NCT00014573

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 bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Vaccines made from a person's white blood cells and tumor cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and vaccine therapy followed by bone marrow or peripheral stem cell transplantation and interleukin-2 in treating patients who have recurrent or refractory brain cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Aug 1998

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

August 1, 1998

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2001

Completed
3 years until next milestone

First Posted

Study publicly available on registry

April 5, 2004

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
Last Updated

April 8, 2013

Status Verified

April 1, 2013

Enrollment Period

6.2 years

First QC Date

April 10, 2001

Last Update Submit

April 5, 2013

Conditions

Brain and Central Nervous System Tumors

Keywords

childhood infratentorial ependymomachildhood supratentorial ependymomachildhood central nervous system germ cell tumorrecurrent adult brain tumoradult brain stem gliomaadult medulloblastomaadult glioblastomachildhood high-grade cerebral astrocytomaadult anaplastic astrocytomachildhood choroid plexus tumorchildhood grade III meningiomaadult anaplastic ependymomaadult mixed gliomaadult central nervous system germ cell tumoradult ependymoblastomarecurrent childhood brain stem gliomarecurrent childhood supratentorial primitive neuroectodermal tumorrecurrent childhood cerebral astrocytomarecurrent childhood medulloblastomaadult choroid plexus tumorrecurrent childhood ependymomaadult grade III meningiomaadult giant cell glioblastomaadult gliosarcoma

Interventions

aldesleukinBIOLOGICAL
autologous tumor cell vaccineBIOLOGICAL
filgrastimBIOLOGICAL
sargramostimBIOLOGICAL
therapeutic autologous lymphocytesBIOLOGICAL
carmustineDRUG
cisplatinDRUG
cyclophosphamideDRUG
paclitaxelDRUG
autologous bone marrow transplantationPROCEDURE
conventional surgeryPROCEDURE
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed active recurrent or refractory primary high-grade brain tumor * Tumor must be surgically accessible * Bidimensionally measurable disease by clinical exam, CT scan, or x-ray * Disease must be outside a previously irradiated field or have progressed or developed after radiotherapy * Previously treated metastatic bony lesions are not considered measurable * No previously irradiated metastatic disease site unless no response or clear progression on imaging PATIENT CHARACTERISTICS: Age: * 65 and under Performance status: * CALGB 0-2 Life expectancy: * More than 3 months Hematopoietic: * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Liver function less than 2.5 times normal unless due to disease * No active hepatitis B or C Renal: * Creatinine less than 1.5 mg/dL * Creatinine clearance greater than 60 mL/min Cardiovascular: * Left ventricular ejection fraction greater than 50% by MUGA or 2-D echocardiogram * Electrocardiogram normal Pulmonary: * FEV1 and DLCO greater than 50% predicted OR * Clearance by pulmonologist Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No serious underlying co-morbid disease or other medical or psychiatric factor that would preclude study * Able to be weaned off steroids after surgery PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Recovered from prior conventional chemotherapy Endocrine therapy: * No concurrent steroid therapy for mass effect Radiotherapy: * See Disease Characteristics * Recovered from prior conventional radiotherapy Surgery: * See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsMedulloblastomaGlioblastomaAstrocytomaChoroid Plexus NeoplasmsEpendymomaGliomaNeuroectodermal Tumors, PrimitiveFamilial ependymomaMeningiomaGliosarcoma

Interventions

aldesleukinFANG vaccineFilgrastimsargramostimCarmustineCisplatinCyclophosphamidePaclitaxelPeripheral 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 TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCerebral Ventricle NeoplasmsNeoplasms, Vascular TissueMeningeal Neoplasms

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 CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicDiterpenesTerpenesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Esteban Abella, MD

    Barbara Ann Karmanos Cancer Institute

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

April 10, 2001

First Posted

April 5, 2004

Study Start

August 1, 1998

Primary Completion

October 1, 2004

Study Completion

October 1, 2004

Last Updated

April 8, 2013

Record last verified: 2013-04

Locations

US(1)