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| Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002515 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Biological: filgrastim Drug: carboplatin 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 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Myeloablative Chemotherapy With Bone Marrow Rescue For Rare Poor-Prognosis Cancers |
| Study Start Date: | October 1992 |
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
Patients are followed for 1 year.
PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study within 5 years.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy of one of the following types:
Maximal benefit from conventional (nonmyeloablative) doses of combination chemotherapy required prior to entry, and it is recommended that patients have received a minimum of one of the following:
Within 3 weeks of initiation of protocol therapy, patients must be:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Brian H. Kushner, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Study ID Numbers: | CDR0000078115, MSKCC-92148, NCI-V93-0214 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002515 History of Changes |
| Health Authority: | United States: Federal Government |
|
chondrosarcoma recurrent childhood rhabdomyosarcoma stage IV childhood liver cancer recurrent neuroblastoma recurrent childhood liver cancer recurrent Wilms tumor and other childhood kidney tumors stage IV Wilms tumor recurrent retinoblastoma stage IV childhood lymphoblastic lymphoma recurrent childhood lymphoblastic lymphoma recurrent osteosarcoma stage IV ovarian germ cell tumor recurrent malignant testicular germ cell tumor childhood germ cell tumor alveolar childhood rhabdomyosarcoma |
recurrent childhood soft tissue sarcoma recurrent ovarian germ cell tumor childhood fibrosarcoma extragonadal germ cell tumor bone marrow ablation childhood desmoplastic small round cell tumor recurrent childhood small noncleaved cell lymphoma stage IV childhood small noncleaved cell lymphoma recurrent childhood large cell lymphoma stage IV childhood large cell lymphoma recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor stage IV lymphoepithelioma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the nasopharynx recurrent lymphoepithelioma of the nasopharynx |
|
Retinal Neoplasms Fibrosarcoma Liver Diseases Neuroectodermal Tumors, Primitive Urogenital Neoplasms Squamous Cell Carcinoma Retinoblastoma Urologic Neoplasms Neoplasms, Connective and Soft Tissue Wilms' Tumor Osteogenic Sarcoma Neuroepithelioma Ovarian Cancer Kidney Diseases Rhabdomyosarcoma |
Endocrine Gland Neoplasms Lymphoma, Large B-Cell, Diffuse Nasopharyngeal Carcinoma Digestive System Neoplasms Immunoproliferative Disorders Testicular Cancer Eye Neoplasms Genital Neoplasms, Female Endocrine System Diseases Carboplatin Testicular Neoplasms Ewing's Sarcoma Thiotepa Carcinoma Neuroectodermal Tumors |
|
Retinal Neoplasms Liver Diseases Neuroectodermal Tumors, Primitive Molecular Mechanisms of Pharmacological Action Urogenital Neoplasms Urologic Neoplasms Retinoblastoma Neoplasms, Connective and Soft Tissue Neoplasms by Site Therapeutic Uses Kidney Diseases Endocrine Gland Neoplasms Digestive System Neoplasms Immunoproliferative Disorders Immune System Diseases |
Eye Neoplasms Genital Neoplasms, Female Endocrine System Diseases Carboplatin Carcinoma Neuroectodermal Tumors Neoplasms Sarcoma Neoplasms, Neuroepithelial Topotecan Neoplasms, Glandular and Epithelial Gonadal Disorders Antineoplastic Agents Neoplasms, Nerve Tissue Ovarian Diseases |
