Clinical trial NCT00003464: Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme
Official title: Phase II Treatment of Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme With Temodal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain and Central Nervous System Tumors
Keywords: adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-08-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Henry S. Friedman, MD
role: STUDY_CHAIR
References: