstrual cycle);
* vasectomized partner;
* hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration;
* Double-barrier method (including condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream).
Exclusion Criteria
* Underlying, predisposing condition of bleeding or currently exhibits signs of bleeding.
* Recent history of thrombocytopenia associated with bleeding w/i 1 year prior to 1st dose of study drug.
* Currently receiving or requires anticoagulation therapy or any drugs or herbal supplements that affect platelet function, w/the exception of low-dose anticoagulation medications that are used to maintain the patency of a central iv catheter.
* Active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis.
* Active immune thrombocytopenic purpura, autoimmune hemolytic anemia or a history of being refractory to platelet transfusions (w/i 1 year prior to the 1st dose of study drug).
* Received radio-immunotherapy w/i 6 months prior to 1st dose of study drug.
* Received an antibody therapy or other biologics (with the exception of colony stimulating factors \[G-CSF,GM-CSF\] or erythropoietin) w/i 28 days prior to 1st dose of study drug.
* Received anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal therapy (with the exception of hormones for hypothyroidism, ERT, anti-estrogen analogs, LHRH, GnRH agonists required to suppress serum testosterone levels if on a stable dose for at least 21 days prior to the 1st dose of study drug), or any investigational therapy w/i 14 days prior to the 1st dose of study drug, or has not recovered to less than a grade 2 clinically significant adverse effect(s)/ toxicity(s) of the previous therapy.
* Received steroid therapy for anti-neoplastic intent w/i 7 days prior to the 1st dose of study drug. (Inhaled steroids for asthma, topical steroids, replacement/stress corticosteroids, or corticosteroids taken as premedication for this study will not be considered exclusionary).
* Received aspirin w/i 7 days prior to 1st dose of study drug.
* History of hypersensitivity to gemcitabine.Positive for HIV.
* Significant history of cardiac, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease.
* Exhibits evidence of other clinically significant uncontrolled condition; active systemic fungal infection;diagnosis of fever \& neutropenia w/i 1 week prior to study drug administration.
* The subject has undergone prior procedures or has active gastrointestinal disease that would result in the inability to adequately absorb an oral medication (e.g., uncontrolled nausea, vomiting, inflammatory disease, bowel obstruction, or a major bowel resection). |
Study Objectives
The trial is a Phase II, open label, Simon's two stage study design to evaluate the efficacy and safety of Tenalisib in patients with CLL who have relapsed or are refractory after at least one prior therapy.
Intervention / Treatment
DRUG: Tenalisib
| Inclusion Criteria:
* Patients with diagnosis of B-cell CLL
* Disease status defined as refractory to or relapsed after at least one prior therapy.
* Presence of measurable lymphadenopathy presence of > 1 nodal lesion
* ECOG performance status ≤ *
* Adequate bone marrow, liver, and renal function
Exclusion Criteria:
* Richter's (large cell) transformation, or PLL transformation.
* Cancer therapy/ any cancer investigational drug within 3 weeks (21 days) or 5 half-lives (whichever is shorter).
* Prior exposure to drug that inhibits PI3K
* Patient with ASCT/Allo-SCT receiving treatment for active GVHD.
* Ongoing severe systemic bacterial, fungal or viral infection.
* Central nervous system (CNS) involvement of leukemia or lymphoma.
* Ongoing immunosuppressive therapy including systemic corticosteroids.
* Known history of severe liver injury as judge by investigator.
* Any severe and/or uncontrolled medical conditions or other conditions that could affect patient participation
* Women who are pregnant or lactating.
* Known seropositive requiring anti-viral therapy for i. human immunodeficiency virus (HIV) infection. ii. hepatitis B virus (HBV) infection iii. hepatitis c virus (HCV) infection iv. active CMV infection
- |
Study Objectives
Despite certain notable progress, treatment of patients with Chronic Lymphatic Leukemia (CLL) is still disappointing. Although thanks to the use of treatment of (immune) chemotherapy, mainly based on fludarabine, rituximab and alemtuzumab, the rate of complete response (CR) has increased from minus 10% observed when clorambucil was the core of the therapy to a 60-70%, with time all patients relapse and most of them die at the end due to the disease or to involvements related to the treatment. Progress when understanding the CLL biology have cleared a series of aspects: 1) there is a significant proportion of CLL cells actively copying themselves, contrary to the opinion that most of CLL cells are in G0 phase of the cell cycle; 2) Immune regulatory mechanism basically measured by T cells and NK cells have an important role in the continuous accumulation of CLL cells in the body; 3) Cells of the stroma are essential to maintain survival of CLL cells through a series of cytokines or chemokines. Under the light of this evidence, it is worth studying new treatment modes directed not only to CLL cells but also to the microenvironment and immune functions.
