Clinical trial NCT00313729: Temozolomide in Treating Patients With Low-Grade Glioma
Official title: A Phase II Study of Temozolomide (TEMODAR) in the Treatment of Adult Patients With Supratentorial Low Grade Glioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: CNS Tumor, Adult
Keywords: adult oligodendroglioma
adult mixed glioma
adult diffuse astrocytoma
adult pilocytic astrocytoma
adult pineal gland astrocytoma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2006-04-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with supratentorial low-grade glioma.

Detailed description: OBJECTIVES:

Primary

* Determine the efficacy of temozolomide, defined as response rate (complete and partial response), in patients with supratentorial mixed low-grade glioma.

Secondary

* Assess the safety profile of temozolomide in patients with supratentorial low-grade glioma.
* Assess the time to tumor progression in patients treated with temozolomide.

OUTLINE: Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically proven supratentorial low-grade (grade II) glioma of any of the following histologic subtypes:

  * Oligodendroglioma
  * Astrocytoma
  * Oligoastrocytoma
* Has undergone surgical resection or biopsy within 35 days after diagnosis of low-grade glioma

  * Study treatment must begin between 14 days and 4 months after surgical resection or biopsy
* Evaluable disease by gadolinium-MRI

PATIENT CHARACTERISTICS:

* Karnofsky performance status 60-100%
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 10 g/dL
* Creatinine \< 1.5 times upper limit of normal (ULN)
* BUN \< 1.5 times ULN
* Bilirubin \< 1.5 times ULN
* SGOT \< 2.5 times ULN
* Alkaline phosphatase \< 2 times ULN
* Life expectancy \> 12 weeks
* No nonmalignant systemic disease resulting in the patient being a poor medical risk
* No acute infection requiring intravenous antibiotics
* No frequent vomiting or medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction)
* No other concurrent malignancies except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin

  * Prior malignancies must be in remission for ≥ 5 years
* No known HIV positivity
* No AIDS-related illness
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior radiotherapy, interstitial brachytherapy, or radiosurgery for low-grade glioma
* No prior biological therapy or chemotherapy for low-grade glioma
* No other concurrent chemotherapy
* No concurrent radiotherapy or biological therapy
* No concurrent prophylactic growth factors
* No concurrent epoetin alfa
* No other concurrent investigational drugs

Primary outcomes:
measure: Response Rate (Complete and Partial Response)
timeFrame: 12 months
Secondary outcomes:
measure: Time to Tumor Progression
timeFrame: time from registration until date of the first documented progression, an average of 1 year
measure: Safety Profile
timeFrame: Time from registration up to 13 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Susan M. Chang, MD
role: STUDY_CHAIR
References: