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Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00056095
Recruitment Status : Unknown
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : March 7, 2003
Last Update Posted : February 9, 2009
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE March 6, 2003
First Posted Date  ICMJE March 7, 2003
Last Update Posted Date February 9, 2009
Study Start Date  ICMJE December 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2007)
  • Survival rate at 18 months
  • Objective rate of response
  • Post-transplant immunological reactions and recuperation
  • Antitumoral activity
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00056095 on 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 Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer
Official Title  ICMJE Phase II Trial in Intrafamilial Allogeneic Cell Transplant in Patients With Metastatic Kidney Cancer
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: This phase II trial is studying how well allogeneic stem cell transplant works in treating patients with metastatic kidney cancer.

Detailed Description


  • Determine the 18-month survival rate of patients with metastatic renal cell carcinoma treated with allogeneic stem cell transplantation.
  • Determine the objective rate of response of patients treated with this regimen.
  • Determine post-transplant immunological reactions and recuperation of patients treated with this regimen.
  • Determine the antitumoral activity of this regimen in these patients.

OUTLINE: This is a non-randomized, multicenter study. Patients are assigned to 1 of 2 treatment groups based on availability of a compatible family member for stem cell transplantation.

  • Group I: Patients with a compatible family donor receive conditioning chemotherapy comprising cyclophosphamide IV over 2 hours on days -7 and -6 and fludarabine IV once daily on days -5 to -1. Patients undergo filgrastim (G-CSF)-mobilized allogeneic stem cell transplantation on day 0. Patients also receive immunosuppression therapy with cyclosporine beginning on day -2. Patients who have persistent or progressive disease, mixed chimerism, and no evidence of grade 2 or greater graft-vs-host disease, and have been off immunosuppression therapy for 1-2 weeks receive donor lymphocyte infusion on days 7 and 21.
  • Group II: Patients without a compatible family donor receive treatment (immunotherapy, vaccination therapy, or chemotherapy) at the discretion of the treating physician.

Patients are followed every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 170 patients (60 patients for group I and 110 patients for group II) will be accrued for this study within 3 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Primary Purpose: Treatment
Condition  ICMJE Kidney Cancer
Intervention  ICMJE
  • Biological: therapeutic allogeneic lymphocytes
  • Drug: cyclophosphamide
  • Drug: cyclosporine
  • 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 Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 8, 2006)
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE


  • Histologically confirmed metastatic renal cell carcinoma
  • No sarcomatoid, pure papillary, or Bellini renal cell cancer
  • Measurable and/or evaluable disease
  • Disease progression after at least 1 immunotherapy regimen for metastatic disease
  • Localized metastases allowed provided the following are true:

    • At least 3 months since prior treatment for metastases
    • Not considered likely to influence outcome of transplantation
  • No brain metastases unless treated surgically or radiologically and MRI normal
  • Sufficiently healthy, HLA-compatible family member must be available as donor for patients undergoing stem cell transplantation



  • 18 to 65

Performance status

  • ECOG 0-1

Life expectancy

  • More than 6 months


  • Platelet count at least 100,000/mm^3


  • Transaminases less than 1.5 times upper limit of normal (ULN)*
  • Bilirubin less than 1.5 times ULN* NOTE: *Unless due to Gilbert's disease


  • No renal insufficiency
  • Calcium less than 10.4 mg/dL
  • Creatinine clearance greater than 50 mL/min


  • Ejection fraction greater than 50%


  • No DLCO that would preclude fludarabine or busulfan therapy


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No physical obstacle to receiving study treatment
  • No known autoimmune disease
  • No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
  • No uncontrolled bacterial, viral, or fungal infection
  • No prior or concurrent psychiatric disease
  • HIV negative
  • HTLV1 negative


Biologic therapy

  • See Disease Characteristics


  • No tolerance to fludarabine and busulfan

Endocrine therapy

  • No concurrent corticosteroids


  • Not specified


  • Not specified
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (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 France
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00056095
Other Study ID Numbers  ICMJE CDR0000271936
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Didier Blaise, MD Institut Paoli-Calmettes
PRS Account National Cancer Institute (NCI)
Verification Date December 2006

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