Carboplatin Plus Irinotecan in Treating Patients With Glioblastoma Multiforme

March 25, 2011 updated by: NYU Langone Health

A Phase I/II Trial of CPT-11 With Carboplatin in Patients With Glioblastoma Multiforme Prior to Radiation Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 60 and over), ECOG performance status (0-1 vs 2), and extent of resection (total vs 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)

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU School of Medicine's Kaplan Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Michael L. Gruber, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1999

Primary Completion (Actual)

October 1, 2001

Study Registration Dates

First Submitted

February 2, 2001

First Submitted That Met QC Criteria

September 3, 2003

First Posted (Estimate)

September 4, 2003

Study Record Updates

Last Update Posted (Estimate)

March 28, 2011

Last Update Submitted That Met QC Criteria

March 25, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068435
  • P30CA016087 (U.S. NIH Grant/Contract)
  • NYU-9902
  • P-UPJOHN-986475197
  • NCI-G00-1909

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Brain and Central Nervous System Tumors

Clinical Trials on carboplatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe