- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002515
Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Rare Cancer
Myeloablative Chemotherapy With Bone Marrow Rescue For Rare Poor-Prognosis Cancers
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.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- Improve the long term disease-free survival of patients with rare cancers at high risk for lethal relapse by using myeloablative chemotherapy with thiotepa, carboplatin, and topotecan followed by autologous bone marrow or peripheral blood stem cell rescue.
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy of one of the following types:
- Wilms' tumor
- Liver cancer
- Desmoplastic or other small round cell tumor
- Nasopharyngeal carcinoma
- Fibrosarcoma
- Disease that has metastasized and has a cure rate of no greater than 25% with conventional treatment or disease that has progressed after prior chemotherapy, was not then surgically resectable, and has a salvage rate with nonmyeloablative therapies of no greater than 25% required
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:
- 2 courses of high-dose cyclophosphamide (as per protocol MSKCC-90062)
- 2 courses of high-dose ifosfamide/etoposide (as in the poor-risk sarcoma protocol MSKCC-90071A)
- 1 course of high-dose cyclophosphamide plus 1 course of high-dose ifosfamide/etoposide
Within 3 weeks of initiation of protocol therapy, patients must be:
- In CR or good PR OR
- Tumor considered "chemosensitive", i.e., a 50% or greater decrease in at least 1 measurable tumor parameter attributable to prior chemotherapy without evidence of progressive disease by any other parameter
- Ineligible for other IRB-approved myeloablative regimens
- No evidence of current bone marrow involvement on bone marrow aspiration (x4) and biopsy (x2)
PATIENT CHARACTERISTICS:
Age:
- 21 and under
Performance status:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT no greater than 1.5 times ULN
- Alkaline phosphatase no greater than 1.5 times ULN
- 5'-Nucleotidase no greater than 1.5 times ULN
Renal:
- Creatinine normal
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- CPK normal
- Echocardiogram (or RNCA) normal
- EKG normal
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage IV squamous cell carcinoma of the nasopharynx
- stage IV lymphoepithelioma of the nasopharynx
- recurrent squamous cell carcinoma of the nasopharynx
- recurrent lymphoepithelioma of the nasopharynx
- chondrosarcoma
- stage IV childhood small noncleaved cell lymphoma
- stage IV childhood large cell lymphoma
- recurrent childhood small noncleaved cell lymphoma
- recurrent childhood large cell lymphoma
- recurrent childhood rhabdomyosarcoma
- recurrent neuroblastoma
- stage IV childhood lymphoblastic lymphoma
- recurrent ovarian germ cell tumor
- stage IV ovarian germ cell tumor
- recurrent childhood lymphoblastic lymphoma
- recurrent malignant testicular germ cell tumor
- stage IV Wilms tumor
- recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
- recurrent osteosarcoma
- recurrent Wilms tumor and other childhood kidney tumors
- extragonadal germ cell tumor
- stage IV childhood liver cancer
- recurrent childhood liver cancer
- recurrent childhood soft tissue sarcoma
- childhood germ cell tumor
- alveolar childhood rhabdomyosarcoma
- recurrent retinoblastoma
- childhood desmoplastic small round cell tumor
- childhood fibrosarcoma
Additional Relevant MeSH Terms
- Digestive System Diseases
- Immune System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Eye Diseases
- Digestive System Neoplasms
- Retinal Diseases
- Liver Diseases
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Nerve Tissue
- Eye Diseases, Hereditary
- Neuroectodermal Tumors, Primitive
- Neuroectodermal Tumors, Primitive, Peripheral
- Eye Neoplasms
- Retinal Neoplasms
- Neoplasms
- Sarcoma
- Lymphoma
- Neoplasms, Germ Cell and Embryonal
- Liver Neoplasms
- Neuroblastoma
- Retinoblastoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Carboplatin
- Topotecan
- Thiotepa
Other Study ID Numbers
- 92-148
- CDR0000078115 (Registry Identifier: PDQ (Physician Data Query))
- NCI-V93-0214
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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