Diseases

Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Rare Cancer

Descriptive Information
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.
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 Phase	Phase 2
Study Type ^†	Interventional
Study Design ^†	Primary Purpose: Treatment
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	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
Intervention ^†	Biologicalfilgrastim
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status ^†	Biological
Estimated Enrollment ^†
Start Date ^†	October 1992
Completion Date
Primary Completion Date
Eligibility 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
Gender	Both
Ages	N/A - 21 Years
Accepts Healthy Volunteers	No
Contacts ^††	, , , ,
Location Countries ^†	United States,
Administrative Information
NCT ID ^†	NCT00002515
Organization ID	CDR0000078115
Secondary IDs ^††	MSKCC-92148
Responsible Party	,
Study Sponsor ^†	Memorial Sloan-Kettering Cancer Center
Collaborators ^††
Investigators ^†	Study Chair: Brian H. Kushner, MD, Memorial Sloan-Kettering Cancer Center
Information Provided By	National Cancer Institute (NCI)
Verification Date	May 2005
First Received Date ^†	November 1, 1999
Last Updated Date	December 3, 2011

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.