Fludarabine, Cyclophosphamide, and Alemtuzumab in Treating Patients With Recurrent or Metastatic Renal Cell Carcinoma (Kidney Cancer) Undergoing Allogeneic Stem Cell Transplantation

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: All

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 may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells can reject the body's normal tissues. Alemtuzumab and tacrolimus may prevent this from happening.

PURPOSE: Phase II trial to study the effectiveness of combining fludarabine and cyclophosphamide with alemtuzumab in treating patients who are undergoing allogeneic stem cell transplantation for recurrent or metastatic renal cell carcinoma (kidney cancer).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Treatments: Alemtuzumab; Cyclophosphamide; Fludarabine; Fludarabine phosphate

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