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

This study has been completed.
Information provided by (Responsible Party):
Helen Heslop, Baylor College of Medicine
ClinicalTrials.gov Identifier:
First received: December 10, 2003
Last updated: January 27, 2015
Last verified: January 2015

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
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

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

Resource links provided by NLM:

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Number of patients with treatment related mortality [ Time Frame: 100 ] [ Designated as safety issue: Yes ]

Study Start Date: April 2003
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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



  • Any age

Performance status

  • Karnofsky 70-100%

Life expectancy

  • No concurrent illness that severely limits life expectancy


  • Not specified


  • No episode of hepatitis within the past month
  • No evidence of chronic active hepatitis or cirrhosis


  • Creatinine no greater than 2 mg/dL


  • LVEF at least 40%
  • No uncontrolled arrhythmias
  • No symptomatic cardiac disease


  • FEV_1, FVC, and DLCO at least 50% of predicted (unless due to metastatic disease)


  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • No active infection
  • HIV negative


Biologic therapy

  • See Disease Characteristics


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00073879

United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Study Chair: Uday Popat, MD Baylor College of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Helen Heslop, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00073879     History of Changes
Other Study ID Numbers: CDR0000328247, BCM-H-8447
Study First Received: December 10, 2003
Last Updated: January 27, 2015
Health Authority: United States: Federal Government

Keywords provided by Baylor College of Medicine:
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Kidney Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Fludarabine phosphate
Alkylating Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 06, 2015