Lenalidomide is being investigated as treatment for several oncologic indications including myelodysplastic syndromes, multiple myeloma and non-Hodgkin lymphoma. Within the scope of CLL, it has been proved that lenalidomide is active in patients with relapsing / treatment resistant CLL patients. Forty five patients with relapsing CLL, 51% resistant to fludarabine, where included in a phase II study and were treated orally with 25 mg of lenalidomide on days 1 to 21 of a cycle of 28 days. The total response rate was of 47% with up to a 9% of complete responses.
The combination of lenalidomide with dexamethasone is being investigated in multiple myeloma and has revealed as a highly efficient treatment in relapsing/ treatment resistant patients as well as in those newly diagnosed. Bearing in mind that both drugs, lenalidomide and dexamethasone, are clinically active in CLL the investigators have designed a study with this combination in relapsing or treatment resistant patients following treatments containing fludarabine which do not meet the requirements for an intensive rescue treatment.
Given initial doses of 10 and 25 mg of lenalidomide daily may be associated with tumor lysis cases, it is proposed a low initial dose of lenalidomide in the first cycle 2.5mg., with further increases to prevent the occurrence of tumor lysis syndrome
Intervention / Treatment
DRUG: Lenalidomide, DRUG: Dexamethasone
| Inclusion Criteria:
The patients will have to meet the following inclusion criteria in order to be included in the study:
* To understand and voluntarily sign an informed consent form.
* To be ≥ 18 years old upon the signature of the informed consent form.
* To be able to fulfill the visits program of the study and other protocol requirements.
* To have a CLL documented diagnose (NCI/WG criteria) relapsing or resistant to at least one prior treatment and not to meet the requirements for an intensive rescue therapy. Prior treatment(s) will have to include fludarabine.
* All prior anti-cancer therapies, including radiation, hormonal therapy and surgery, will have to be interrupted at leas 4 weeks before the treatment in this study.
* Functional state 0-2 (ECOG).
* Women with childbearing potential (FCBP) will have to:
understand the teratogenic risk of the study drug. accept the simultaneous use of two reliable contraception methods or to practice the abstinence of heterosexual relations during the following periods of time related to this study: 1) during at least 4 weeks before starting the drug of the study; 2) while participating in the study; y 3) during at least 4 weeks following the interruption of the study. The two reliable contraceptive methods will have to include one highly effective (this is, intrauterine device (IUD), hormonal (pills injections or implants), tubal ligation, vasectomy of the partner) and an barrier effective additional method (this is, latex preservative, diaphragm, cervical cap). Women with a childbearing potential will have to visit a specialist in contraceptive methods if necessary.
Before starting the drug under study: * Women with childbearing potential will have to undergo two negative pregnancy tests (sensibility of at least 25 mUI/ml) before starting the drug under study. The first test will take place at the visit date or within a period of 3 days before starting the drug under study and the second.The patient will not receive the drug until the investigator has verified that the results of the tests are negative.
Men:
* They will have to accept the use of latex preservatives during sexual relations with women with childbearing potential while they participate in the study and during at least one week following the interruption of the study, if it is women with childbearing potential (FCBP) and no use contraception.
* They will have to accept to refrain from donating blood or semen during their participation in the study and during at least 28 days following the interruption of the study.
* In the event of pregnancy or positive pregnancy test in a participant in the study, or the partner of a male participant in the study, during his participation, the drug under study will be immediately interrupted.
* Capable of receiving Acetyl Salicylic Acid (100 or 300 mg) on a daily basis as prophylactic anticoagulation. (Patients who do not tolerate ASA may use acenocumarol or low molecular weight heparin).
Exclusion Criteria:
Patients will not have to fulfill any of the following exclusion criteria to be included in the study.
* Any serious medical disorder, laboratory abnormality or psychiatric disease hindering the signature of the informed consent by the patient.
* Pregnant women or in lactation period.
* Any disorder, including the presence of laboratory abnormalities, which puts the patient at unacceptable risk if he/she participates in the study or hindered the capacity to understand the information of the study.
* Use of any other experimental drug or therapy in the period of 28 days from the base visit.
* Known hyper-sensibility to thalidomide.
* Development of erythema nodosum if it is characterized by a descamative eruption while taken thalidomide or similar drugs.
* Any prior use of lenalidomide.
* A concurrent use of other agents or anticancer treatments.
* HIV-positive or infectious hepatitis type A, B or C.
