Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Any age	Other	BCM-H-8447 NCT00073879

Objectives

1. 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.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

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

• FEV₁, 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

Expected Enrollment

A total of 20 patients (10 with HLA-identical related donors and 10 with matched unrelated donors) will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Dan L. Duncan Cancer Center at Baylor College of Medicine

Uday Popat, MD, Protocol chair		Ph: 713-394-6250

Registry Information
Official Title		Allogeneic Adoptive Immunochemotherapy For Treatment Of Renal Cell Carcinoma
Trial Start Date		2003-04-25
Registered in ClinicalTrials.gov		NCT00073879
Date Submitted to PDQ		2003-08-06
Information Last Verified		2005-01-03

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