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Peripheral Stem Cell Transplantation Protocol for Patients With Previously Treated Advanced Breast Cancer - A Phase II Pilot Study

Phase 2
65 Years
Not Enrolling
Breast Cancer

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Trial Information

Peripheral Stem Cell Transplantation Protocol for Patients With Previously Treated Advanced Breast Cancer - A Phase II Pilot Study

OBJECTIVES: I. Assess the antitumor response, survival, and disease free survival following
high dose carboplatin, ifosfamide, and thiotepa with autologous peripheral blood stem cell
(PBSC) support and consolidation radiotherapy to sites of pretreatment bulk disease in
patients with previously treated advanced breast cancer. II. Assess the toxicity of high
dose chemotherapy in these patients. III. Compare the effectiveness of PBSC mobilization
with high dose cyclophosphamide and filgrastim (G-CSF) vs G-CSF alone in this patient

OUTLINE: Patients are assigned to 1 of 2 peripheral blood stem cell (PBSC) mobilization
groups at the discretion of the attending physician: Group 1: Patients receive high dose
cyclophosphamide IV over 6 hours and filgrastim (G-CSF) subcutaneously (SQ) daily beginning
24 hours after completion of cyclophosphamide and continuing until 3 days after blood counts
have recovered and until PBSC are harvested. Group 2: Patients receive G-CSF SQ daily alone
until PBSC are harvested. Both groups: PBSC are harvested on days 15-19 after
cyclophosphamide infusion or when blood counts recover. Patients receive high dose
carboplatin IV continuously, ifosfamide IV over 4 hours, and thiotepa IV over 1 hour on days
-5 to -3. PBSC are reinfused beginning 48 hours after completion of combination
chemotherapy. Patients receive G-CSF SQ beginning on day 0 and continuing until 3 days after
blood counts have recovered. Sites of pretransplantation metastases greater than 3 cm are
irradiated beginning after transplantation and after blood counts recover. Patients are
followed every month for 1 year.

PROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven previously treated stage III or IV breast
cancer No CNS disease Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: Physiologic 65 and under Menopausal status: Not specified
Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Not
specified Hepatic: Hepatic function normal unless due to liver metastases Bilirubin less
than 1.5 times normal SGOT or SGPT less than 1.5 times normal Alkaline phosphatase less
than 1.5 times normal If hepatitis C antibody positive, then liver function must be normal
OR liver dysfunction must be due to metastatic disease and not chronic hepatitis Renal:
Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 50 mL/min
Cardiovascular: LVEF normal No myocardial infarction within past 6 months No significant
arrhythmia requiring medications No history of congestive heart failure Pulmonary: DLCO at
least 50% predicted FEV1 and/or FVC at least 75% predicted No serious nonneoplastic
pulmonary disease (severe chronic obstructive lung disease) that would preclude study
therapy Other: Not pregnant Negative pregnancy test HIV negative Hepatitis B and C surface
antigen negative No active serious medical condition that would preclude study therapy

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Jane N. Winter, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center


United States: Federal Government

Study ID:

NU 92B3T



Start Date:

October 1999

Completion Date:

October 2003

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • stage IIIA breast cancer
  • recurrent breast cancer
  • stage IIIB breast cancer
  • Breast Neoplasms



Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611