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A Phase II Study of Prolonged Daily Temozolomide for Low-Grade Glioma

Phase 2
18 Years
Not Enrolling
Glioma, Astrocytoma, Oligodendroglioma

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Trial Information

A Phase II Study of Prolonged Daily Temozolomide for Low-Grade Glioma

- Treatment with temozolomide is based upon an 11-week cycle (7 weeks on the drug and 4
weeks off). Patients will receive temozolomide once daily for 49 days, then have 28
days without taking temozolomide.

- Every two to four weeks a physical and neurological examination and blood work will be
performed. A magnetic resonance imaging (MRI) scan of the patient's brain will be done
approximately every three months (before each cycle of treatment).

- Treatment may continue for a maximum of a year and a half based on 6 eleven-week
cycles. The actual duration of therapy will depend upon the response to treatment and
the development of side effects or toxicity.

Inclusion Criteria:

- Histological confirmation of a low-grade glioma (astrocytoma, oligodendroglioma, or
mixed oligoastrocytoma)

- Measurable disease on MRI

- Patients that have undergone recent resection for newly diagnosed or recurrent or
progressive tumor are eligible if they have recovered from the effects of surgery.

- Patients with recurrent disease my have had one prior chemotherapy regimen

- Older than 18 years of age.

- Karnofsky performance status (KPS) performance score of > 70%

- Adequate hematologic, renal and liver functions,

- Life expectancy of greater than 12 weeks.

- Negative pregnancy test.

Exclusion Criteria:

- Prior treatment with temozolomide

- Patients who are not neurologically stable

- Acute infection treated with intravenous antibiotics

- Non-malignant systemic disease

- Frequent vomiting, inability to swallow or a medical condition that could interfere
with oral medication.

- Previous or concurrent malignancies at other sites, with the exception of surgically
cured carcinoma in-situ of the cervix, and basal or squamous cell carcinoma of the

- HIV positive or AIDS-related illness

- Pregnant or nursing women

- Patients with allergy to decarbazine.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the effects temozolomide has on low-grade gliomas

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Patrick Wen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

September 2001

Completion Date:

September 2009

Related Keywords:

  • Glioma
  • Astrocytoma
  • Oligodendroglioma
  • low-grade glioma
  • astrocytoma
  • oligodendroglioma
  • oligoastrocytoma
  • temozolomide
  • mixed oligoastrocytoma
  • Astrocytoma
  • Glioma
  • Oligodendroglioma



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Brigham and Women's Hospital Boston, Massachusetts  02115