* Candidates eligible for intensive rescue therapies (ex. R-CHOP plus alemtuzumab, allogenic transplant)
* Richter transformation (active) or CNS participation (active)
* Any of the following laboratory abnormalities:
Neutrophil absolute count < *5 x 109/L Platelet count < 25 x 109/L Calculated Creatinine Clearance <50 mL/min Total serum bilirubin > higher normal limit (HNL) AST and ALT >3 x higher normal limit (HNL) Autoimmune non controlled hemolytic anemia or thrombocytopenia.
* History of another neoplastic disease during ≥ 5 years unless base cells or epidermoid carcinoma in situ of cervix or breast recently treated. |
Study Objectives
An open label, multicenter, phase Ia/Ib study to evaluate the safety, tolerability, and initial efficacy of IBI318 in the treatment of patients with advanced malignancies.
Intervention / Treatment
BIOLOGICAL: IBI318, BIOLOGICAL: IBI318, BIOLOGICAL: IBI318, BIOLOGICAL: IBI318, BIOLOGICAL: IBI318, BIOLOGICAL: IBI318, BIOLOGICAL: IBI318, BIOLOGICAL: IBI318, BIOLOGICAL: IBI318, BIOLOGICAL: IBI318, BIOLOGICAL: IBI318
| Inclusion Criteria:
* Sign the informed consent form
* Men or women 18 years or older
* Expected survival time ≥ 12 weeks
* Tumor assessment according to RECIST v*1, at least one measurable lesion
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Have adequate organ and bone marrow function
* Male participants and female participants must agree to use contraception during the treatment period and within 180 days after the treatment period
* Female subjects must not be pregnant or breastfeeding. If premenopausal, negative urine or serum pregnancy tests are required
* Ia: Subjects with locally advanced, recurrent or metastatic histologically or cytologically confirmed solid tumors or hematologic tumors and are refractory or intolerant to existing standard treatments
* Ib: Metastatic non-small cell lung cancer, advanced liver cancer, advanced esophageal squamous cell cancer, advanced gastric cancer, or other tumors that have been proved by histology or cytology with initial therapeutic effect in Phase Ia
Exclusion Criteria:
* Previous exposure to immunotherapy including but not limited to, anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anti-tumor vaccine
* Participation in another interventional clinical study, an observational (non-interventional) clinical study, or a follow-up phase of an interventional study
* Receive last anti-tumor treatment within 4 weeks prior to the first dose of study drug
* Use of immunosuppressive drugs within 4 weeks prior to the first dose of study drug
* Require long-term steroid therapy or any other form of immunosuppressive therapy not including inhaled steroids
* Toxicity (excluding hair loss or fatigue) caused by previous antitumor therapy that did not recover to NCI CTCAE v *0 level 0-1 within 4 weeks prior to the first dose of study drug
* Received major surgery or has unhealed wounds, ulcers, or fractures within 4 weeks prior to the first dose of study drug
* Expect to receive other anti-tumor treatments during study (allowing palliative radiotherapy)
* History of infectious pneumonitis that required steroids or has current pneumonitis
* Known active untreated CNS metastases and/or spinal cord compression and/or cancerous meningitis, or with a history of soft meningeal cancer
* Active autoimmune disease that has required systemic treatment in past 2 years
* Known active Hepatitis B or Hepatitis C virus
* Uncontrolled concomitant diseases or neurological, psychiatric/social conditions that could affect study compliance, significantly increase the risk of adverse events, or affect the participant's ability to provide written informed consent
* Known history of human immunodeficiency virus (HIV) infection
* Known history of active tuberculosis (TB) or active syphilis
* History of allogeneic organ transplantation or hematopoietic stem cell transplantation
* Accompanied by uncontrolled third interstitial fluids requiring repeated drainage, such as pleural effusion, ascites, pericardial effusion, etc.
* Known severe allergic reactions to other monoclonal antibodies or are allergic to any IBI318 formulation component
* Female subjects who are pregnant or lactating |
Study Objectives
The purpose of the study is to examine the efficacy of educational materials to promote hepatitis C virus (HCV) screening and colorectal cancer (CRC) screening uptake among adults born between 1945-1965.
Intervention / Treatment
BEHAVIORAL: CARES-HCV
| Inclusion Criteria:
* Born between 1945 and 1965 and up to age 75
* No personal history of colorectal cancer (CRC) or current presumptive colorectal cancer symptoms (e.g., unresolved rectal bleeding or abdominal pain/bloating)
* No personal history of hepatitis C virus (HCV) or liver cancer
* Able to read, write, speak, and understand English or Spanish
* Not currently enrolled in another CRC screening or a HCV screening study
* At average risk for CRC (that is, no hereditary CRC syndromes such as lower gastrointestinal (GI) bleeding, persistent diarrhea, bloating, or lower GI pain, no strong family history of CRC)
* Not currently up-to date with CRC screenings
* Not having previously completed HCV screening
* Able and willing to complete a phone interview
* Able to provide informed consent |
Study Objectives
The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.
