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Phase II Treatment of Children With Newly Diagnosed Malignant Central Nervous System Tumors With Temozolomide Prior to Radiation Therapy

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

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Trial Information

Phase II Treatment of Children With Newly Diagnosed Malignant Central Nervous System Tumors With Temozolomide Prior to Radiation Therapy


- Determine the response rate to treatment with temozolomide in children with newly
diagnosed malignant central nervous system tumors.

- Determine the toxicity of this treatment in these patients.

- Determine the overall survival in these patients for 18 months following the study
after receiving this treatment.

OUTLINE: Patients are stratified according to type of disease (ependymoma vs brain stem
glioma vs malignant glioma vs other).

Patients receive oral temozolomide on days 1-5. Treatment repeats every 28 days for a
maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
Patients with a partial or complete response may receive an additional 8 courses of
temozolomide following radiotherapy.

PROJECTED ACCRUAL: A maximum of 100 patients (25 per stratum) will be accrued for this study
over 24-36 months.

Inclusion Criteria


- Histologically confirmed newly diagnosed malignant central nervous system tumor not
requiring immediate radiotherapy

- Patients with diffuse pontine tumors do not require histological confirmation

- Eligible types include the following:

- Ependymoma

- Malignant glioma

- Anaplastic astrocytoma

- Glioblastoma multiforme

- Anaplastic oligodendroglioma

- Gliosarcoma

- Anaplastic mixed oligoastrocytoma

- Brainstem glioma

- Primitive neuroectodermal tumor

- Nongerminoma germ cell tumor

- At least one bidimensionally measurable lesion

- At least 1.5 cm2 within 72 hours of surgical resection or greater than 14 days
after surgery

- Diffuse pontine tumors are not required to be measurable

- Neurologically stable



- 4 to 21

Performance status:

- Karnofsky or Lansky 70-100%

Life expectancy:

- Greater 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)

- Alkaline phosphatase less than 2 times ULN

- SGOT and SGPT less than 2.5 times ULN


- BUN and creatinine less than 1.5 times ULN


- Must be able to swallow capsules

- No acute infection treated with intravenous antibiotics

- No nonmalignant systemic disease that makes patient a poor medical risk

- No frequent vomiting or medical condition that may interfere with oral medication
intake (e.g., partial bowel obstruction)

- No other prior or concurrent malignancies except surgically cured carcinoma in situ
of the cervix or basal or squamous cell carcinoma of the skin

- HIV negative

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


Biologic therapy:

- No more than one prior biologic therapy regimen

- No concurrent biologic therapy

- No concurrent growth factors or epoetin alfa


- No more than one prior chemotherapy regimen

- No other concurrent chemotherapy

Endocrine therapy:

- No increasing doses of steroids within one week of study


- See Disease Characteristics

- No concurrent radiotherapy


- At least 2 weeks, but no greater than 4 weeks, since prior surgical resection and


- No other concurrent investigational drugs

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Henry S. Friedman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke University


United States: Federal Government

Study ID:




Start Date:

August 2000

Completion Date:

September 2002

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Neuroblastoma
  • childhood infratentorial ependymoma
  • childhood low-grade cerebral astrocytoma
  • childhood supratentorial ependymoma
  • childhood craniopharyngioma
  • localized resectable neuroblastoma
  • regional neuroblastoma
  • disseminated neuroblastoma
  • stage 4S neuroblastoma
  • childhood high-grade cerebral astrocytoma
  • childhood oligodendroglioma
  • childhood choroid plexus tumor
  • childhood grade I meningioma
  • childhood grade II meningioma
  • childhood grade III meningioma
  • untreated childhood supratentorial primitive neuroectodermal tumor
  • untreated childhood cerebellar astrocytoma
  • untreated childhood medulloblastoma
  • untreated childhood visual pathway and hypothalamic glioma
  • newly diagnosed childhood ependymoma
  • childhood central nervous system choriocarcinoma
  • childhood central nervous system embryonal tumor
  • childhood central nervous system mixed germ cell tumor
  • childhood central nervous system teratoma
  • childhood central nervous system yolk sac tumor
  • Nervous System Neoplasms
  • Neuroblastoma
  • Central Nervous System Neoplasms



Duke Comprehensive Cancer Center Durham, North Carolina  27710