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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Myeloablative Chemotherapy With Bone Marrow Rescue For Rare Poor-Prognosis Cancers

Conditions
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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 / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: filgrastim|nan|
|Drug: carboplatin|nan|
|Drug: thiotepa|nan|
|Drug: topotecan hydrochloride|nan|
|Procedure: autologous bone marrow transplantation|nan|
|Procedure: bone marrow ablation with stem cell support|nan|
|Procedure: in vitro-treated bone marrow transplantation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent childhood soft tissue sarcoma, 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 ovarian germ cell tumor, childhood fibrosarcoma, extragonadal germ cell tumor, 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