Intervention / Treatment
DRUG: Ga-68 labeled PSMA-11 PET
| Inclusion Criteria:
* Histopathological proven prostate adenocarcinoma.
* Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
* Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation
* PSA greater than *2 ng/mL measured more than 6 weeks after RP and,
* Confirmatory persistent PSA greater than *2 ng/mL
* Post-radiation therapy -ASTRO-Phoenix consensus definition
* Nadir + greater than or equal to 2 ng/mL rise in PSA
* Karnofsky performance status of greater than 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent).
* Age > *
* Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria:
* Investigational therapy for prostate cancer.
* Unable to lie flat, still or tolerate a PET scan.
* Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
* Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device). |
Study Objectives
This is a multicenter, single-arm, phase II study to evaluate the efficacy and safety of CS1001 monotherapy for Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma (ENKTL)
Intervention / Treatment
BIOLOGICAL: CS1001
| Inclusion Criteria:
* Subject must have a histologically confirmed NKTL at study site.
* Subject must have relapsed or refractory NKTL after prior asparaginase-based chemotherapy or chemo radiotherapy.
* ECOG PS of 0 or *
* Subject must have at least one evaluable or measurable lesion per Lugano 2014 classification.
* Subject must have adequate organ function and bone marrow function without severe hematopoietic disorder, or heart, lung, liver or kidney dysfunction or immune deficiency.
* Subject must provide stained tumor tissue sections and corresponding pathological report or unstained tumor tissue sections (or tissue block) for central pathology review.
* Subject with prior anti-cancer treatment can only be enrolled when the toxicity of prior anti-cancer treatment has recovered to baseline or ≤ Grade 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v**
Exclusion Criteria:
* Invasive natural killer leukemia.
* Concomitant with hemophagocytic syndrome.
* Primary site in central nervous system (CNS) or CNS involvement.
* Subjects currently participating in other clinical studies or use of any investigational drug within 4 weeks prior to the first dose of CS*
* Subjects who received systemic corticosteroid or any other immunosuppressive therapy within 14 days prior to the first dose of CS*
* Subjects who had prior chemotherapy, immune therapy, biological therapy as systemic treatment for cancer, within 28 days prior to the first dose of CS*
* Receipt of traditional medicinal herbal preparations with anti-tumor indications with 7 days prior to the first dose of CS*
* Known history of human immunodeficiency virus (HIV) infection and/or acquired immune deficiency syndrome.
* Subjects with active hepatitis B or C infection.
* Subjects with active tuberculosis infection.
* Subjects who received prior therapy with anti-PD-1, anti-PD-L1 or anti-CTLA-4 monoclonal antibody.
* Female subjects who are pregnant or breast-feeding.
For more information regarding trial participation, please contact at [email protected] |
Study Objectives
In this pilot study participants will undergo routine magnetic resonance imaging and routine neurosurgical care. By prospectively collecting data from both MRI and patient records we want to investigate biomarkers derived from tractography and diffusion tensor imaging to predict rehabilitation potential.
Intervention / Treatment
OTHER: routine MRI
| Inclusion Criteria:
* intracranial lesion
* elective neurosurgical procedure
Exclusion Criteria:
* MRI not applicable
* cerebral ischemia during study period
* pregnancy during study period
* encephalitis during study period
* spontaneous intracerebral hemorrhage during study period |
Study Objectives
The primary aim of this study is to evaluate the impact of introducing a new enteral tube feed on health and feeding related quality of life. Secondary aims are to assess ease of use, liking, compliance, gastrointestinal tolerance, nutrient intake, anthropometric changes and safety.
Intervention / Treatment
OTHER: Bolus Pouch Feed
| Inclusion Criteria:
* ≥16 years of age
* Using or requiring an enteral tube feed as part of nutritional management plan
* Using or about to use bolus tube feeding methods at least once daily
* Expected to receive at least 400 kcal/day from the intervention feed
* Written or electronic informed consent from patient, or verbally given consent countersigned by a witness for those physically unable to sign.
Exclusion Criteria:
* Parenteral nutrition contributing more than 70% of total energy requirements
* Patients with major hepatic dysfunction (i.e., decompensated liver disease)
* Patients with major renal dysfunction \[i.e., requiring filtration or stage 4/5 chronic kidney disease (CKD)\]
* Patients receiving inpatient care
* Participation in other clinical intervention studies within 2 weeks of this study
* Adults lacking mental capacity to consent
* Allergy to any study product ingredients
* Investigator concern regarding ability or willingness of patient to comply with the study requirements. |
Study Objectives
The study aims to evaluate the stability and efficacy after administration of \[177Lu\]Ludotadipep in patients with metastatic castration resistant prostate cancer (mCRPC), with dose-escalation applied to determine the appropriate dose.
