Peripheral Stem Cell Transplantation in Treating Patients With Breast

Status Completed

Clinical Trial 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.

Clinical Trial 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, Primary Purpose: Treatment

Related Conditions & MeSH terms

Breast Cancer
Breast Neoplasms
Leukemia
Lymphoma
Multiple Myeloma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic-Myeloproliferative Diseases
Myelodysplastic/Myeloproliferative Diseases
Myeloproliferative Disorders
Neoplasms, Plasma Cell
Plasmacytoma

Clinical Trial Details

NCT number	NCT00006225
Study type	Interventional
Source	Northwestern University
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	November 1999
Completion date	January 2004

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms