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A Phase I/II Study in Metastatic Breast Cancer Patients Infused With Stromagen and Isolated, Mobilized, Autologous Peripheral Blood CD34+ Progenitor Cells After High-Dose Chemotherapy


Phase 1/Phase 2
18 Years
64 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Phase I/II Study in Metastatic Breast Cancer Patients Infused With Stromagen and Isolated, Mobilized, Autologous Peripheral Blood CD34+ Progenitor Cells After High-Dose Chemotherapy


OBJECTIVES: I. Determine the safety of expanded mesenchymal stem cells (Stromagen) infusion
and autologous CD34+ peripheral blood stem cells transplantation after high dose
chemotherapy in women with metastatic breast cancer. II. Compare the time to neutrophil and
platelet engraftment in patients receiving different doses of Stromagen. III. Evaluate the
immune reconstitution of these patients after this therapy.

OUTLINE: This is a randomized, placebo controlled, blinded study. Patients are randomly
assigned to one of three treatment arms. All patients undergo mobilization of peripheral
blood stem cells (PBSC) using cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours
on day 1, and filgrastim (G-CSF) subcutaneously beginning on day 4 and continuing until
completion of leukapheresis. PBSC and bone marrow cells are collected and CD34 positive
cells are then selected. About 4 weeks later, patients receive high dose chemotherapy.
Cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24
hours are administered on days -7 to -4. Patients then receive placebo or one of two doses
of expanded mesenchymal stem cells (Stromagen) IV on day -1 and CD34+ selected PBSC IV over
2 hours on day 0. Patients are followed at 6 weeks and 12 weeks, than at 1 year.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven metastatic breast cancer involving at least
1 bone site Completed induction chemotherapy No active CNS disease Hormone receptor
status: Estrogen receptor and progesterone receptor negative OR Hormone refractory disease

PATIENT CHARACTERISTICS: Age: 18 to 64 Sex: Female Menopausal status: Not specified
Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC
greater than 1000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Hepatitis B surface
antigen negative Hepatitis C negative No cirrhosis Renal: Creatinine less than 2.0 mg/dL
OR Creatinine clearance greater than 50 mL/min Cardiovascular: Cardiac ejection fraction
greater than 50% by MUGA Pulmonary: DLCO greater than 50% Other: Not pregnant Fertile
patients must use effective contraception No active infection No active alcohol or
substance abuse within 6 months At least 1 year since clinically significant CNS disease
or seizures HIV negative No other medical condition that would preclude evaluation of the
patient

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: See Disease Characteristics Radiotherapy: At least 3
years since prior radiotherapy, except local adjuvant therapy Surgery: Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Philip L. McCarthy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000067043

NCT ID:

NCT00003877

Start Date:

September 1998

Completion Date:

December 2000

Related Keywords:

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Ireland Cancer CenterCleveland, Ohio  44106-5065