Allogeneic Stem Cell Transplantation of Renal Cell Cancer and Metastatic Melanoma After Non-Myeloablative Chemotherapy
filgrastim
+ therapeutic allogeneic lymphocytes
+ cyclophosphamide
Urogenital Diseases+22
+ Adenocarcinoma
+ Carcinoma
Treatment Study
Summary
Study start date: February 1, 1999
Actual date on which the first participant was enrolled.OBJECTIVES: Evaluate the safety of nonmyeloablative chemotherapy followed by allogeneic peripheral blood stem cell transplantation in patients with metastatic renal cell carcinoma or melanoma. Determine the incidence and severity of all adverse events related to this treatment regimen in this patient population. Determine the efficacy of this treatment regimen in terms of tumor regression, response duration, progression free survival, and overall survival in these patients. Measure the resulting chimerism and immune reconstitution in these patients after this treatment regimen and correlate with clinical response. OUTLINE: Patients receive fludarabine IV over 30 minutes on days -8 through -4 and cyclophosphamide IV over 1 hour on days -3 and -2. Immediately following each daily donor leukapheresis, patients receive allogeneic peripheral blood stem cells (PBSC) IV over 15 minutes beginning on day 0 and continuing until the target cells are collected. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 5 and continuing until blood counts recover. If no graft versus host disease has developed within 4 weeks of allogeneic PBSC transplantation, patients with disease progression or recurrence who have residual donor hematopoiesis on chimerism analysis may receive donor T lymphocytes IV over 30 minutes. Patients may receive an additional course of donor T lymphocytes at the investigator's discretion. Patients are followed at days 30 and 100, and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 10-38 patients will be accrued for this study within 2.5 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.19 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic renal cell carcinoma or melanoma that is not potentially curable by surgery Evaluable disease or bidimensionally measurable disease on physical examination, chest x-ray, CT scan, or MRI Measurable disease by radiography must be reproducible Bony disease or effusions not measurable No active CNS disease currently receiving radiotherapy or steroids No effusion or ascites of more than 1 liter prior to drainage HLA 5/6 or 6/6 matched sibling donor available No known hypersensitivity to E. coli derived products No active infection No health condition that would preclude donation PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: CALGB 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 g/dL No active hepatitis Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than 50 mL/min Cardiovascular: LVEF at least 50% Pulmonary: DLCO at least 50% of predicted Other: No active infection HIV negative No psychological problem that would preclude study compliance No known hypersensitivity to E. coli derived products Not pregnant or nursing Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior systemic chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Chicago Cancer Research Center
Chicago, United StatesOpen University of Chicago Cancer Research Center in Google Maps