NCT00010036

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining carboplatin with irinotecan in treating patients who have glioblastoma multiforme.

Trial Health

80
On Track

Trial Health Score

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

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1999

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2001

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2001

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

September 4, 2003

Completed
Last Updated

March 28, 2011

Status Verified

March 1, 2011

Enrollment Period

2.4 years

First QC Date

February 2, 2001

Last Update Submit

March 25, 2011

Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastomaadult giant cell glioblastomaadult gliosarcoma

Interventions

carboplatinDRUG
irinotecan hydrochlorideDRUG
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed glioblastoma multiforme * Measurable disease * No CNS metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 OR * Karnofsky 70-100% Life expectancy: * At least 12 weeks Hematopoietic: * Granulocyte count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin at least 9.0 g/dL Hepatic: * Bilirubin no greater than 1.5 mg/dL * SGOT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver involvement) * No known Gilbert's syndrome Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * No myocardial infarction within the past 6 months * No congestive heart failure requiring therapy Other: * HIV negative * No active or uncontrolled infection * No psychiatric disorder that would preclude study * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No uncontrolled diabetes mellitus (i.e., random blood sugar of 200 mg or more) * No other severe disease that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunotherapy or biologic therapy * No concurrent sargramostim (GM-CSF) * No concurrent filgrastim (G-CSF) with course 1 * No concurrent immunotherapy Chemotherapy: * No prior chemotherapy * No other concurrent chemotherapy Endocrine therapy: * Must have maintained a stable or decreasing dose of corticosteroids for 2 weeks prior to study * Concurrent corticosteroids for cerebral edema allowed * No concurrent anticancer hormonal therapy Radiotherapy: * No prior radiotherapy * No concurrent radiotherapy Surgery: * At least 2 weeks since prior surgery Other: * No other concurrent investigational agent or participation on any other clinical study * No concurrent immunosuppressive drugs * No concurrent phenobarbital or valproic acid * No concurrent anticonvulsants except carbamazepine or gabapentin * No concurrent prochlorperazine on day of irinotecan treatment

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

Sponsors & Collaborators

Study Sites (1)

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsGlioblastomaGliosarcoma

Interventions

CarboplatinIrinotecanRadiotherapy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesAstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsCamptothecinAlkaloidsHeterocyclic CompoundsTherapeutics

Study Officials

  • Michael L. Gruber, MD

    NYU Langone Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 2, 2001

First Posted

September 4, 2003

Study Start

May 1, 1999

Primary Completion

October 1, 2001

Last Updated

March 28, 2011

Record last verified: 2011-03

Locations

US(1)