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Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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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:

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: Phase II Trial in Intrafamilial Allogeneic Cell Transplant in Patients With Metastatic Kidney Cancer
Study Start Date : December 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

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

Eligibility Criteria
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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
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
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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 ClinicalTrials.gov identifier (NCT number): NCT00056095


Locations
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France
Centre Hospitalier Regional et Universitaire d'Angers Recruiting
Angers, France, 49033
Contact: Norbert Ifrah, MD    33-2-41-35-4472      
Centre Paul Papin Recruiting
Angers, France, 49100
Contact: Remy Delva    33-49-800-918-507      
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz Recruiting
Besancon, France, 25030
Contact: Contact Person    33-81-668-240      
Hopital Saint Andre Recruiting
Bordeaux, France, 33075
Contact: Alain Ravaud, MD, PhD    33-5-5679-5808    alain.ravaud@chu-bordeaux.fr   
Chu-Hopital Gabriel Montpied Recruiting
Clermont-Ferrand, France, 63003
Contact: Laurent Guy, MD    33-0473-750-750    lguy@chu-clermontferrand.fr   
Centre Jean Perrin Recruiting
Clermont-Ferrand, France, 63011
Contact: Jean Olivier    33-73-278-080      
CHU de Grenoble - Hopital Michallon Recruiting
Grenoble, France, 38043
Contact: Frederic Garban, MD, PhD    33-4-7676-5028      
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Armelle Caty, MD    33-32-029-5959    acaty@o-lambret.fr   
Centre Hospital Universitaire Hop Huriez Recruiting
Lille, France, 59037
Contact: J.P. Jouet, MD    33 3 20 444197    jpjouet@chru-lille.fr   
Centre Hospital Regional Universitaire de Limoges Recruiting
Limoges, France, 87042
Contact: Dominique Bordessoule, MD, PhD    33-5-5505-6642    bordessoule@unilim.fr   
Centre Leon Berard Recruiting
Lyon, France, 69373
Contact: Sylvie Negrier, MD    33-4-7878-2751    negrier@lyon.fnclcc.fr   
Hopital Edouard Herriot - Lyon Recruiting
Lyon, France, 69437
Contact: Mauricette Michallet, MD    33-472117401      
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes Recruiting
Marseille, France, 13273
Contact: Didier Blaise, MD    33-4-91-22-37-54    blaised@marseille.fnclcc.fr   
Hopital Lapeyronie-CHU Montpellier Recruiting
Montpellier, France, 34295
Contact: Eric Legouffe, MD    33-4-67-33-80-79    e-legouffe@chu-montpellier.fr   
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: Stephane Culine, MD    33-4-6761-3755    stculine@valdorel.fnclcc.fr   
Centre Antoine Lacassagne Recruiting
Nice, France, 06189
Contact: Antoine Thyss, MD    33-04-9203-1538    antoine.thyss@cal.nice.fnclcc.fr   
Hopital de l'Archet CHU de Nice Recruiting
Nice, France, F-06202
Contact: Contact Person    33-49-203-9267      
Institut Curie Hopital Recruiting
Paris, France, 75248
Contact: Pierre T. Dorval, MD    33-1-44-324-679    thierry.dorval@curie.net   
Hopital Haut Leveque Recruiting
Pessac, France, 33604
Contact: Reza Tabrizi, MD    33-57-656-511      
Hopital Jean Bernard Recruiting
Poitiers, France, 86021
Contact: Jean-Marc Tourani, MD    33-549-444-534    jm.tourani@chu.poitiers.frs.fr   
Centre Hospitalier Universitaire de Rennes Recruiting
Rennes, France, 35033
Contact: Thiery Lamy, MD, PhD    33-2-99-28-42-91    thierry.lamy@univ-rennes1.fr   
Centre Eugene Marquis Recruiting
Rennes, France, 35042
Contact: Brigitte Laguerre    33-2-9925-3000      
Centre Henri Becquerel Recruiting
Rouen, France, 76038
Contact: Nathalie Contentin    33-2-3208-2222      
Centre Alexis Vautrin Recruiting
Vandoeuvre-les-Nancy, France, 54511
Contact: Lionnel Geoffrois, MD    33-3-8359-8400      
Hopitaux de Brabois Recruiting
Vandoeuvre-Les-Nancy, France, 54511
Contact: Pierre Bordigoni    Not Available      
Institut Gustave Roussy Recruiting
Villejuif, France, F-94805
Contact: Jean-Henri Bourhis, MD, PhD    33-1-42-11-4507    jhb@igr.fr   
Sponsors and Collaborators
UNICANCER
Investigators
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Study Chair: Didier Blaise, MD Institut Paoli-Calmettes
More Information
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ClinicalTrials.gov Identifier: NCT00056095     History of Changes
Other Study ID Numbers: CDR0000271936
FRE-FNCLCC-GETUG-11/0105
EU-20234
First Posted: March 7, 2003    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: December 2006
Keywords provided by National Cancer Institute (NCI):
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
Neoplasms
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cyclosporine
Cyclophosphamide
Fludarabine
 Fludarabine phosphate
Cyclosporins
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