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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
Both
Brain and Central Nervous System Tumors, Neuroblastoma

Thank you

Trial Information

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


OBJECTIVES:

- 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


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

Age:

- 4 to 21

Performance status:

- Karnofsky or Lansky 70-100%

Life expectancy:

- Greater than 12 weeks

Hematopoietic:

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

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

- Hemoglobin at least 10 g/dL

Hepatic:

- 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

Renal:

- BUN and creatinine less than 1.5 times ULN

Other:

- 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No more than one prior biologic therapy regimen

- No concurrent biologic therapy

- No concurrent growth factors or epoetin alfa

Chemotherapy:

- No more than one prior chemotherapy regimen

- No other concurrent chemotherapy

Endocrine therapy:

- No increasing doses of steroids within one week of study

Radiotherapy:

- See Disease Characteristics

- No concurrent radiotherapy

Surgery:

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

Other:

- No other concurrent investigational drugs

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Henry S. Friedman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke University

Authority:

United States: Federal Government

Study ID:

0931

NCT ID:

NCT00005955

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

Name

Location

Duke Comprehensive Cancer Center Durham, North Carolina  27710