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

NCT00002515 | Completed Phase 2

• 3 other identifiers: 92-148CDR0000078115NCI-V93-0214
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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 childhood soft tissue sarcoma; 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

Interventions

filgrastim BIOLOGICAL

carboplatin DRUG

thiotepa DRUG

topotecan hydrochloride DRUG

autologous bone marrow transplantation PROCEDURE

bone marrow ablation with stem cell support PROCEDURE

in vitro-treated bone marrow transplantation PROCEDURE

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Kidney Neoplasms; Liver Neoplasms; Lymphoma; Neuroblastoma; Ovarian Neoplasms; Retinoblastoma; Sarcoma; Testicular Germ Cell Tumor; Chondrosarcoma; Wilms Tumor; Osteosarcoma; Testicular Neoplasms; Fibrosarcoma; Desmoplastic Small Round Cell Tumor; Burkitt Lymphoma; Dendritic Cell Sarcoma, Interdigitating; Neuroectodermal Tumors, Primitive, Peripheral

Interventions

Filgrastim; Carboplatin; Thiotepa; Topotecan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Retinal Neoplasms; Eye Neoplasms; Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms, Connective Tissue; Neoplasms, Complex and Mixed; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neoplasms, Bone Tissue; Genital Neoplasms, Male; Genital Diseases, Male; Testicular Diseases; Neoplasms, Fibrous Tissue; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Histiocytic Disorders, Malignant; Histiocytosis

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Coordination Complexes; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids

Study Officials

• Brian H. Kushner, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: October 1, 1992
• Primary Completion: April 1, 2005
• Study Completion: April 1, 2005
• Last Updated: June 24, 2013

Record last verified: 2013-06

Locations

US (1)