Motexafin Gadolinium Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
Completed · Phase 1
Conditions studied: Untreated Childhood Brain Stem Glioma
In brief
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
Key facts
- Study ID
- NCT00003909
- Run by
- National Cancer Institute (NCI)
- People needed
- 24
- Starts
- 1999-08-01
- Last updated by the study team
- 2013-01-16
Who can join
Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Children's Oncology Group — Arcadia, California, United States
Full record on ClinicalTrials.gov
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