Sequential High-Dose Chemotherapy and Stem Cell Transplantation in Treating Patients With Chemotherapy-Sensitive Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00002680|
Recruitment Status : Completed
First Posted : April 29, 2004
Last Update Posted : July 24, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of sequential high-dose chemotherapy followed by peripheral stem cell transplantation in treating patients with metastatic breast cancer that is responding to chemotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: filgrastim Drug: cyclophosphamide Drug: megestrol acetate Drug: melphalan Drug: tamoxifen citrate Drug: thiotepa Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy||Phase 2|
OBJECTIVES: I. Determine the feasibility and efficacy of sequential high-dose cyclophosphamide, melphalan, and thiotepa plus autologous peripheral blood stem cell rescue in patients with metastatic breast cancer with ongoing objective response to prior induction chemotherapy.
OUTLINE: Patients receive sequential therapy beginning with regimen A. Regimen A: Patients receive cyclophosphamide IV over 1 hour every 6 hours or more for 4 doses within 36 hours. Patients receive filgrastim (G-CSF) subcutaneously (SC) daily beginning 2 days after completion of cyclophosphamide and continuing until autologous peripheral blood stem cells (PBSC) are harvested. Regimen B: Beginning at least 3 weeks after initiation of regimen A, patients receive melphalan IV on days 1 and 2. Beginning on day 4, a portion of the PBSC are reinfused. Patients receive G-CSF SC daily beginning on day 4 and continuing until at least day 10. Regimen C: Beginning at least 3 weeks after initiation of regimen B, patients receive thiotepa IV over 2 hours on days 1 and 2. Beginning on day 5, the remaining PBSC are reinfused. Patients receive G-CSF SC daily beginning on day 5 and continuing until blood counts recover. During regimens A, B, and C, G-CSF must be discontinued at least 2 days before administration of any chemotherapy. Regimen D: After recovery from chemotherapy, patients with hormone receptor-positive tumors and no prior refractoriness to hormonal therapies receive oral tamoxifen daily, while patients with prior failure on tamoxifen receive oral megestrol 4 times daily. Patients undergo irradiation to sites of prior cutaneous, nodal, bone, or soft tissue bulk disease and resection of residual lesions. Patients are followed weekly for 1 month, biweekly for 2 months, monthly for 5 months, and then bimonthly for 1 year.
PROJECTED ACCRUAL: A minimum of 30 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Official Title:||Phase II Trial of Sequential High-Dose Alkylating Agents in Metastatic Breast Cancer|
|Study Start Date :||February 1994|
|Actual Primary Completion Date :||December 2000|
|Actual Study Completion Date :||December 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002680
|United States, Connecticut|
|Yale Comprehensive Cancer Center|
|New Haven, Connecticut, United States, 06520-8028|
|Study Chair:||Michael DiGiovanna, MD||Yale University|