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Temozolomide and O6-benzylguanine in Treating Patients With Newly Diagnosed, Recurrent, or Progressive Anaplastic Glioma

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 I trial to study the effectiveness of combining temozolomide and O6-benzylguanine in treating patients who have newly diagnosed, recurrent, or progressive anaplastic glioma.

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:

  • - Part I: - Histologically confirmed, newly diagnosed glioblastoma multiforme or anaplastic astrocytoma (closed to accrual 12/19/2000) - Parts I and II: - Histologically confirmed astrocytic, oligodendroglial, or mixed glial tumor.
  • - Grade III or higher.
  • - Recurrent or progressive after radiotherapy.
  • - Evaluable residual disease by contrast-enhanced MRI or CT scan.
PATIENT CHARACTERISTICS: Age:
  • - 18 and over.
Performance status:
  • - Karnofsky 60-100% Life expectancy: - Not specified.
Hematopoietic:
  • - Granulocyte count at least 1,500/mm3.
  • - Platelet count at least 100,000/mm3.
Hepatic:
  • - SGOT no greater than 2.5 times upper limit of normal.
  • - Bilirubin normal.
Renal:
  • - Creatinine no greater than 1.5 mg/dL OR.
  • - Creatinine clearance greater than 60 mL/min.
  • - BUN no greater than 25 mg/dL.
Other:
  • - Not pregnant or nursing.
  • - Negative pregnancy test.
  • - Fertile patients must use effective contraception during and for 2 months after study.
PRIOR CONCURRENT THERAPY: Biologic therapy:
  • - At least 6 weeks since prior biologic therapy and recovered.
Chemotherapy:
  • - At least 2 weeks since prior chemotherapy (including but not limited to topotecan) and recovered.
  • - Patients in trials with one of the following treatment combinations are allowed to enroll 6 weeks after receiving carmustine (BCNU): - BCNU on day 1.
  • - BCNU on day 1 and topotecan on days 1, 8, 15, 22, 29, and 36.
  • - BCNU on day 1 and irinotecan on days 1, 8, 15, and 22.
Endocrine therapy:
  • - Patients on corticosteroids must be on a stable dose for at least 2 weeks before study.
  • - At least 6 weeks since other prior endocrine therapy and recovered.
Radiotherapy:
  • - See Disease Characteristics.
  • - At least 6 weeks since prior radiotherapy and recovered.
Surgery: - Not specified

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.

 NCT00006474
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 1
Lead Sponsor

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

 Duke University
Principal Investigator

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

 Henry S. Friedman, MD
Principal Investigator Affiliation Duke Cancer Institute
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 dose of O6-benzylguanine (O6-BG) effective in producing complete suppression of tumor O6-alkylguanine-DNA alkyltransferase activity in patients with newly diagnosed (closed to accrual 12/19/2000) or recurrent or progressive cerebral anaplastic glioma.
  • - Determine the maximum tolerated dose of temozolomide administered after O6-BG in these patients.
  • - Determine the toxicity of this regimen in these patients.
  • - Determine the anti-tumor response in patients treated with this regimen.
OUTLINE: This is a dose-escalation, multicenter study.
  • - Part I: Patients receive escalating doses of O6-benzylguanine (O6-BG) IV continuously for 49 hours until the dose that produces the target depletion of tumor O6-alkylguanine-DNA alkyltransferase (AGT) is determined.
Patients undergo a craniotomy after completion of the O6-BG infusion. (closed to accrual 12/19/2000)
  • - Part II: After determination of the O6-BG dose in Part I, patients with recurrent malignant gliomas receive O6-BG IV continuously for 49 hours beginning on day 1.
Patients also receive oral temozolomide on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. 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 at which no more than 1 of 6 patients experiences dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 20-30 patients (with 14 patients participating in Part II) will be accrued for this study.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Duke Comprehensive Cancer Center, Durham, North Carolina

Status

Address

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710

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