Motexafin Gadolinium and Radiation Therapy in Treating Young Patients With Pontine Glioma (NCT00387790) | Clinical Trial Compass
CompletedPhase 2
Motexafin Gadolinium and Radiation Therapy in Treating Young Patients With Pontine Glioma
United States64 participantsStarted 2007-06
Plain-language summary
This phase II trial is studying how well giving motexafin gadolinium together with radiation therapy works in treating young patients with pontine glioma. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as motexafin gadolinium, may make tumor cells more sensitive to radiation therapy. Giving motexafin gadolinium together with radiation therapy may kill more tumor cells.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of intrinsic pontine glioma (brain stem glioma)
* Clinical and radiographic (MRI) evidence of tumors that diffusely involve the brain stem (i.e., tumors that intrinsically \[\> 50% intra-axial\] involve the pons or pons and medulla, pons and midbrain, or entire brain stem) allowed
* Tumor may contiguously involve the thalamus or upper cervical cord
* No more than 1 lesion/mass present at diagnosis
* Karnofsky performance status (PS) 60-100% (age \> 16 years) OR Lansky PS 60-100% (age ≤ 16 years)
* Life expectancy ≥ 8 weeks
* Absolute neutrophil count ≥ 1,000/mm³
* Platelet count ≥ 100,000/mm³ (transfusion independent)
* Hemoglobin ≥ 10 g/dL (RBC transfusions allowed)
* Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine normal for age/gender (0.4-1.7 mg/dL)
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT \< 1.5 times ULN
* No known glucose-6-phosphate dehydrogenase (G6PD) deficiency
* If family history suggestive of congenital hemolytic anemia, patient must be screened for G6PD with G6PD activity test prior to study entry
* No biliary obstruction
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior definitive therapy for this specific tumor
* No prior cranial radiotherapy
* Concurrent steroids and anticonvulsants allowed
* No concurrent proton therapy
* No concurrent intensity-modulated radiotherapy
* No concurrent anticancer…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.