Intervention / Treatment
DRUG: [177Lu]Ludotadipep
| Inclusion Criteria:
* Among prostate cancer patients with blood testosterone ≤50ng/dL, mCRPC patients showing radiological progression after standard taxene-based anticancer treatment and 2nd generation hormone agent (abiraterone, enzalutamed, or both)) treatment or patients who are not eligible for such standard medical treatment at the discretion of an investigator or patients who refuse such standard treatment
* Patients who are positive on the \[18F\]PSMA PET/CT imaging
* Subjects who were fully informed by an investigator of the study objectives, details, and characteristics of the study drug prior to study enrollment, and had an informed consent form signed by the subject or caretaker or legally acceptable representative
* Male patients aged 20 years or older
* Subjects who are sexually active and have a female partner of childbearing potential should meet the followings
* Subjects should consent to practice contraception by continuously using a male condom from screening, throughout the study, and for at least 6 months after the last dose of the study drug
* Subjects should never donate sperms from screening, throughout the study, and for at least 6 months after the last dose of the study drug
* Subjects with a partner who is a woman of childbearing potential (including a pregnant or breastfeeding mother) should consent to maintain sexual abstinence or practice double contraception throughout the study \* Double contraception: Corresponding to 2 or more of the followings - use of a condom, use of a non-hormonal intrauterine device, use of a diaphragm, use of a cervical cap, a sexual partner who has been vasectomized at least 3 months (as of the first screening visit) or a sexual partner medically diagnosed to be sterile
* ECOG _ Performance score ≤2
* Life expectancy ≥6 months
Exclusion Criteria:
* Subjects determined by an investigator to have a serious medical condition making study conduct difficult
* Subjects corresponding to the following conditions 1) Glomerular filtration rate ≤40 ml/min, 2) hemoglobin level ≤*0 g/dL, 3) white cell count ≤*0 × 109/L, 4) platelet count ≤100 × 109/L, 5) total bilirubin level ≥*5 x upper normal limit, 6) serum albumin level ≤*0 g/dL, 7) active ischemic heart disease or heart failure (New York Heart Association Classification III-IV), 8) uncontrolled diabetes/hypertension, 9) hyperkalemia >*0 mmol/L
* Vulnerable subjects (the investigator involved in the study or his/her family, research staff or students of the investigator involved in the study)
* Patients with a persistent malignancy other than the prostate cancer
* Patients who participated in a therapeutic clinical trial within the past 30 days and administered an investigational product other than standard treatment
* Patients are excluded if treatment other than the treatment provided in this study is determined more appropriate as determined by the investigator based on the patient and disease characteristics |
Study Objectives
The goal of this clinical trial is to test passive music therapy in patients receiving induction chemotherapy for an acute myeloblastic leukemia or undergoing an hematopoietic stem cell transplantation. The main questions it aims to answer are:
- Can music therapy control physical and psychological symptoms and improve the mood and quality of life of these patients?
Participants will be randomly assigned to the control and experimental group. Patients included in both groups will complete weekly mood and quality of life questionnaires. Those included in the experimental group will also complete daily symptom burden questionnaires before and after listening to a music therapy session.
Researchers will confirm if the experimental group improves their symptoms after the music therapy session and will compare both groups to see if there are differences in mood and quality of life.
Intervention / Treatment
BEHAVIORAL: Passive music therapy
| Inclusion Criteria:
* ≥ 18 years old.
* Patients receiving induction chemotherapy for a newly diagnosed acute myeloblastic leukemia (except for acute promyelocytic leukemia).
* Patients undergoing autologous or allogeneic stem cell transplantation.
* Being able to understand and read Spanish properly.
* Basic computer skills.
Exclusion Criteria:
* Moderate-severe hearing impairment (unilateral or bilateral).
* Past history of psychiatric disorders.
* Performance status: ECOG ≥ * |
Study Objectives
The goal of this clinical research study is to find the highest tolerable dose of nivolumab that can be give in combination with idarubicin and cytarabine in patients with MDS and AML. The safety and effectiveness of this drug combination will also be studied.
This is an investigational study. Nivolumab is not FDA-approved or commercially available. Idarubicin is FDA-approved and commercially available for the treatment of patients with AML. Cytarabine is FDA approved and commercially available for treatment of patient with AML. The use of these drugs in combination is investigational. The study doctor can explain how the drugs are designed to work.
