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Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00056095
First received: March 6, 2003
Last updated: February 6, 2009
Last verified: December 2006
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: Phase II Trial in Intrafamilial Allogeneic Cell Transplant in Patients With Metastatic Kidney Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Survival rate at 18 months [ Designated as safety issue: No ]
  • Objective rate of response [ Designated as safety issue: No ]
  • Post-transplant immunological reactions and recuperation [ Designated as safety issue: No ]
  • Antitumoral activity [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: December 2002
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 to 65

Performance status

  • ECOG 0-1

Life expectancy

  • More than 6 months

Hematopoietic

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

Hepatic

  • 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

Renal

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

Cardiovascular

  • Ejection fraction greater than 50%

Pulmonary

  • No DLCO that would preclude fludarabine or busulfan therapy

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics

Chemotherapy

  • No tolerance to fludarabine and busulfan

Endocrine therapy

  • No concurrent corticosteroids

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056095

Locations
France
Centre Hospitalier Regional et Universitaire d'Angers
Angers, France, 49033
Centre Paul Papin
Angers, France, 49100
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besancon, France, 25030
Hopital Saint Andre
Bordeaux, France, 33075
Chu-Hopital Gabriel Montpied
Clermont-Ferrand, France, 63003
Centre Jean Perrin
Clermont-Ferrand, France, 63011
CHU de Grenoble - Hopital Michallon
Grenoble, France, 38043
Centre Oscar Lambret
Lille, France, 59020
Centre Hospital Universitaire Hop Huriez
Lille, France, 59037
Centre Hospital Regional Universitaire de Limoges
Limoges, France, 87042
Centre Leon Berard
Lyon, France, 69373
Hopital Edouard Herriot - Lyon
Lyon, France, 69437
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Hopital Lapeyronie-CHU Montpellier
Montpellier, France, 34295
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Centre Antoine Lacassagne
Nice, France, 06189
Hopital de l'Archet CHU de Nice
Nice, France, F-06202
Institut Curie Hopital
Paris, France, 75248
Hopital Haut Leveque
Pessac, France, 33604
Hopital Jean Bernard
Poitiers, France, 86021
Centre Hospitalier Universitaire de Rennes
Rennes, France, 35033
Centre Eugene Marquis
Rennes, France, 35042
Centre Henri Becquerel
Rouen, France, 76038
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Hopitaux de Brabois
Vandoeuvre-Les-Nancy, France, 54511
Institut Gustave Roussy
Villejuif, France, F-94805
Sponsors and Collaborators
UNICANCER
Investigators
Study Chair: Didier Blaise, MD Institut Paoli-Calmettes
  More Information

ClinicalTrials.gov Identifier: NCT00056095     History of Changes
Other Study ID Numbers: CDR0000271936  FRE-FNCLCC-GETUG-11/0105  EU-20234 
Study First Received: March 6, 2003
Last Updated: February 6, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent renal cell cancer
stage IV renal cell cancer

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cyclophosphamide
Cyclosporins
Cyclosporine
Fludarabine phosphate
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on December 09, 2016