Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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).

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Dan L. Duncan Cancer Center at Baylor College of Medicine

Uday Popat, MD

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00073879
Information obtained from ClinicalTrials.gov on December 14, 2011

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