NCT00027573

Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer

Adoptive Immunotherapy by Allogeneic Stem Cell Transplantation for Metastatic Renal Cell Carcinoma: A Phase II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by donor peripheral stem cell transplantation in treating patients who have metastatic or unresectable kidney cancer.

Detailed description

OBJECTIVES: * Determine the overall response rate and overall and disease-free survival of patients with unresectable or metastatic renal cell cancer treated with fludarabine and cyclophosphamide followed by allogeneic peripheral blood stem cell transplantation. * Determine the toxicity and treatment-related mortality of this regimen in these patients. * Determine the percentage of donor chimerism in patients treated with this regimen.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim
BIOLOGICAL	therapeutic allogeneic lymphocytes
DRUG	cyclophosphamide
DRUG	fludarabine phosphate
DRUG	methotrexate
DRUG	tacrolimus
PROCEDURE	peripheral blood stem cell transplantation

Timeline

• Start date: 2001-10-01
• Primary completion: 2006-06-01
• Completion: 2006-06-01
• First posted: 2003-01-27
• Last updated: 2016-07-14

Locations

6 sites across 1 country: United States