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Carboplatin Plus Irinotecan in Treating Patients With Glioblastoma Multiforme

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00010036
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

NYU Langone Health
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Michael L. Gruber, MD
Principal Investigator Affiliation NYU Langone Health
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain and Central Nervous System Tumors
Additional Details

OBJECTIVES:

  • - Determine the maximum tolerated dose (MTD) of carboplatin and irinotecan in patients with glioblastoma multiforme.
(Phase I closed to accrual as of 6/24/02)
  • - Determine the toxic effects of this regimen in these patients.
  • - Determine the objective response in patients treated with the established MTD of this regimen.
  • - Determine time to tumor progression and survival of patients treated with this regimen.
OUTLINE: This is a dose-escalation study. Patients in the phase II portion of the study are stratified according to age (under 60 vs.#46;60 and over), ECOG performance status (0-1 vs.#46;2), and extent of resection (total vs.#46;subtotal). (Phase I closed to accrual as of 6/24/02) Within 4 weeks of surgery, patients receive carboplatin IV over 30 minutes followed by irinotecan IV over 90 minutes on day 1. Treatment repeats every 4 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of carboplatin and irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive carboplatin and irinotecan at the recommended phase II dose. (Phase I closed to accrual as of 6/24/02) After chemotherapy, all patients undergo radiotherapy. Patients are followed for 30 days. PROJECTED ACCRUAL: A total of 24-107 patients (3-54 for phase I and 21-53 for phase II) will be accrued for this study. (Phase I closed to accrual as of 6/24/02)

Contact a Trial Team

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New York, New York

Status

Address

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016