Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT00005955

Collaborator

National Cancer Institute (NCI) (NIH)

Location

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors Neuroblastoma	Drug: temozolomide	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2000

Actual Study Completion Date :

Sep 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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