Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer
- Conditions
- Kidney Cancer
- Interventions
- Procedure: allogeneic bone marrow transplantationBiological: therapeutic allogeneic lymphocytesProcedure: peripheral blood stem cell transplantation
- Registration Number
- NCT00056095
- Lead Sponsor
- UNICANCER
- 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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Allograft (compatible non-family member) allogeneic bone marrow transplantation - Allograft (compatible non-family member) peripheral blood stem cell transplantation - Allograft (compatible family member) allogeneic bone marrow transplantation - Allograft (compatible family member) therapeutic allogeneic lymphocytes - Allograft (compatible family member) cyclophosphamide - Allograft (compatible family member) peripheral blood stem cell transplantation - Allograft (compatible family member) cyclosporine - Allograft (compatible family member) fludarabine phosphate -
- Primary Outcome Measures
Name Time Method Survival rate at 18 months Objective rate of response Post-transplant immunological reactions and recuperation Antitumoral activity
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (26)
Centre Paul Papin
🇫🇷Angers, France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
🇫🇷Besancon, France
Centre Hospitalier Regional et Universitaire d'Angers
🇫🇷Angers, France
Chu-Hopital Gabriel Montpied
🇫🇷Clermont-Ferrand, France
Hopital Saint Andre
🇫🇷Bordeaux, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Centre Hospital Universitaire Hop Huriez
🇫🇷Lille, France
CHU de Grenoble - Hopital Michallon
🇫🇷Grenoble, France
Centre Oscar Lambret
🇫🇷Lille, France
Centre Hospital Regional Universitaire de Limoges
🇫🇷Limoges, France
Centre Leon Berard
🇫🇷Lyon, France
Hopital Edouard Herriot - Lyon
🇫🇷Lyon, France
Hopital Lapeyronie-CHU Montpellier
🇫🇷Montpellier, France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
🇫🇷Montpellier, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Hopital de l'Archet CHU de Nice
🇫🇷Nice, France
Hopital Haut Leveque
🇫🇷Pessac, France
Centre Hospitalier Universitaire de Rennes
🇫🇷Rennes, France
Institut Curie Hopital
🇫🇷Paris, France
Hopital Jean Bernard
🇫🇷Poitiers, France
Centre Alexis Vautrin
🇫🇷Vandoeuvre-les-Nancy, France
Centre Henri Becquerel
🇫🇷Rouen, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Hopitaux de Brabois
🇫🇷Vandoeuvre-Les-Nancy, France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
🇫🇷Marseille, France
Centre Eugene Marquis
🇫🇷Rennes, France