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Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme

Study Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating adults with newly diagnosed primary malignant 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 proven, newly diagnosed, supratentorial malignant glioblastoma multiforme not requiring immediate radiation therapy.
  • - At least 1 bidimensionally measurable lesion.
PATIENT CHARACTERISTICS: Age:
  • - 18 and over.
Performance status:
  • - Karnofsky 70-100% Life expectancy: - Greater than 12 weeks.
Hematopoietic:
  • - Absolute neutrophil count at least 1500/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 and SGPT less than 2.5 times ULN.
  • - Alkaline phosphatase less than 2 times ULN.
Renal:
  • - BUN less than 1.5 times ULN.
  • - Creatinine less than 1.5 times ULN.
Other:
  • - Must be neurologically stable.
  • - No systemic disease.
  • - No acute infection requiring intravenous antibiotics.
  • - No frequent vomiting.
  • - No other medical condition that would interfere with oral medication intake such as partial bowel obstruction.
  • - No prior or concurrent malignancies except: - Surgically cured carcinoma in situ of the cervix.
  • - Basal or squamous cell carcinoma of the skin.
  • - HIV negative.
  • - No AIDS-related illness.
  • - Not pregnant or nursing.
  • - Fertile patients must use effective contraception.
PRIOR CONCURRENT THERAPY: Biologic therapy:
  • - No prior biologic therapy.
  • - No concurrent biologic therapy (growth factors or erythropoietin) Chemotherapy: - No prior chemotherapy.
  • - No other concurrent chemotherapy.
Endocrine therapy:
  • - Concurrent steroid allowed (must be on stable dose for at least 1 week prior to study) Radiotherapy: - No prior radiation therapy.
  • - No prior interstitial brachytherapy.
  • - No prior radiosurgery to the brain.
  • - Not requiring immediate radiation therapy.
  • - No concurrent radiotherapy.
Surgery:
  • - Recovered from any effects of prior surgery.
  • - At least 2 weeks since prior surgical resection.
Other: - No other concurrent investigational drugs

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.

 NCT00003464
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.

 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 University
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 antitumor activity of temozolomide in adults with newly diagnosed glioblastoma multiforme.
  • - Define the relationship between tumor O6-alkylguanine-DNA alkyltransferase activity and tumor response in these patients.
  • - Define the relationship between tumor DNA mismatch repair activity and tumor response to temozolomide.
OUTLINE: Patients receive temozolomide orally once daily on days 1-5. Treatment courses are repeated every 28 days. In the absence of disease progression and toxicity, patients receive up to 4 courses of treatment prior to radiation therapy. After radiation therapy, patients demonstrating partial or complete response may receive an additional 12 courses of treatment. Patients are followed every 8-12 weeks for 2 years. PROJECTED ACCRUAL: This study will accrue 50 patients.

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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