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Sponsored by: |
Barbara Ann Karmanos Cancer Institute |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00020722 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation plus biological therapy may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: This phase II trial is studying how well chemotherapy followed by peripheral stem cell transplantation plus biological therapy works in treating women with stage IV breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Biological: therapeutic autologous lymphocytes Drug: ICE regimen Drug: carboplatin Drug: cyclophosphamide Drug: etoposide Drug: high-dose chemotherapy Drug: ifosfamide Drug: thiotepa Procedure: leukapheresis Procedure: peripheral blood stem cell transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Treatment of Stage IV Breast Cancer With Activated T Cells After Peripheral Blood Stem Cell Transplant (Pilot Phase II) |
Estimated Enrollment: | 32 |
Study Start Date: | January 2000 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients are stratified according to tumor classification (chemosensitive vs chemoresistant).
Patients receive filgrastim (G-CSF) subcutaneously (SC) daily for 4 days followed by peripheral blood mononuclear cell (PBMC) collection for PBSCT and generation of activated T cells (ATC). The PBMC are treated ex vivo with monoclonal antibody OKT3 to form ATC. The ATC are expanded for 12-14 days in interleukin-2 (IL-2).
Patients then receive high-dose chemotherapy. Patients with chemosensitive disease receive cyclophosphamide IV over 1 hour, thiotepa IV over 1 hour, and carboplatin IV over 1 hour on days -4, -3, and -2. Patients with chemoresistant disease receive ifosfamide IV over 1 hour, etoposide IV twice daily, and carboplatin IV over 1 hour on days -8 to -3. Patients undergo autologous PBSC transplantation on day 0 or on both day 0 and day
1.
Patients then receive ATC IV over 15-20 minutes three times per week starting approximately on day +1 for three weeks and then once weekly for at least 6 doses.
After completion of study therapy, patients are followed periodically for up to 2 years after PBSC.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Women with histologically documented metastatic carcinoma of the breast
Measurable or evaluable recurrent metastatic disease (stage IV) documented by radiograph, CT scan, nuclear medicine scan, or physical exam
No clinical evidence of active brain metastases
Hormone receptor status:
PATIENT CHARACTERISTICS:
Systolic BP < 130 mm Hg and diastolic BP < 80 mm Hg
PRIOR CONCURRENT THERAPY:
No concurrent hormonal therapy for breast cancer
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | Recruiting |
Detroit, Michigan, United States, 48201-1379 | |
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute 313-576-9363 | |
Sinai-Grace Hospital | Recruiting |
Detroit, Michigan, United States, 48235 | |
Contact: Lawrence Lum 313-576-8326 |
Study Chair: | Lawrence G. Lum, MD, DSc | Barbara Ann Karmanos Cancer Institute |
Responsible Party: | Barbara Ann Karmanos Cancer Institute ( Lawrence G. Lum ) |
Study ID Numbers: | CDR0000068707, WSU-2007-033, RWMC-0634246 |
Study First Received: | July 11, 2001 |
Last Updated: | March 31, 2009 |
ClinicalTrials.gov Identifier: | NCT00020722 History of Changes |
Health Authority: | Unspecified |
stage IV breast cancer recurrent breast cancer |
Skin Diseases Immunologic Factors Breast Neoplasms Cyclophosphamide Carboplatin Etoposide phosphate Immunosuppressive Agents Recurrence |
Thiotepa Ifosfamide Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Etoposide Breast Diseases Isophosphamide mustard |
Molecular Mechanisms of Pharmacological Action Skin Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Cyclophosphamide Carboplatin Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Ifosfamide Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |