Allogeneic Adoptive Immunochemotherapy For Treatment Of Renal Cell Carcinoma
N/A
N/A
Both
Kidney Cancer
Trial Information
Allogeneic Adoptive Immunochemotherapy For Treatment Of Renal Cell Carcinoma
OBJECTIVES:
- Determine the safety and feasibility of fludarabine, cyclophosphamide, and alemtuzumab
in patients with recurrent or metastatic renal cell carcinoma undergoing HLA-matched
allogeneic stem cell transplantation.
OUTLINE: This is a pilot, multicenter study.
- Conditioning: Patients receive fludarabine IV over 30 minutes on days -6 to -2,
cyclophosphamide IV over 2 hours on days -6 and -5, and alemtuzumab IV on days -4 to
-2.
- Allogeneic transplantation: Allogeneic stem cells are infused on day 0. Patients
receive graft-vs-host disease prophylaxis with tacrolimus IV or orally for
approximately 30 days.
Patients are followed weekly for 100 days and then at 6, 12, 18, 24, 36, 48, and 60 months
after transplantation.
PROJECTED ACCRUAL: A total of 20 patients (10 with HLA-identical related donors and 10 with
matched unrelated donors) will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of recurrent or metastatic renal cell carcinoma
- Failed interleukin-2 (IL-2)-based therapy OR intolerant to IL-2
- Clinically evident and followable disease
- Availability of 1 of the following compatible donors:
- Related HLA-identical or 1-Ag mismatched donor
- Unrelated HLA-A, B, DRB1-matched donor
PATIENT CHARACTERISTICS:
Age
- Any age
Performance status
- Karnofsky 70-100%
Life expectancy
- No concurrent illness that severely limits life expectancy
Hematopoietic
- Not specified
Hepatic
- No episode of hepatitis within the past month
- No evidence of chronic active hepatitis or cirrhosis
Renal
- Creatinine no greater than 2 mg/dL
Cardiovascular
- LVEF at least 40%
- No uncontrolled arrhythmias
- No symptomatic cardiac disease
Pulmonary
- FEV_1, FVC, and DLCO at least 50% of predicted (unless due to metastatic disease)
Other
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study
participation
- No active infection
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Uday Popat, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Baylor College of Medicine
Authority:
United States: Federal Government
Study ID:
CDR0000328247
NCT ID:
NCT00073879
Start Date:
April 2003
Completion Date:
Related Keywords:
- Kidney Cancer
- stage IV renal cell cancer
- recurrent renal cell cancer
- Carcinoma
- Carcinoma, Renal Cell
- Kidney Neoplasms
Name | Location |
|---|---|
| Baylor College of Medicine | Houston, Texas 77030 |
