Paclitaxel Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma

• Status: Terminated
• Trial end date: 2006-09-01
• 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. Paclitaxel may make the tumor cells more sensitive to radiation therapy.

PURPOSE: Phase I trial to study the effectiveness of combining paclitaxel with radiation therapy in treating children who have newly diagnosed brain stem glioma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Philadelphia
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Newly diagnosed, diffuse, intrinsic brain stem glioma by clinical examination and magnetic resonance imaging (MRI)

• Histologic verification not required

• Intrinsic (more than 50% intra-axial) involvement of the pons, pons and medulla, pons and midbrain, or entire brain stem allowed

• Contiguous involvement of the thalamus or upper cervical cord allowed

PATIENT CHARACTERISTICS:

Age:

• 3 to 21 at diagnosis

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count greater than 1,000/mm3

• Platelet count greater than 100,000/mm3

• Hemoglobin greater than 10.0 g/dL

Hepatic:

• Bilirubin less than 1.5 times normal

• serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) less than 2.5 times normal

Renal:

• Creatinine less than 1.5 times normal

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use a highly effective method of contraception for female patients or barrier contraception for male patients

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No other concurrent anticancer chemotherapy

Endocrine therapy:

• Concurrent corticosteroid therapy for increased intracranial pressure allowed

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No concurrent cytochrome P450-inducing anticonvulsants (e.g., phenytoin or carbamazepine) during paclitaxel therapy

• Other concurrent anticonvulsants (e.g., valproic acid) for pre-existing seizure disorder allowed