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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 : Completed
First Posted : March 7, 2003
Last Update Posted : February 24, 2021
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Kidney Cancer Biological: therapeutic allogeneic lymphocytes Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial in Intrafamilial Allogeneic Cell Transplant in Patients With Metastatic Kidney Cancer
Actual Study Start Date : November 4, 2002
Actual Primary Completion Date : February 13, 2008
Actual Study Completion Date : August 17, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Arm Intervention/treatment
Experimental: Allograft (compatible family member) Biological: therapeutic allogeneic lymphocytes
Drug: cyclophosphamide
Drug: cyclosporine
Drug: fludarabine phosphate
Procedure: allogeneic bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Allograft (compatible non-family member) Procedure: allogeneic bone marrow transplantation
Procedure: peripheral blood stem cell transplantation

Primary Outcome Measures :
  1. Survival rate at 18 months
  2. Objective rate of response
  3. Post-transplant immunological reactions and recuperation
  4. Antitumoral activity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00056095

Show Show 26 study locations
Sponsors and Collaborators
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Study Chair: Didier Blaise, MD Institut Paoli-Calmettes
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Responsible Party: UNICANCER Identifier: NCT00056095    
Other Study ID Numbers: UC-0160/0105
FRE-FNCLCC-GETUG-11/0105 ( Other Identifier: FNCLCC )
EU-20234 ( Other Identifier: European union )
First Posted: March 7, 2003    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UNICANCER:
recurrent renal cell cancer
stage IV renal cell cancer
Additional relevant MeSH terms:
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Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fludarabine phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Enzyme Inhibitors
Antifungal Agents