Radiation Therapy, Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Primitive Neuroectodermal Tumors

NCT00003846 | Completed Phase 2 DMC

• 4 other identifiers: 99702COG-99702CCG-99702CDR0000067006
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 13

Brief Summary

RATIONALE: Radiation therapy uses x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of radiation therapy and chemotherapy and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of radiation therapy, chemotherapy and peripheral stem cell transplantation in treating patients with primitive neuroectodermal tumors.

Conditions

Brain and Central Nervous System Tumors; Neuroblastoma

Keywords

regional neuroblastoma; disseminated neuroblastoma; stage 4S neuroblastoma; untreated childhood supratentorial primitive neuroectodermal tumor; untreated childhood medulloblastoma; newly diagnosed childhood ependymoma

Outcome Measures

Primary Outcomes (1)

• Event Free Survival

Study Arms (1)

Treatment

EXPERIMENTAL

See detailed description.

Biological: filgrastim; Drug: carboplatin; Drug: cyclophosphamide; Drug: thiotepa; Drug: vincristine sulfate; Procedure: bone marrow ablation with stem cell support; Procedure: peripheral blood stem cell transplantation; Radiation: radiation therapy

Interventions

filgrastim BIOLOGICAL

Also known as: Neupogen®, G-CSF, NSC#614629

Treatment

carboplatin DRUG

Also known as: Paraplatin®, CBDCA, NSC#241240

Treatment

cyclophosphamide DRUG

Also known as: Cytoxan®, Neosar®, Procytox®, CPM

Treatment

thiotepa DRUG

Also known as: TRIETHYLENETHIOPHOSPHORAMIDE, THIOPLEX®, TEPA, NSC# 6396

Treatment

vincristine sulfate DRUG

Also known as: Oncovin®, Vincasar®, leucocristine, VCR, NSC# 67574

Treatment

bone marrow ablation with stem cell support PROCEDURE

Treatment

peripheral blood stem cell transplantation PROCEDURE

Treatment

radiation therapy RADIATION

Treatment

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically proven primitive neuroectodermal tumor (PNET) of one of the following types: * Atypical teratoid/rhabdoid tumor * Medulloblastoma * Desmoplastic medulloblastoma * Ependymoblastoma * Medullomyoblastoma * Spongioblastoma * Spongioblastoma polare * Primitive polar spongioblastoma * Medulloepithelioma * Neuroblastoma * Pineoblastoma * Posterior fossa PNET must be M1-3 or M0 with greater than 1.5 cm2 residual disease * Non posterior fossa PNET and other types must be M0-3 * If M3, must show clear evidence of tumor on MRI * No marrow involvement or other extraneural metastases * No M4 disease * No cord compression requiring emergency radiotherapy PATIENT CHARACTERISTICS: Age: * 3 to 21 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,000/mm\^3 * Platelet count at least 150,000/mm\^3 (no platelet transfusions) * Hemoglobin at least 10 g/dL (red blood cell transfusions allowed) Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * AST or ALT less than 2.5 times ULN Renal: * Creatinine clearance or glomerular filtration rate at least 70 mL/min Cardiovascular: * Shortening fraction greater than 27% by echocardiogram OR * Ejection fraction greater than 47% by MUGA Pulmonary: * FEV\_1/FVC greater than 60% except for children who: * Are uncooperative * Have no dyspnea at rest * Have no exercise intolerance * Have pulse oximetry greater than 94% on room air Other: * Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Steroids for increased intracranial pressure allowed Radiotherapy: * See Disease Characteristics * No prior urgent radiotherapy Surgery: * Not specified Other: * No prior therapy for tumor

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

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (13)

Children's Hospital Los Angeles

Los Angeles, California, 90027-0700, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Children's Hospital of Orange County

Orange, California, 92668, United States

Location

Children's Hospital of Denver

Denver, Colorado, 80218, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, 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

Children's Hospital Medical Center - Cincinnati

Cincinnati, Ohio, 45229-3039, United States

Location

Children's Hospital of Columbus

Columbus, Ohio, 43205-2696, United States

Location

Oregon Cancer Center at Oregon Health Sciences University

Portland, Oregon, 97201-3098, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Neuroblastoma

Interventions

Filgrastim; Granulocyte Colony-Stimulating Factor; Carboplatin; Cyclophosphamide; Thiotepa; Triethylenephosphoramide; 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

Intervention Hierarchy (Ancestors)

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; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 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

• H. Stacy Nicholson, MD, MPH

  OHSU Knight Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 25, 2004
• Study Start: July 1, 1999
• Primary Completion: October 1, 2004
• Study Completion: March 1, 2007
• Last Updated: July 28, 2014

Record last verified: 2014-07

Locations

US (13)