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Conditioning Regimen in Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation

NCT00429026 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-03-04

Study results available
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Summary

Primary Objectives:

1. To compare the overall survival of metastatic renal cell carcinoma (RCC) patients undergoing HLA-matched related donor nonmyeloablative allogeneic hematopoietic stem cell transplantation (NST) using fludarabine-melphalan (FM) versus fludarabine-cyclophosphamide (FC) conditioning regimen.
2. To assess both cytotoxic T lymphocyte reactivity and antibodies activity against potential tumor antigenic peptides involved in graft-versus-RCC effect.

Secondary Objectives:

1. To study the patient characteristics of metastatic RCC patients who undergo NST and those who do not undergo NST.
2. To compare the incidence of Day-100 treatment-related mortality in FM group and FC group.

Conditions

  • Renal Cell Cancer

Interventions

DRUG

Fludarabine

25 mg/m\^2 intravenous (IV) daily for 5 Days

DRUG

Melphalan

70 mg/m\^2 IV Daily for 2 Days

DRUG

Cyclophosphamide

60 mg/kg IV Daily for 2 Days

PROCEDURE

Stem Cell Transplant

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using HLA-Matched Related Donor

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Naoto Ueno, MD, PhD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00429026 on ClinicalTrials.gov