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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00003273
First received: November 1, 1999
Last updated: June 3, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Neuroblastoma
Retinoblastoma
Sarcoma
Biological: filgrastim
Drug: carboplatin
Drug: cisplatin
Drug: cyclophosphamide
Drug: etoposide
Drug: leucovorin calcium
Drug: methotrexate
Drug: temozolomide
Drug: thiotepa
Drug: vincristine sulfate
Procedure: autologous bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Dose Intensive Chemotherapy for Children Less Than Ten Years of Age Newly-Diagnosed With Malignant Brain Tumors: A Pilot Study of Two Alternative Intensive Induction Chemotherapy Regimens, Followed by Consolidation With Myeloablative Chemotherapy (Thiotepa, Etoposide and Carboplatin) and Autologous Stem Cell Rescue

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Estimated Enrollment: 96
Study Start Date: November 1997
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003273

Locations
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Maine
Maine Children's Cancer Program
Scarborough, Maine, United States, 04074-9308
United States, Michigan
Spectrum Health and DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
United States, Nebraska
Children's Hospital of Omaha
Omaha, Nebraska, United States, 68114
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Albert Einstein Clinical Cancer Center
Bronx, New York, United States, 10461
Winthrop University Hospital
Mineola, New York, United States, 11501
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Beth Israel Hospital North
New York, New York, United States, 10128
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States, 11790-7775
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
United States, Ohio
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
United States, Pennsylvania
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Argentina
Children's Hospital
Buenos Aires, Argentina, 1425
Canada, British Columbia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
New York University School of Medicine
Investigators
Study Chair: Jonathan L. Finlay, MB, ChB New York University School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00003273     History of Changes
Other Study ID Numbers: CDR0000066174, NYU-P9712, NCI-V98-1400
Study First Received: November 1, 1999
Last Updated: June 3, 2011
Health Authority: United States: Federal Government

Keywords provided by New York University School of Medicine:
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

Additional relevant MeSH terms:
Central Nervous System Neoplasms
Neoplasms
Nervous System Neoplasms
Neuroblastoma
Retinoblastoma
Eye Diseases
Eye Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Nervous System Diseases
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Retinal Diseases
Retinal Neoplasms
Carboplatin
Cyclophosphamide
Etoposide
Levoleucovorin
Methotrexate
Temozolomide
Thiotepa
Vincristine
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents

ClinicalTrials.gov processed this record on October 21, 2014