Peripheral Stem Cell Transplantation With or Without Stromagen Following

Status Completed

Clinical Trial Summary

RATIONALE: Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells. It is not yet known whether Stromagen improves the success of stem cell transplantation in women with breast cancer.

PURPOSE: Randomized phase I/II trial to study the effectiveness of Stromagen during stem cell transplantation following chemotherapy in treating women with metastatic breast cancer.

Clinical Trial Description

OBJECTIVES: I. Determine the safety of expanded mesenchymal stem cells (Stromagen) infusion and autologous CD34+ peripheral blood stem cells transplantation after high dose chemotherapy in women with metastatic breast cancer. II. Compare the time to neutrophil and platelet engraftment in patients receiving different doses of Stromagen. III. Evaluate the immune reconstitution of these patients after this therapy.

OUTLINE: This is a randomized, placebo controlled, blinded study. Patients are randomly assigned to one of three treatment arms. All patients undergo mobilization of peripheral blood stem cells (PBSC) using cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1, and filgrastim (G-CSF) subcutaneously beginning on day 4 and continuing until completion of leukapheresis. PBSC and bone marrow cells are collected and CD34 positive cells are then selected. About 4 weeks later, patients receive high dose chemotherapy. Cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours are administered on days -7 to -4. Patients then receive placebo or one of two doses of expanded mesenchymal stem cells (Stromagen) IV on day -1 and CD34+ selected PBSC IV over 2 hours on day 0. Patients are followed at 6 weeks and 12 weeks, than at 1 year.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study. ;

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00003877
Study type	Interventional
Source	Roswell Park Cancer Institute
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	September 1998
Completion date	December 2000

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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 With or Without Stromagen Following Chemotherapy in Treating Women With Metastatic Breast Cancer

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms