Myeloablative Chemotherapy With Bone Marrow Rescue For Rare Poor-Prognosis Cancers
filgrastim
+ carboplatin
+ thiotepa
Urogenital Diseases+73
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
Study start date: October 1, 1992
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Until 21 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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 Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Memorial Sloan-Kettering Cancer Center
New York, United StatesOpen Memorial Sloan-Kettering Cancer Center in Google Maps