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Phase II Treatment of Adults and Children With Progressive Low Grade Gliomas With Temodal

Phase 2
4 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

Phase II Treatment of Adults and Children With Progressive Low Grade Gliomas With Temodal


- Assess the response rate in patients with progressive low-grade gliomas treated with

- Determine the activity of this drug, in terms of stabilizing growth of progressive
low-grade gliomas, in adult patients.

OUTLINE: Patients are stratified by disease type (pilocytic astrocytoma, mixed glioma,
well-differentiated oligodendroglioma, and nonbiopsied optic pathway glioma or pontine

Patients receive temozolomide orally once daily on days 1-5. Courses repeat every 28 days.
In the absence of disease progression or unacceptable toxicity, patients may continue with
treatment until tumor has remained stable for 12 courses.

Patients are followed every 8-12 weeks for 2 years.

PROJECTED ACCRUAL: A total of 36-100 patients (9-25 per stratum) will be accrued for this
study within 3 years.

Inclusion Criteria


- Histologically confirmed progressive, primary, intracranial, supratentorial,
low-grade glioma including:

- Astrocytoma

- Oligodendroglioma

- Mixed glioma

- Optic pathway glioma*

- Pontine glioma* NOTE: *Biopsy not required

- Patients with optic pathway glioma must also meet the following criteria:

- Progressive loss of vision as defined by doubling of octaves

- Visual acuity loss not explained by other causes

- Increase in proptosis of greater than 3 mm

- Increase in diameter of optic nerve of at least 2 mm on neuroimaging

- Increase in distribution of tumor involving optic tracts or optic radiations as
indicated by CT scan or MRI



- 4 and over

Performance status:

- Karnofsky 70-100%

Life expectancy:

- More than 12 weeks


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 10 g/dL


- 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


- Creatinine less than 1.5 times ULN

- BUN less than 1.5 times ULN


- Must be neurologically stable

- No systemic disease

- No acute infection requiring IV antibiotics

- No frequent vomiting

- No other medical condition that would interfere with oral medication (e.g., partial
bowel obstruction)

- No other prior or concurrent malignancies except:

- Surgically cured carcinoma in situ of the cervix

- Basal or squamous cell skin cancer

- HIV negative

- No AIDS-related illness

- Not pregnant or nursing

- Fertile patients must use effective contraception


Biologic therapy:

- No concurrent biologic therapy (growth factors or epoetin alfa)


- At least 6 weeks since prior chemotherapy unless evidence of disease progression

- No other concurrent chemotherapy

Endocrine therapy:

- Not specified


- At least 6 weeks since prior radiotherapy unless evidence of disease progression

- No concurrent radiotherapy


- At least 3 weeks since prior surgery unless evidence of disease progression

- Recovered from all prior surgery


- No other concurrent investigational drugs

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:


Principal Investigator

Henry S. Friedman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute


United States: Federal Government

Study ID:

1703 (CDR0000066502)



Start Date:

March 1998

Completion Date:

July 2005

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult mixed glioma
  • childhood mixed glioma
  • adult pilocytic astrocytoma
  • adult subependymoma
  • recurrent childhood cerebral astrocytoma
  • adult brain stem glioma
  • recurrent childhood brain stem glioma
  • untreated childhood brain stem glioma
  • recurrent childhood visual pathway and hypothalamic glioma
  • untreated childhood visual pathway and hypothalamic glioma
  • adult oligodendroglioma
  • adult diffuse astrocytoma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
Duke Comprehensive Cancer Center Durham, North Carolina  27710