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A Phase II Study of Temozolomide (TEMODAR) in the Treatment of Adult Patients With Supratentorial Low Grade Glioma

Phase 2
18 Years
Open (Enrolling)
Brain and Central Nervous System Tumors

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Trial Information

A Phase II Study of Temozolomide (TEMODAR) in the Treatment of Adult Patients With Supratentorial Low Grade Glioma



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


- Assess the safety profile of temozolomide in patients with supratentorial low-grade

- 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.

Inclusion Criteria


- 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


- 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


- See Disease Characteristics

- No prior radiotherapy, interstitial brachytherapy, or radiosurgery for low-grade

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (complete and partial response)

Outcome Time Frame:


Safety Issue:


Principal Investigator

Susan M. Chang, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco


United States: Food and Drug Administration

Study ID:




Start Date:

May 1999

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult oligodendroglioma
  • adult mixed glioma
  • adult diffuse astrocytoma
  • adult pilocytic astrocytoma
  • adult pineal gland astrocytoma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115