NCT00025558

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining temozolomide, thiotepa, and carboplatin followed by peripheral stem cell transplantation or bone marrow transplantation in treating patients who have brain cancer.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 11, 2001

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Last Updated

March 28, 2011

Status Verified

March 1, 2011

Enrollment Period

6.6 years

First QC Date

October 11, 2001

Last Update Submit

March 25, 2011

Conditions

Brain and Central Nervous System Tumors

Keywords

childhood central nervous system germ cell tumorrecurrent adult brain tumoradult medulloblastomaadult glioblastomaadult anaplastic astrocytomaadult anaplastic oligodendrogliomaadult mixed gliomaadult central nervous system germ cell tumoradult pineoblastomarecurrent childhood supratentorial primitive neuroectodermal tumorrecurrent childhood medulloblastomarecurrent childhood ependymomaadult giant cell glioblastomaadult gliosarcomaadult anaplastic ependymomaadult supratentorial primitive neuroectodermal tumor (PNET)

Interventions

filgrastimBIOLOGICAL
carboplatinDRUG
temozolomideDRUG
thiotepaDRUG
autologous bone marrow transplantationPROCEDURE
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age1 Year - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * Diagnosis of one of the following malignant brain tumors: * Anaplastic astrocytoma * Glioblastoma multiforme * Anaplastic oligodendroglioma * Medulloblastoma * High-grade ependymoma * Germ cell tumors * Pineoblastoma * Other primitive neuroectodermal tumors * Recurrent disease or resistant to conventional therapy (e.g., surgery, radiotherapy, or standard chemotherapy) * No prior myeloablative doses of thiotepa OR * Newly diagnosed malignant glioma with minimal residual disease after prior radiotherapy * Minimal residual disease is defined as tumor with maximum diameter of less than 1.5 cm by MRI and no corticosteroid dependency PATIENT CHARACTERISTICS: Age: * Over 1 to under 50 Performance status: * Karnofsky 70-100% OR * Lansky 70-100% Life expectancy: * More than 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * SGOT/SGPT less than 2.5 times ULN * Alkaline phosphatase less than 2.5 times ULN Renal: * Creatinine less than 1.5 times ULN * Creatinine clearance at least 70 mL/min * BUN less than 1.5 times ULN Cardiovascular: * Ejection fraction greater than 50% OR * Shortening fraction greater than 27% * No evidence of myocardial ischemia on EKG if over 40 years of age Other: * HIV negative * No AIDS-related illness * No frequent vomiting or medical condition that would preclude oral medication (e.g., partial bowel obstruction) * No other malignancy within the past 2 years except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 2 weeks since prior biologic therapy or immunotherapy Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: * See Disease Characteristics Radiotherapy: * See Disease Characteristics * At least 6 weeks since prior radiotherapy and recovered * At least 6 weeks since prior brachytherapy or radiosurgery Surgery: * See Disease Characteristics * Recovered from prior major surgery

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

Sponsors & Collaborators

Study Sites (4)

NYU Cancer Institute at New York University Medical Center

New York, New York, 10016, United States

Location

Columbus Children's Hospital

Columbus, Ohio, 43205-2696, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Princess Margaret Hospital for Children

Perth, Western Australia, 6001, Australia

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsMedulloblastomaGlioblastomaAstrocytomaOligodendrogliomaGliomaPinealomaFamilial ependymomaGliosarcomaEpendymoma

Interventions

FilgrastimCarboplatinTemozolomideThiotepaPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBrain DiseasesCentral Nervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeuroectodermal Tumors, PrimitiveNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsCoordination ComplexesOrganic ChemicalsDacarbazineTriazenesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhosphoramidesOrganophosphorus CompoundsTriethylenephosphoramideAziridinesAzirinesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Sharon L. Gardner, MD

    NYU Langone Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 11, 2001

First Posted

January 27, 2003

Study Start

October 1, 2000

Primary Completion

May 1, 2007

Last Updated

March 28, 2011

Record last verified: 2011-03

Locations

US(3)AU(1)