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
18 Years
65 Years
Both
Breast Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Compare Effectiveness of Chemotherapy + Filgrastim to Filgrastim Alone
Outcome Time Frame:
90 Days Post Transplant
Safety Issue:
No
Principal Investigator
James Gajewski, MD
Investigator Role:
Study Chair
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Federal Government
Study ID:
DM95-047
NCT ID:
NCT00002836
Start Date:
May 1995
Completion Date:
March 2006
Related Keywords:
- Breast Cancer
- recurrent breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
