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| Descriptive Information Fields | |||||
| Brief Title † | Chemotherapy Followed by Peripheral Stem Cell Transplantation Plus Biological Therapy in Treating Patients With Stage IIIB or Stage IV Breast Cancer or Other Solid Tumors | ||||
| Official Title † | Treatment of Stage IIIB or IV Breast Cancer or Other Solid Tumors With Activated T Cells, Low Dose IL-2, and GM-CSF After Peripheral Blood Stem Cell Transplant (Pilot Phase II) | ||||
| Brief Summary | 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 the side effects, best way to give, and best dose of chemotherapy followed by peripheral stem cell transplantation plus biological therapy and to see how well it works in treating patients with stage IIIB or stage IV breast cancer or other solid tumors. |
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| Detailed Description | OBJECTIVES:
OUTLINE: Patients are stratified according to disease (stage IIIB breast vs stage IV breast vs solid tumors). Patients with breast cancer are also stratified according to tumor classification (chemosensitive vs chemoresistant). Patients receive filgrastim (G-CSF) subcutaneously (SC) daily for 5 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, thiotepa IV, and carboplatin IV on days -6, -5, and -4. Patients with chemoresistant disease receive ifosfamide IV, carboplatin IV, and etoposide IV on days -8 to -3. Patients undergo autologous PBSC transplantation on day 0. Patients then receive ATC IV over 15-20 minutes three times per week starting day +4 for three weeks and then once weekly for at least 6 doses. Patients also receive low-dose IL-2 SC daily and sargramostim (GM-CSF) SC twice weekly on days 4 until last infusion of ATC. Patients are followed at 3 and 6 months post-transplantation and then annually thereafter. PROJECTED ACCRUAL: A total of 60 patients (10-15 with solid tumors) will be accrued. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Open Label | ||||
| Primary Outcome Measure † | Disease-free survival [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Overall survival [ Designated as safety issue: No ] | ||||
| Condition † | Breast Cancer Extragonadal Germ Cell Tumor Gestational Trophoblastic Tumor Kidney Cancer Lung Cancer Neuroblastoma Ovarian Cancer Sarcoma Testicular Germ Cell Tumor Unspecified Adult Solid Tumor, Protocol Specific |
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| Intervention † | Drug: aldesleukin Drug: busulfan Drug: carboplatin Drug: cyclophosphamide Drug: etoposide Drug: filgrastim Drug: ifosfamide Drug: paclitaxel Drug: sargramostim Drug: therapeutic autologous lymphocytes Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 60 | ||||
| Start Date † | January 2000 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00020722 | ||||
| Organization ID | CDR0000068707 | ||||
| Secondary IDs †† | WSU-2007-033, RWMC-0634246 | ||||
| Study Sponsor † | Barbara Ann Karmanos Cancer Institute | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | August 2008 | ||||
| First Received Date † | July 11, 2001 | ||||
| Last Updated Date | August 26, 2008 | ||||