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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

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ClinicalTrials.gov Identifier: NCT00073879
Recruitment Status : Completed
First Posted : December 11, 2003
Last Update Posted : January 29, 2015
Sponsor:
Information provided by (Responsible Party):
Helen Heslop, Baylor College of Medicine

Tracking Information
First Submitted Date  ICMJE December 10, 2003
First Posted Date  ICMJE December 11, 2003
Last Update Posted Date January 29, 2015
Study Start Date  ICMJE April 2003
Actual Primary Completion Date April 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January¬†27,¬†2015)
Number of patients with treatment related mortality [ Time Frame: 100 ]
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Not Applicable
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 Arms  ICMJE 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 Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2004
Actual Primary Completion Date April 2004   (Final data collection date for primary outcome measure)
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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00073879
Other Study ID Numbers  ICMJE CDR0000328247
BCM-H-8447
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Helen Heslop, Baylor College of Medicine
Study Sponsor  ICMJE Baylor College of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Uday Popat, MD Baylor College of Medicine
PRS Account Baylor College of Medicine
Verification Date January 2015

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