Up to 75 patients will take part in this study. All will be enrolled at MD Anderson.
Intervention / Treatment
DRUG: Nivolumab, DRUG: Idarubicin, DRUG: Cytarabine, DRUG: Solu-medrol, DRUG: Dexamethasone
| Inclusion Criteria:
* Diagnosis of 1) AML (WHO classification definition of >/= 20% blasts), or 2) high risk MDS (defined as the presence of 10% blasts).
* Patients aged 18 to 60 years are eligible. Patients older than 60 who are deemed fit to receive intensive chemotherapy by the treating physician are eligible after discussion with the PI.
* In the Phase I portion, patients with relapsed or refractory AML/MDS are also eligible, as per the treating physician's discretion.
* For the Phase II portion of the study, patients must be chemo-naive, i.e. not have received any prior chemotherapy (except hydrea or one dose of ara-C </= 2g) for AML or MDS. They could have received hypomethylator agents, transfusions, hematopoietic growth factors or vitamins. Temporary prior measures such as apheresis or hydrea or one dose of ara-C </= 2g in order to safely control hyperleucocytosis prior to enrollment.
* Serum biochemical values with the following limits unless considered due to leukemia: ---Creatinine </= *5 mg/dl --- total bilirubin </= *5 mg/dL, unless increase is due to hemolysis or congenital disorder --- transaminases (SG PT) </= *5 x upper limit of normal (ULN).
* Ability to take oral medication.
* Ability to understand and provide signed informed consent.
* Baseline test of ejection fraction must be >/= 50%.
* Performance status < 3, unless directly related to disease process as determined by the Principal Investigator.
Exclusion Criteria:
* Subjects with APL.
* Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results.
* Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, IUD, diaphragm, abstinence, or condoms by their partner) over the entire course of the study. --- Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug. --- Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of nivolumab. --- Women must not be breastfeeding.
* Continued:Men who are sexually active with WOCBP must use acceptable birth control methods. Acceptable birth control methods include: oral or injectable hormonal birth control, intrauterine devices(IUDS), and double barrier methods (for example a condom in combination with spermicide). Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception.
* Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
* History of cardiac ventricular arrhythmias requiring anti-arrhythmic therapy within past 3 months.
* Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
* Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug.
* Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
* Active clinically serious and uncontrolled infection > CTCAE Grade 2 uncontrolled with antibiotics.
* Patients should be excluded if they have an active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
* Patients should be excluded if they are known to be positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
* Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
* History of allergy to study drug components.
* Prior immune checkpoint targeting drugs (e.g., anti PD1, and PDL1, anti-kir, anti CD*..etc) |
Study Objectives
Retrospective correlation of clinical outcomes data with mutational status in GIST subjects treated with sunitinib.
Intervention / Treatment
OTHER: non-interventional
| Inclusion Criteria:
* GIST subjects that participated in the A6181036 study that had mutational status data analyzed.
Exclusion Criteria:
* Subjects not participating in the A6181036 study |
Study Objectives
The purpose of this study is to determined the best scheme in paclitaxel and cisplatin，paclitaxel and fluorouracil，paclitaxel and carboplatin concurrent with radiotherapy for patients with local advanced esophageal Squamous Cell Carcinoma.
Intervention / Treatment
DRUG: Paclitaxel and Cisplatin, DRUG: Paclitaxel and Fluorouracil, DRUG: Paclitaxel and Carboplatin, RADIATION: Radiotherapy
| Inclusion criteria
To be eligible for this study, patient must fulfill all of the following criteria:
* Histologically confirmed esophageal squamous cell carcinoma
* Clinical stages II, III or IVa based on the 6th UICC-TNM classification
* No prior treatment of chemotherapy, radiotherapy or surgery against esophageal cancer, except for non-curative resection by EMR/ESD.
* Aged 18-75 years
* Adequate organ functions
* White blood cell (WBC) ≥3×109⁄L
* Absolute neutrophil counts (ANC) ≥*5×109⁄L
* Hemoglobin (Hb) ≥10g⁄dl
* Platelet (Plt) ≥100×109⁄L
* Total bilirubin <*5 upper limit of normal (ULN)
* Aspartate transaminase (AST) ≤*5 ULN
* Alanine aminotransferase (ALT) ≤*5 ULN
* Creatinine ≤*5 ULN
* ECOG PS of 0-2
* Life expectancy ≥3 months
* Written informed consent
Exclusion criteria Patients fulfilling any of the following criteria are ineligible for this study.
