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

• Status: Completed
• Trial end date: 2002-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dacarbazine; Temozolomide

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