NCT00056095

Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer

Phase II Trial in Intrafamilial Allogeneic Cell Transplant in Patients With Metastatic Kidney Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
BIOLOGICAL	therapeutic allogeneic lymphocytes
DRUG	cyclophosphamide
DRUG	cyclosporine
DRUG	fludarabine phosphate
PROCEDURE	allogeneic bone marrow transplantation
PROCEDURE	peripheral blood stem cell transplantation

Timeline

• Start date: 2002-11-04
• Primary completion: 2008-02-13
• Completion: 2016-08-17
• First posted: 2003-03-07
• Last updated: 2021-02-24

Locations

26 sites across 1 country: France