Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer
Recruitment status was: Recruiting
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.
Biological: therapeutic allogeneic lymphocytes
Drug: fludarabine phosphate
Procedure: allogeneic bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Treatment
|Official Title:||Phase II Trial in Intrafamilial Allogeneic Cell Transplant in Patients With Metastatic Kidney Cancer|
- 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 ]
|Study Start Date:||December 2002|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00056095
|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|
|Study Chair:||Didier Blaise, MD||Institut Paoli-Calmettes|