Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Rare Cancer
NCT ID: NCT00002515
Last Updated: 2013-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
1992-10-31
2005-04-30
Brief Summary
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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
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* 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.
Conditions
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Study Design
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TREATMENT
Interventions
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filgrastim
carboplatin
thiotepa
topotecan hydrochloride
autologous bone marrow transplantation
bone marrow ablation with stem cell support
in vitro-treated bone marrow transplantation
Eligibility Criteria
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Inclusion Criteria
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
21 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Principal Investigators
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Brian H. Kushner, MD
Role: STUDY_CHAIR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Countries
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Other Identifiers
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CDR0000078115
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-V93-0214
Identifier Type: -
Identifier Source: secondary_id
92-148
Identifier Type: -
Identifier Source: org_study_id
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