Allogeneic Stem Cell Transplantation of Renal Cell Cancer and Metastatic Melanoma After Non-Myeloablative Chemotherapy
18 Years
65 Years
Both
Kidney Cancer, Melanoma (Skin)
Trial Information
Allogeneic Stem Cell Transplantation of Renal Cell Cancer and Metastatic Melanoma After Non-Myeloablative Chemotherapy
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete Response Rate
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Todd M. Zimmerman, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Chicago
Authority:
United States: Federal Government
Study ID:
9672
NCT ID:
NCT00004135
Start Date:
February 1999
Completion Date:
August 2007
Related Keywords:
- Kidney Cancer
- Melanoma (Skin)
- stage IV renal cell cancer
- recurrent renal cell cancer
- stage IV melanoma
- recurrent melanoma
- Carcinoma, Renal Cell
- Kidney Neoplasms
- Melanoma
Name | Location |
|---|---|
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
