Peripheral Stem Cell Transplantation With or Without Stromagen Following Chemotherapy in Treating Women With Metastatic Breast Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells. It is not yet known whether Stromagen improves the success of stem cell transplantation in women with breast cancer.
PURPOSE: Randomized phase I/II trial to study the effectiveness of Stromagen during stem cell transplantation following chemotherapy in treating women with metastatic breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: filgrastim Drug: carboplatin Drug: cyclophosphamide Drug: paclitaxel Drug: thiotepa Procedure: in vitro-treated bone marrow transplantation Procedure: in vitro-treated peripheral blood stem cell transplantation |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 30 |
| Study Start Date: | September 1998 |
| Study Completion Date: | December 2000 |
| Primary Completion Date: | February 2000 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201 | |
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| United States, Ohio | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Study Chair: | Philip L. McCarthy, MD | Roswell Park Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Phillip McCarthy, MD, Roswell Park Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00003877 History of Changes |
| Other Study ID Numbers: | CDR0000067043, P30CA016056, RPCI-DS-9828, CWRU-OSIR-1198, OSIRIS-101, NCI-G99-1516 |
| Study First Received: | November 1, 1999 |
| Last Updated: | March 3, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Roswell Park Cancer Institute:
|
stage IV breast cancer recurrent breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Thiotepa Carboplatin Paclitaxel Lenograstim Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on June 17, 2013