Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as carboplatin and lobradimil may make the tumor cells more sensitive to radiation therapy.

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

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

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin

Criteria

DISEASE CHARACTERISTICS:

• Newly diagnosed diffuse, intrinsic brain stem gliomas

• Measurable disease

• No disseminated disease at sites other than brain stem

• No neurofibromatosis

• Treatment must begin within 31 days of diagnosis

• Date of diagnosis will be considered date of surgery in patients undergoing surgical biopsy

PATIENT CHARACTERISTICS:

Age:

• 3 to 21

Performance status:

• Karnofsky 50-100% (over 10 years of age)

• Lansky 50-100% (10 years of age and under)

Life expectancy:

• At least 2 months

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)

• SGPT no greater than 2.5 times ULN (4.0 times ULN with antiepileptic or steroid medications)

Renal:

• Creatinine less than ULN for age OR

• Creatinine clearance or glomerular filtration rate greater than 80 mL/min

Other:

• No history of severe allergic reaction to any platinum-containing compound

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent growth factors during therapy with carboplatin

Chemotherapy

• Not specified

Endocrine therapy

• Prior corticosteroids for brain stem glioma are allowed

Radiotherapy

• Not specified

Surgery

• Prior surgery for brain stem glioma is allowed

Other

• At least 24 hours since any of the following medications:

• Vasodilating compounds

• Angiotensin-converting enzyme inhibitors

• Calcium channel blockers

• Beta blockers

• No other prior therapy for brain stem glioma