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Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer

2014-08-27 03:57:25 | BioPortfolio

Summary

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy.

PURPOSE: Randomized phase I/II trial to study the effectiveness of peripheral stem cell transplantation in treating patients who have breast cancer or hematologic cancer.

Description

OBJECTIVES:

- Determine the toxicity of ex vivo expanded megakaryocytes (EVE MK) as a supplement to peripheral blood stem cell (PBSC) transplantation in patients with breast cancer or hematologic malignancies.

- Compare the effect of this treatment regimen on platelet recovery and platelet function in these patients vs historical controls.

- Compare the frequency of malignant cells in the EVE MK vs the uncultured PBSC collection in these patients.

- Determine the optimal time of MK harvest for the production of platelets in vivo.

- Determine the required number of MKs for clinical efficacy in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 durations of CD34+ culture times (6 days vs 9 days).

After an initial harvest of filgrastim (G-CSF)-mobilized autologous peripheral blood stem cells (PBSC) for transplantation, patients receive one additional dose of G-CSF and undergo one additional apheresis. The CD34+ cells are cultured in the presence of recombinant human thrombopoietin, interleukin-3, and flt3 ligand to expand megakaryocytes. Patients then undergo treatment with high-dose chemotherapy (and, in some cases, total body irradiation) followed by reinfusion of the conventional PBSC harvest and the ex vivo expanded megakaryocytes.

Patients are followed until blood counts recover.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Study Design

Allocation: Randomized, Control: Active Control, Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

filgrastim, recombinant flt3 ligand, recombinant human thrombopoietin, recombinant interleukin-3, in vitro-treated peripheral blood stem cell transplantation

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago
Illinois
United States
60611

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:57:25-0400

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Medical and Biotech [MESH] Definitions

The large scale production of pharmaceutically important and commercially valuable RECOMBINANT PROTEINS.

Techniques utilizing cells that express RECOMBINANT FUSION PROTEINS engineered to translocate through the CELL MEMBRANE and remain attached to the outside of the cell.

The in vitro fusion of GENES by RECOMBINANT DNA techniques to analyze protein behavior or GENE EXPRESSION REGULATION, or to merge protein functions for specific medical or industrial uses.

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