Temozolomide and Radiation Therapy in Treating Young Patients With Pontine Glioma

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temozolomide together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation therapy works in treating young patients with pontine glioma.

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

Details

• Lead Sponsor: Children's Cancer and Leukaemia Group
• Treatments: Dacarbazine; Motexafin gadolinium; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

• Newly diagnosed diffuse intrinsic lesion centered in the pons on MRI

• No requirement for histological diagnosis

• Clinical history < 6 months

• Clinical findings must include at least 1 of the 3 following signs of brainstem tumor:

• Cranial nerve deficit

• Long tract signs

• Ataxia

Exclusion criteria:

• Focal lesions of brainstem

• Predominantly exophytic tumors

PATIENT CHARACTERISTICS:

Inclusion criteria:

• Karnofsky performance status (PS) or Lansky PS 60-100% (unless reason for decrease in status is a direct result of neurological involvement of the brainstem glioma)

• Life expectancy > 12 weeks

• Absolute neutrophil count ≥ 1,000/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 10 g/dL

• Urea and serum creatinine < 1.5 times upper limit of normal (ULN)

• Total and direct bilirubin < 1.5 times ULN

• AST and ALT < 3 times ULN

• Negative pregnancy test within 7 days prior to administration of temozolomide for women of childbearing potential

Exclusion criteria:

• Frequent vomiting and/or medical condition, that could interfere with oral medication intake (e.g., partial bowel obstruction)

• Pregnant or breast-feeding women

PRIOR CONCURRENT THERAPY:

Exclusion criteria:

• Prior chemotherapy or radiotherapy

• Other concurrent investigational drugs

• Other concurrent chemotherapy, immunotherapy, or biologic therapy