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

Purpose

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	Intervention	Phase
Kidney Cancer	Drug: alemtuzumab Drug: cyclophosphamide Drug: fludarabine phosphate Procedure: allogeneic bone marrow transplantation Procedure: graft-versus-tumor induction therapy Procedure: peripheral blood stem cell transplantation	Phase II

MedlinePlus related topics:

Bone Marrow Transplantation Cancer Kidney Cancer

Drug Information available for:

Cyclophosphamide Fludarabine Fludarabine monophosphate Alemtuzumab Campath

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

Official Title:	Allogeneic Adoptive Immunochemotherapy For Treatment Of Renal Cell Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

April 2003

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073879

Locations


United States, Texas
	Baylor College of Medicine
	Houston, Texas, United States, 77030

Sponsors and Collaborators

Baylor College of Medicine

Investigators


Study Chair:	Uday Popat, MD	Baylor College of Medicine

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000328247, BCM-H-8447
First Received:	December 10, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00073879
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IV renal cell cancer

recurrent renal cell cancer

Study placed in the following topic categories:

Urogenital Neoplasms

Fludarabine monophosphate

Cyclophosphamide

Renal cancer

Urologic Neoplasms

Kidney cancer

Recurrence

Carcinoma

Urologic Diseases

Kidney Neoplasms

Alemtuzumab

Carcinoma, Renal Cell

Fludarabine

Kidney Diseases

Adenocarcinoma

Urinary tract neoplasm

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites

Antimetabolites, Antineoplastic

Neoplasms by Histologic Type

Immunologic Factors

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Physiological Effects of Drugs

Immunosuppressive Agents

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Therapeutic Uses

Myeloablative Agonists

Antineoplastic Agents, Alkylating

Antirheumatic Agents

Alkylating Agents

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Baylor College of Medicine
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00073879