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| Descriptive Information Fields | |||||
| Brief Title † | Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Rare Cancer | ||||
| Official Title † | Myeloablative Chemotherapy With Bone Marrow Rescue For Rare Poor-Prognosis Cancers | ||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bone marrow transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with thiotepa, carboplatin, and topotecan followed by bone marrow transplantation in treating patients who have metastatic or progressive rare cancer. |
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| Detailed Description | OBJECTIVES:
OUTLINE: Autologous bone marrow or peripheral blood stem cells (PBSC) are harvested. Patients receive high-dose thiotepa IV over 3 hours on days -8 to -6, carboplatin IV over 4 hours on days -5 to -3, and topotecan IV over 30 minutes on days -8 to -4. Autologous bone marrow or PBSC are reinfused on day 0. Patients receive filgrastim (G-CSF) IV twice daily beginning on day 1. Patients are followed for 1 year. PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study within 5 years. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Bone Marrow Ablation Childhood Germ Cell Tumor Extragonadal Germ Cell Tumor Head and Neck Cancer Kidney Cancer Liver Cancer Lymphoma Neuroblastoma Ovarian Cancer Retinoblastoma Sarcoma Testicular Germ Cell Tumor |
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| Intervention † | Drug: carboplatin Drug: filgrastim Drug: thiotepa Drug: topotecan hydrochloride Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support Procedure: in vitro-treated bone marrow 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 † | Completed | ||||
| Enrollment † | |||||
| Start Date † | October 1992 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Gender | Both | ||||
| Ages | up to 21 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00002515 | ||||
| Organization ID | CDR0000078115 | ||||
| Secondary IDs †† | MSKCC-92148, NCI-V93-0214 | ||||
| Study Sponsor † | Memorial Sloan-Kettering Cancer Center | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | May 2005 | ||||
| First Received Date † | November 1, 1999 | ||||
| Last Updated Date | July 23, 2008 | ||||