Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Brain Tumor

NCT00003273 | Withdrawn Phase 2

• 3 other identifiers: CDR0000066174NYU-P9712NCI-V98-1400
• Study Type: interventional
• Target: N/A
• Locations: 3 countries
• Sites: 19

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of different regimens of combination chemotherapy followed by peripheral stem cell transplantation in treating children who have newly diagnosed brain tumor.

Conditions

Brain and Central Nervous System Tumors; Neuroblastoma; Retinoblastoma; Sarcoma

Keywords

childhood infratentorial ependymoma; childhood supratentorial ependymoma; localized resectable neuroblastoma; regional neuroblastoma; disseminated neuroblastoma; stage 4S neuroblastoma; extraocular retinoblastoma; childhood choroid plexus tumor; localized unresectable neuroblastoma; previously untreated childhood rhabdomyosarcoma; untreated childhood supratentorial primitive neuroectodermal tumor; untreated childhood medulloblastoma; newly diagnosed childhood ependymoma

Interventions

filgrastim BIOLOGICAL

carboplatin DRUG

cisplatin DRUG

cyclophosphamide DRUG

etoposide DRUG

leucovorin calcium DRUG

methotrexate DRUG

temozolomide DRUG

thiotepa DRUG

vincristine sulfate DRUG

autologous bone marrow transplantation PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

DISEASE CHARACTERISTICS: * Histologically confirmed malignant, newly diagnosed brain tumor Regimen A: * Posterior fossa medulloblastoma/primitive neuroectodermal tumor (PNET): * All stages, under 3 years at diagnosis OR * High stage (local residual tumor postoperatively and/or neuraxis or extraneural dissemination), 3-10 years at diagnosis * Supratentorial PNET, pineoblastoma, cerebral neuroblastoma, ependymoblastoma, medulloepithelioma, medullomyoblastoma: * All stages, under 10 years at diagnosis * Brainstem PNET: * All stages, irrespective of extent of resection, under 10 years at diagnosis * Ependymoma or anaplastic ependymoma: * All stages, any location (except primary spinal cord ependymoma), under 3 years at diagnosis OR * Local residual tumor postoperatively and/or neuraxis dissemination, any location, 3-10 years at diagnosis * Supratentorial ependymoma: * All stages, irrespective of extent of resection, under 10 years at diagnosis, excluding gross totally resected (confirmed by postoperative MRI) low grade ependymoma not invading the ventricular system * Metastatic retinoblastoma: * Previously untreated (except for cryosurgery or laser surgery), under 10 years at presentation of metastatic disease * Primary atypical teratoid/rhabdoid tumors of the CNS: * Under 10 years at diagnosis * Choroid plexus carcinoma: * Incompletely resected, all sites, under 10 years at diagnosis Regimen C: * Anaplastic astrocytoma, glioblastoma multiforme, anaplastic oligodendroglioma, anaplastic ganglioglioma, other anaplastic mixed gliomas: * Under 10 years at diagnosis * Diffuse intrinsic pontine tumors: * Unbiopsied, under 10 years at diagnosis The following diagnoses are not eligible: * Myxopapillary ependymoma of the spinal cord, low grade brainstem astrocytoma, primary CNS lymphoma or solid leukemic lesion (i.e., chloroma, granulocytic sarcoma), or primary CNS germ cell tumor PATIENT CHARACTERISTICS: Age: * Under 10 at diagnosis Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin less than 1.5 mg/dL * SGPT less than 2.5 times upper limit of normal Renal: * Creatinine clearance greater than 60 mL/min PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Prior corticosteroids allowed * No concurrent corticosteroids for the sole purpose of antiemesis Radiotherapy: * No prior radiotherapy Surgery: * See Disease Characteristics * Recovered from prior surgery

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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (19)

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813, United States

Location

Maine Children's Cancer Program

Scarborough, Maine, 04074-9308, United States

Location

Spectrum Health and DeVos Children's Hospital

Grand Rapids, Michigan, 49503, United States

Location

Children's Hospital of Omaha

Omaha, Nebraska, 68114, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Beth Israel Hospital North

New York, New York, 10128, United States

Location

State University of New York Health Sciences Center - Stony Brook

Stony Brook, New York, 11790-7775, United States

Location

State University of New York - Upstate Medical University

Syracuse, New York, 13210, United States

Location

Albert Einstein Clinical Cancer Center

The Bronx, New York, 10461, United States

Location

St. Vincent Mercy Medical Center

Toledo, Ohio, 43608, United States

Location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Children's Hospital

Buenos Aires, Buenos Aires, 1425, Argentina

Location

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Neuroblastoma; Retinoblastoma; Sarcoma; Choroid Plexus Neoplasms

Interventions

Filgrastim; Carboplatin; Cisplatin; Cyclophosphamide; Etoposide; Leucovorin; Methotrexate; Temozolomide; Thiotepa; Vincristine; Peripheral Blood Stem Cell Transplantation; Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Retinal Neoplasms; Eye Neoplasms; Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases; Neoplasms, Connective and Soft Tissue; Cerebral Ventricle Neoplasms; Brain Neoplasms; Brain Diseases; Central Nervous System Diseases

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; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Aminopterin; Dacarbazine; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Triethylenephosphoramide; Aziridines; Azirines; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Jonathan L. Finlay, MB, ChB

  NYU Langone Health

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: November 1, 1997
• Last Updated: December 3, 2015

Record last verified: 2015-11

Locations

CA (1); US (17); AR (1)