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Home > "P" Clinical Trials Conditions > Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer  Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer
Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer
For Condition: Breast Cancer,Male Breast Cancer,myelodysplastic and myeloproliferative diseases,Leukemia,plasma cell neoplasm,Lymphoma
Status: No longer recruiting
Sponsor(s): Robert H. Lurie Cancer Center ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry 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/mm3; Platelet count greater than 100,000/mm3 - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JaneWinter, Study Chair, Robert H. Lurie Cancer Center
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
United States
Additional Information:
Study ID Numbers: CDR0000068145; NCI-V00-1611,NU-97B2
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006225
Other Myelodysplastic And Myeloproliferative Diseases Studies:
1. Darbepoetin alfa Compared With Epoetin alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer
2. Epoetin alfa in Treating Anemia in Patients With Solid Tumors
3. Sirolimus in Preventing Graft-Versus-Host Disease in Patients With Hematologic Malignancies Who Are Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
4. T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Treated Donor T Cells After Immunoablative Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Hematologic Malignancies
5. Total-Body Irradiation With Or Without Fludarabine Followed By Allogeneic Hematopoietic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies
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Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer
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