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

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

Summary

Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as motexafin gadolinium may make the tumor cells more sensitive to radiation therapy. Phase I trial to study the effectiveness of motexafin gadolinium plus radiation therapy in treating children who have newly diagnosed brain stem glioma

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Motexafin gadolinium

Criteria

Inclusion Criteria:

• Clinically and radiographically (MRI) proven newly diagnosed diffuse intrinsic brainstem glioma

• Greater than 50% intra-axial involvement of the pons, pons and medulla, pons and midbrain, or entire brainstem

• Contiguous involvement of the thalamus or upper cervical cord allowed

• Performance status - ECOG 0-2

• More than 2 months

• Absolute neutrophil count at least 1,000/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 10.0 g/dL (transfusion allowed)

• No glucose 6 phosphate dehydrogenase deficiency

• Bilirubin no greater than 1.5 times normal

• SGOT or SGPT less than 1.5 times normal

• Creatinine no greater than 1.5 times normal

• Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No concurrent immunomodulating agents

• No other concurrent chemotherapy

• Concurrent corticosteroid therapy allowed for increased intracranial pressure only

• No prior cranial radiotherapy

• No prior motexafin gadolinium

• No other concurrent experimental agents