CompletedPhase 3

S0001 RT and Carmustine With or Without O6BG in Patients With New Glioblastoma Multiforme or Gliosarcoma

United States183 participantsStarted 2001-09

Plain-language summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. O6-benzylguanine may help carmustine kill more tumor cells by making tumor cells more sensitive to the drug. It is not yet known whether radiation therapy and carmustine are more effective with or without O6-benzylguanine. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus carmustine with or without O6-benzylguanine in treating patients who have newly diagnosed glioblastoma multiforme or gliosarcoma.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Histologically confirmed glioblastoma multiforme or gliosarcoma * Biopsy or surgical resection within the past 28 days * MRI\* with gadolinium performed before registration * Patients who undergo a simple biopsy only require preoperative MRI\* with gadolinium * No more than 2 noncontiguous tumor sites based on T2-weighted MRI (in 3 dimensions)\* * No prior radiotherapy-delivered cephalad to the interspace between the seventh cervical and the first thoracic vertebral body NOTE: \*If an MRI is not medically feasible, patients may have a CT scan with contrast PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 8 g/dL Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) * SGOT/SGPT no greater than 2 times ULN * Alkaline phosphatase no greater than 2 times ULN * PT/PTT no greater than 1.2 times ULN Renal: * Not specified Cardiac: * No severe cardiac disease, including any of the following: * Uncontrolled arrhythmias or conduction defects * Major problems with edema (e.g., residual swelling in the legs from deep vein thrombosis) * Recent coronary artery disease * Poorly controlled hypertension (i.e., diastolic blood pressure greater than 110 mm Hg and/or systolic blood pressure greater than 180 mm Hg) Pulmonary: * DL…

What they're measuring

Survival

Timeframe: assessed every 6 weeks for 42 weeks, then every 4 months for one year, followed by every 6 months for years 2 through 5

Trial details

NCT IDNCT00017147

SponsorSWOG Cancer Research Network

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2006-05