Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Chemotherapy combined with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of temozolomide followed by radiation therapy in treating children who have newly diagnosed malignant central nervous system tumors.
Full description
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.
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
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Histologically confirmed newly diagnosed malignant central nervous system tumor not requiring immediate radiotherapy
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Patients with diffuse pontine tumors do not require histological confirmation
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Eligible types include the following:
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Ependymoma
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Malignant glioma
- Anaplastic astrocytoma
- Glioblastoma multiforme
- Anaplastic oligodendroglioma
- Gliosarcoma
- Anaplastic mixed oligoastrocytoma
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Brainstem glioma
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Primitive neuroectodermal tumor
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Nongerminoma germ cell tumor
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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
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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
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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