Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme

• Status: Completed
• Trial end date: 2003-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Temozolomide

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