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

Primary Purpose

Kidney Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
alemtuzumab
graft-versus-tumor induction therapy
cyclophosphamide
fludarabine phosphate
allogeneic bone marrow transplantation
peripheral blood stem cell transplantation
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage IV renal cell cancer, recurrent renal cell cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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 PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified

Sites / Locations

  • Baylor College of Medicine

Outcomes

Primary Outcome Measures

Number of patients with treatment related mortality

Secondary Outcome Measures

Full Information

First Posted
December 10, 2003
Last Updated
January 27, 2015
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00073879
Brief Title
Fludarabine, Cyclophosphamide, and Alemtuzumab in Treating Patients With Recurrent or Metastatic Renal Cell Carcinoma (Kidney Cancer) Undergoing Allogeneic Stem Cell Transplantation
Official Title
Allogeneic Adoptive Immunochemotherapy For Treatment Of Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
April 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
stage IV renal cell cancer, recurrent renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
alemtuzumab
Intervention Type
Biological
Intervention Name(s)
graft-versus-tumor induction therapy
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
fludarabine phosphate
Intervention Type
Procedure
Intervention Name(s)
allogeneic bone marrow transplantation
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Primary Outcome Measure Information:
Title
Number of patients with treatment related mortality
Time Frame
100

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uday Popat, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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