Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma

April 2, 2013 updated by: Memorial Sloan Kettering Cancer Center

A Phase I Study of Extended Low Dose Temozolomide (SCH 52365, Temodar (R)) and Carmustine (BCNU) in the Treatment of Malignant Gliomas After 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 chemotherapy drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy following radiation therapy in treating patients who have malignant glioma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the safety and efficacy of extended low-dose temozolomide when combined with carmustine after radiotherapy in patients with malignant glioma.
  • Determine the maximum tolerated dose of this combination in this patient population.
  • Determine time to progression as measured from baseline gadolinium-enhanced magnetic resonance imaging in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of temozolomide.

Patients receive oral temozolomide once daily on days 1-28 and carmustine IV over 1-3 hours beginning within 72 hours after starting temozolomide. Courses repeat every 8 weeks for up to 1 year in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study within 1-2 years.

Study Type

Interventional

Phase

  • Phase 1

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, 10021
        • Memorial Sloan-Kettering 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 malignant glioma

    • Glioblastoma
    • Gliosarcoma
    • High-grade glioma
    • Anaplastic astrocytoma
    • Anaplastic mixed oligoastrocytoma
    • Anaplastic oligodendroglioma
    • Anaplastic ependymoma
  • Must have completed radiotherapy

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • More than 3 months

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic:

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • SGOT/SGPT less than 3 times ULN
  • Alkaline phosphatase less than 2 times ULN

Renal:

  • BUN less than 1.5 times ULN
  • Creatinine less than 1.5 times ULN

Pulmonary:

  • Pulmonary function test with diffusion greater than 50 OR
  • Clearance by the pulmonary service

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No AIDS-related illness
  • No nonmalignant systemic disease that would preclude study
  • No acute infection requiring IV antibiotics
  • No psychiatric condition that would preclude study compliance
  • No frequent vomiting or medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction)
  • No other prior or concurrent malignancy except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy
  • No prior biologic therapy

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 2 weeks since prior radiotherapy

Surgery:

  • Not specified

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

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

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

December 1, 1999

Primary Completion (ACTUAL)

June 1, 2003

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

May 2, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

April 4, 2013

Last Update Submitted That Met QC Criteria

April 2, 2013

Last Verified

March 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067793
  • MSKCC-99114
  • NCI-G00-1765

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.

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