Status:
COMPLETED
Fludarabine, Cyclophosphamide, and Alemtuzumab in Treating Patients With Recurrent or Metastatic Renal Cell Carcinoma (Kidney Cancer) Undergoing Allogeneic Stem Cell Transplantation
Lead Sponsor:
Baylor College of Medicine
Conditions:
Kidney Cancer
Eligibility:
All Genders
Phase:
NA
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation...
Detailed Description
OBJECTIVES: * Determine the safety and feasibility of fludarabine, cyclophosphamide, and alemtuzumab in patients with recurrent or metastatic renal cell carcinoma undergoing HLA-matched allogeneic st...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
April 1 2004
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00073879
Start Date
April 1 2003
End Date
April 1 2004
Last Update
January 29 2015
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030