drugset / Trial / NCT00997529

Mini Allo Stem Cell Transplantation for the Treatment of Solid Tumors

NCT00997529

Non-randomizedSingle-groupOpen-labelTreatment

Summary

A major focus of recent research has been the development of effective ways of sensitizing the patient's immune system to recognize the cancer as foreign. Allogeneic stem cell transplantation represents a novel way of potentially achieving this goal. There is recent evidence that non-myeloablative allogeneic stem cell transplantation provides effective therapy for patients with metastatic renal cell carcinoma. Based on the preliminary reports from other investigators treating patient with breast and ovarian cancer, the investigators of this study would propose treating an expanded cohort of patients with any metastatic solid tumor. The principal endpoints of the trial will include incidence of durable engraftment, quality of hematopoietic and immune reconstitution, extent of donor chimerism, incidence and severity of acute and chronic graft versus host disease (GVHD), and incidence of long-term disease free survival (DFS). The investigators will evaluate the tumor response of patients with stable or progressive disease post-transplant to donor lymphocyte infusions (DLI). The investigators will also study the effects of DLI on T-cell immunity in the recipients.

Timeline

Start
2000-11
Primary completion
2007-11
Completion
2010-06

Drugs

EvaluationDrugModalityDoseRoute
Background Cyclophosphamide Other / unclassified 45 mg/kg
Background Cyclophosphamide Other / unclassified 60 mg/kg
Background Fludarabine Small molecule 25 mg/m2

Indications