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

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

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

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Allogeneic Adoptive Immunochemotherapy For Treatment Of Renal Cell Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Bone Marrow Transplantation Cancer Kidney Cancer

Drug Information available for: Cyclophosphamide Fludarabine Fludarabine monophosphate Campath Alemtuzumab

U.S. FDA Resources

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

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000328247, BCM-H-8447
Study First Received:	December 10, 2003
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00073879 History of Changes
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:

Antimetabolites
Urinary Tract Neoplasm
Kidney Cancer
Immunologic Factors
Urogenital Neoplasms
Fludarabine monophosphate
Cyclophosphamide
Urologic Neoplasms
Immunosuppressive Agents
Recurrence
Carcinoma
Renal Cancer

Urologic Diseases
Kidney Neoplasms
Alemtuzumab
Carcinoma, Renal Cell
Antineoplastic Agents, Alkylating
Fludarabine
Kidney Diseases
Antirheumatic Agents
Adenocarcinoma
Alkylating Agents
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Cyclophosphamide
Urologic Neoplasms
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Alemtuzumab
Therapeutic Uses
Kidney Diseases

Alkylating Agents
Neoplasms by Histologic Type
Fludarabine monophosphate
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Myeloablative Agonists
Carcinoma, Renal Cell
Fludarabine
Antineoplastic Agents, Alkylating
Adenocarcinoma
Antirheumatic Agents
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009