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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2005 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00073879

First received: December 10, 2003

Last updated: February 6, 2009

Last verified: January 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

December 10, 2003

Last Updated Date

February 6, 2009

Start Date ^ICMJE

April 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00073879 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Allogeneic Adoptive Immunochemotherapy For Treatment Of Renal Cell Carcinoma

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

Kidney Cancer

Intervention ^ICMJE

Biological: alemtuzumab
Biological: graft-versus-tumor induction therapy
Drug: cyclophosphamide
Drug: fludarabine phosphate
Procedure: allogeneic bone marrow transplantation
Procedure: peripheral blood stem cell transplantation

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00073879

Other Study ID Numbers ^ICMJE

CDR0000328247, BCM-H-8447

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Baylor College of Medicine

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Uday Popat, MD

Baylor College of Medicine

Information Provided By

National Cancer Institute (NCI)

Verification Date

January 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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