A Phase III Randomized Comparison of High Dose Chemotherapy G-CSF To G-CSF For Mobilization of Peripheral Blood Stem Cells For Autologous Transplantation For Patients With Responsive Metastatic Breast Cancer Or High Risk Stage II-III Patients
Filgrastim (G-CSF)
+ Carmustine
+ Cisplatin
Breast Diseases+3
+ Neoplasms
+ Neoplasms by Site
Treatment Study
Summary
Study start date: September 26, 1995
Actual date on which the first participant was enrolled.OBJECTIVES: I. Determine whether high dose chemotherapy in addition to growth factors increases the yield of filgrastim mobilized progenitor cells. II. Determine the kinetics of hematopoietic reconstitution following myeloablative therapy and mobilized blood stem cell transplantation. III. Determine whether the use of high dose chemotherapy in addition to growth factors for mobilization of stem cells reduces risk of relapse as measured by time to progression in responsive relapsed breast cancer patients receiving autologous peripheral blood stem cell or bone marrow transplants. IV. Determine the morbidity and cost differences of the use of high dose chemotherapy plus growth factors compared to growth factors alone for mobilization of peripheral blood progenitors and treatment of breast cancer with high dose chemotherapy. OUTLINE: Patients will be randomized into 2 groups. Group 1 patients undergo CVP chemotherapy treatment by vein (IV) on days 1-3, with cyclophosphamide (CTX), etoposide, and cisplatin. Filgrastim SC (subcutaneously) is given on day 4 every 12 hours until completion of apheresis. Group 2 patients only receive filgrastim SC given on day 1 every 12 hours until completion of apheresis. Stem cells are removed beginning on day 4 for a maximum of 6 days. Upon recovery of hematopoiesis patients then receive high IV doses of CBT chemotherapy with CTX, carmustine, and thiotepa for 3 days, followed 4 days later by autologous stem cell reinfusion. Beginning on day of reinfusion, filgrastim is given bid until WBC reaches a safe level. Patients are followed for 90 days posttransplant, and then followed indefinitely for antitumor response and time to progression. PROJECTED ACCRUAL: This study will include about 218 patients.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.184 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Female patients with Stage II, III or IV breast carcinoma in remission, and not eligible for protocols of higher priority (DM89-102) Stage II breast cancer must have spread to at least 10 axillary nodes; patients with fewer than 10 nodes must have extranodal extensions Patients with greater than 75% positive nodes for tumor are eligible No bone marrow involvement with tumor by standard histopathological exam of bilateral iliac marrow biopsies 2 weeks prior to study Prior normalization of markers needed in patients with elevated tumor markers (e.g., CEA) Metastatic disease patients must have documentation verifying at least 50% reduction of all sites of disease, except bone Stable bone metastases measured via bone scan are eligible Responsive disease but with large tumor burden should enter high risk BMT protocols (93-090) PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: Zubrod 0-1 Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Platelet count greater than 100,000/mm3 No hematopoietic growth factor treatments Hepatic: Bilirubin, SGOT, and SGPT less than 2 times normal Renal: Estimated creatinine clearance greater than 60 mL/min Cardiovascular: Normal ejection fraction Pulmonary: DLCO greater than 50% of predicted Other: Not HIV positive Not pregnant 2 weeks prior to study No comorbid condition placing patient at high risk for complications No prior active infections No history of untreated central nervous system (CNS) disease No allergic response to eggs or murine protein PRIOR CONCURRENT THERAPY: No concurrent involvement in any other clinical trial that effects engraftment Biologic therapy: No growth factors within 1 week Chemotherapy: No more than 2 chemotherapy regimens allowed after relapse for metastatic disease Chemotherapy responsive disease prior to study Stage II/III disease receiving neoadjuvant chemotherapy allowed with at least 4 positive nodes at mastectomy No partial response to chemotherapy less than 50% of any site except bone No prior chemotherapy treatment with carmustine Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Mastectomy allowed
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Texas - MD Anderson Cancer Center
Houston, United StatesOpen University of Texas - MD Anderson Cancer Center in Google Maps