* Esophageal perforation or hematemesis
* Synchronous or metachronous malignancies (except for cutaneous (non-melanomas) carcinoma, thyroid papillary carcinoma, phase I seminoma or cervical carcinoma in situ curatively treated and disease free for a minimum of 3 months)
* Received thoracic, abdominal or craniocerebral surgery within 30 days
* Enrolled in other clinical trials within 30 days
* Unstable angina and/or congestive heart failure requiring hospitalization within 6 months
* Severe psychiatric disease
* Pregnancy, lactation or unwillingness to adopt contraception
* Drug addiction
* Acquired immune deficiency syndrome (AIDS) based upon current CDC definition
* Patients with hearing impairment or sensory-motor neuropathy of WHO grade > 1
* History of radiotherapy in the planning area
* Other ineligible conditions according to researchers |
Study Objectives
This is a prospective study that uses the treatment guideline of our chest surgery ICU. Investigators recruited 90 patients who underwent MIE in the National Taiwan University Hospital. The clinical data collected included vital signs (blood pressure, heart rate, respiratory patterns and frequencies, saturation of blood oxygen and carbon dioxide, etc.), blood tests, images and bronchoscopic analysis of sputum.
The goal of this study is to analyze common care problems and complications patients may encounter during the acute stage in ICU after MIE. By comparing the differences between the treatment group and the control group, investigators can interpret the role of HFNC.
Intervention / Treatment
DEVICE: High flow nasal cannula, HFNC
| Inclusion Criteria:
Clinical diagnosis of esophageal cancer. Underwent minimally invasive esophagectomy surgery.
Exclusion Criteria:
* The patient return to the intensive care unit without extubation * The patient who underwent tracheostomy surgery * Blood loss more than 1000c.c during the surgery * The patient who underwent CPR procedure or other emergent resuscitation management during surgery * The patient who is unable to communicate in words or speech
* |
Study Objectives
This pilot clinical trial studies how well tethered capsule endoscope works in screening patients with Barrett esophagus (BE), a condition where the lining of the esophagus has changed or has been replaced with abnormal cells that may lead to cancer also called esophageal cancer. In an attempt to prevent the progression from BE to esophageal cancer, patients undergo a standard procedure called esophagogastroduodenoscopy (EGD) where patients are sedated and the doctor uses an endoscope to examine the tissue in the esophagus. Tethered capsule endoscope is a tiny capsule with a laser scan inside and a very thin cord attached to it. Patients swallow the capsule and the thin cord keeps the capsule in specific area in the esophagus. After pictures of the lining of esophagus are taken, the capsule is removed using the thin cord. Tethered capsule endoscope may be able to identify tissue changes in patients with BE without the need for sedation or anesthesia, thus eliminating the associated risks and costs associated with EGD.
Intervention / Treatment
OTHER: Survey Administration, DEVICE: Tethered Capsule Endoscope
| Inclusion Criteria:
* Ability and willingness to provide written informed consent
* Scheduled for endoscopic screening and/or evaluation of Barrett's esophagus
Exclusion Criteria:
* Previous history of a swallowing disorder, such as scleroderma, achalasia, esophageal stricture or esophageal diverticulum
* Symptoms of dysphagia
* Suspicion or known history of gastrointestinal obstruction
* History of prior surgery on the oropharynx, neck, esophagus, or stomach
* Current diagnosis of cancer, unstable cardiovascular disease, end-stage liver or kidney disease, or other major medical illness
* Currently taking anticoagulant medications or clopidogrel
* Major physical disability which would prevent subject from transferring from a chair to a bed and sitting in an upright position
* Inability to abstain from taking anything by mouth for at least 6 hours
* Currently pregnant
* Expected to undergo magnetic resonance imaging (MRI) within two weeks following the study procedure |
Study Objectives
The primary purpose of this study is to determine if the administration of a higher dose would decrease the chance of tumor recurrence, compared to the risk of tumor recurrence with a lower dose. Most of the treatment will be given protons, but participants may receive a small portion of treatment with x-rays, because less radiation is given to the skin with x-rays. This study uses two slightly different doses of radiation It is not clear at this time which of the dose levels is better.
