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

Sponsor

Baylor College of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT00073879

Collaborator

(none)

Location

Duration (Months)

Study Details

Study Description

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 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).

Condition or Disease	Intervention/Treatment	Phase
Kidney Cancer	Biological: alemtuzumab Biological: graft-versus-tumor induction therapy Drug: cyclophosphamide Drug: fludarabine phosphate Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation	N/A

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 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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

Allogeneic Adoptive Immunochemotherapy For Treatment Of Renal Cell Carcinoma

Study Start Date :

Apr 1, 2003

Actual Primary Completion Date :

Apr 1, 2004

Actual Study Completion Date :

Apr 1, 2004

Outcome Measures

Primary Outcome Measures

Number of patients with treatment related mortality [100]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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