NCT00007982

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: This phase II trial is studying how well chemotherapy and peripheral stem cell transplant work in treating patients with central nervous system cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 1999

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

April 1, 1999

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2001

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

February 4, 2013

Status Verified

July 1, 2007

Enrollment Period

5.8 years

First QC Date

January 6, 2001

Last Update Submit

February 1, 2013

Conditions

Brain and Central Nervous System TumorsHead and Neck CancerLymphoma

Keywords

recurrent adult brain tumoradult medulloblastomaadult oligodendrogliomarecurrent esthesioneuroblastoma of the paranasal sinus and nasal cavityadult anaplastic astrocytomaadult central nervous system germ cell tumorprimary central nervous system non-Hodgkin lymphomaadult anaplastic oligodendroglioma

Outcome Measures

Primary Outcomes (5)

  • Response rate

  • Disease-free suvival

  • Overall survival

  • Toxicity

  • Quality of life

Interventions

filgrastimBIOLOGICAL
carmustineDRUG
cisplatinDRUG
cyclophosphamideDRUG
etoposideDRUG
thiotepaDRUG
adjuvant therapyPROCEDURE
autologous bone marrow transplantationPROCEDURE
bone marrow ablation with stem cell supportPROCEDURE
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed malignant tumors * Anaplastic astrocytoma * Oligodendroglioma * Germ cell tumor * Medulloblastoma * Primary neuroectodermal tumor * Esthesioneuroblastoma * CNS lymphoma (primary or systemic disease) * Multifocal intracranial disease allowed * No extraneural metastases (except controlled systemic lymphoma) * Pretreatment considerations based on tumor type * Anaplastic astrocytoma: * Recurrent disease * Any treatment at diagnosis allowed (carmustine dose limited to 480 mg/m2) * Chemotherapy not required at recurrence * Oligodendroglioma: * Disease response (at least minor) to conventional chemotherapy OR * Recurrent disease * Esthesioneuroblastoma: * Attempted complete surgical resection * Disease progression after radiotherapy * Response to chemotherapy regimen comprising cyclophosphamide, etoposide, and cisplatin * CNS lymphoma: * Disease refractory to methotrexate OR * Failure after initial treatment with methotrexate OR * Considered at high risk for disease relapse despite initial response * Radiographic or pathological confirmation of recurrent disease required * Not eligible for other high priority national or institutional clinical studies PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG or Zubrod 0-1 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Creatinine less than 1.5 times normal Cardiovascular: * LVEF at least 45% Pulmonary: * DLCO at least 60% predicted OR * Approval of pulmonologist Other: * Not pregnant or nursing * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * No other concurrent chemotherapy Endocrine therapy: * No concurrent anticancer hormonal therapy * No concurrent steroids as antiemetics Radiotherapy: * See Disease Characteristics Surgery: * See Disease Characteristics Other: * No concurrent barbiturates or acetaminophen * Participation in other concurrent supportive care or gene therapy trials allowed

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

Sponsors & Collaborators

Study Sites (1)

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsHead and Neck NeoplasmsLymphomaBrain NeoplasmsMedulloblastomaOligodendrogliomaEsthesioneuroblastoma, OlfactoryAstrocytoma

Interventions

FilgrastimCarmustineCisplatinCyclophosphamideEtoposideThiotepaChemotherapy, AdjuvantPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBrain DiseasesCentral Nervous System DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeuroectodermal Tumors, PrimitiveNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroblastomaNeuroectodermal Tumors, Primitive, PeripheralOlfactory Nerve DiseasesCranial Nerve Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsNitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesTriethylenephosphoramideAziridinesAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCombined Modality TherapyTherapeuticsDrug TherapyHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTransplantationSurgical Procedures, Operative

Study Officials

  • Charles S. Hesdorffer, MD

    Herbert Irving Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2001

First Posted

January 27, 2003

Study Start

April 1, 1999

Primary Completion

February 1, 2005

Study Completion

May 1, 2008

Last Updated

February 4, 2013

Record last verified: 2007-07

Locations

US(1)