Intervention / Treatment
RADIATION: Charged Particle Radiation Therapy
| Inclusion Criteria:
* Biopsy proven chordoma. Slides must be reviewed prior to randomization by the central review pathologist
* Sites: Intercranial (sphenoid, clivus, petrous, basio-occiput) or cervical spine
* Boost target volume less than or equal to 150
* 18 years of age or older
* Karnofsky Performance Status > 50
* Neurologic Function of I or II
* No evidence of metastases
Exclusion Criteria:
* Previous radiation to the head or neck that would compromise the ability to deliver the prescribed treatment
* Concurrent or prior malignancy unless disease free for 5 or more years
* Evidence of metastatic disease
* Diabetes mellitus
* Major medical illness or psychiatric impairments that in the opinion of the investigator, will prevent administration or completion of the protocol therapy |
Study Objectives
This is a Phase 1 open-label, multicenter study to evaluate biomarkers for ZN-c5 in subjects with breast cancer
Intervention / Treatment
DRUG: ZN-c5
| Inclusion Criteria:
* Signed and dated ICF
* Age ≥ 18 years of age, either gender
* Females must be postmenopausal as defined by at least one of the following:
* Age ≥ 60 years;
* Age < 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and follicle stimulating hormone levels within the local laboratory's normal reference range for postmenopausal females;
* Documented bilateral oophorectomy
* Histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Adequate organ function defined as follows:
* Hematologic: Platelets ≥ 100 × 109/L; Hemoglobin ≥ *0 g/dL; Absolute neutrophil count ≥ *5 × 109/L (without platelet transfusion or any hematopoietic growth factors within previous 7 days of the hematologic laboratory values obtained at the Screening Visit)
* Hepatic: Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT)
≤ *5 × upper limit of normal (ULN); Total or conjugated bilirubin ≤ *5 × ULN
* Renal: Serum creatinine ≤ *5 × ULN or creatinine clearance (CrCl) ≥ 60 mL/min
Exclusion Criteria:
* Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy) within 28 days of the first administration of study drug
* Treatment with another investigational drug or other intervention within 28 days before the first administration of study drug
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral medication, including any unresolved nausea, vomiting, or diarrhea that is CTCAE v.*0 Grade > 1
* Myocardial infarction, symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months of study Day 1
* Uncontrolled inter-current illness
* History or evidence of clinically significant disorder, condition, or disease that, in the opinion of the Investigator would pose a risk to subject safety or interfere with the study evaluations, procedures, or completion |
Study Objectives
This single arm study will assess the maximum tolerated dose, and dose-limiting toxicities, of Xeloda administered concurrently with radiation therapy, in children with newly diagnosed diffuse intrinsic brain stem gliomas and high grade gliomas. Xeloda will be administered twice daily, at a starting dose of 500mg/m2 bid, beginning within 24 hours of the start of radiation therapy. Subsequent dose escalations will be in increments of 30%, using a standard dose escalation schema. Post-radiation therapy with Xeloda will continue after a 2 week break. The anticipated time on study treatment is 3-12 months, and the target sample size will not exceed 30 evaluable patients.
Intervention / Treatment
DRUG: capecitabine [Xeloda]
| Inclusion Criteria:
* patients >=3 and <=21 years of age;
* newly diagnosed non-disseminated brainstem glioma or non-disseminated high grade glioma;
* Karnofsky (if >16 years) or Lansky (if < 16 years) Performance Scale of >=50%;
* adequate organ function.
Exclusion Criteria:
* previous chemotherapy, radiation therapy, immunotherapy or bone marrow transplant;
* uncontrolled infection;
* known DPD deficiency. |
Study Objectives
This is a single arm, open-label, single center study evaluating the safety, feasibility, clinical efficacy and immunogenicity of GLA-SE administration to patients with Merkel cell carcinoma. Ten patients will be treated. The goal is for GLA-SE to assist the patient's own immune system in attacking the cancer cells.
Intervention / Treatment
BIOLOGICAL: GLA-SE
| Inclusion Criteria:
* Biopsy-confirmed Merkel cell carcinoma with metastatic or loco-regional disease.
* Patients must have at least one injectable lesion, defined as an easily palpable superficial lesion (cutaneous, subcutaneous or lymph nodal metastasis) that can be accurately localized, stabilized by palpation, and is superficial enough to enable IT injection.
* ECOG performance status score 0, 1 or 2
* ≥ 18 years of age
* Life expectancy of ≥ three months.
* Adequate neutrophil and platelet counts
* Adequate renal and hepatic function
* Willing to undergo pre-treatment lesion biopsy and post-treatment lesion biopsy
* Use of effective contraception
* Signed informed consent document
* Members of all genders, races and ethnic groups are eligible for this trial
Exclusion Criteria:
* Prior chemotherapy or a major surgical procedure within 3 weeks, or radiotherapy within 2 weeks prior to first study treatment
* No concurrent anti-cancer treatment (including topical agents such as imiquimod) or investigational agents
* Active, untreated brain metastases
* Pregnant or nursing
* Use of any systemic immunosuppressive agents
* Immunosuppressed patients
* Uncontrolled depression or other major psychiatric disorder |