Expired Study
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Chicago, Illinois 60611


Purpose:

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.


Study summary:

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.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of carcinoma of the breast or hematologic malignancies - No metastases to bone marrow - Planned high-dose chemotherapy with autologous peripheral blood stem cell transplantation - At least 2.0 million CD34+ cells/kg collected - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 to 60 Sex: - Female or male Menopausal status: - Not specified Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count greater than 1,500/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - SGOT or SGPT less than 2.5 times upper limit of normal (ULN) - Bilirubin less than 2.5 times ULN (except in Gilbert's syndrome) - Alkaline phosphatase less than 2.5 times ULN - No active hepatitis B or C Renal: - Creatinine clearance greater than 50 mL/min Cardiovascular: - Normal ejection fraction Pulmonary: - DLCO at least 50% predicted - FEV_1 and/or FVC at least 75% predicted Other: - No concurrent serious nonneoplastic disease that would preclude study entry - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics Chemotherapy: - See Disease Characteristics Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified


NCT ID:

NCT00006225


Primary Contact:

Study Chair
Jane N. Winter, MD
Robert H. Lurie Cancer Center


Backup Contact:

N/A


Location Contact:

Chicago, Illinois 60611
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 12, 2017

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