Clinical trial · Interventional
Motexafin Gadolinium and Radiation Therapy in Treating Young Patients With Pontine Glioma
A Phase II Study of Motexafin-Gadolinium (NSC 695238, IND #55583) and Involved Field Radiation Therapy for Intrinsic Pontine Glioma of Childhood
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Untreated Childhood Brain Stem Glioma | Childhood Brain Stem Glioma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-dimensional conformal radiation therapy | Radiation | — | UNRESOLVED |
| motexafin gadolinium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo focal cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: motexafin gadolinium
- Radiation: 3-dimensional conformal radiation therapy
Primary outcomes (1)
- measure
- One Year Event-free Survival (EFS)
- timeFrame
- One year after enrollment.
- description
- Percentage probability of being event-free at 1 year following enrollment.
Secondary outcomes (2)
- measure
- Overall Survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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 chemotherapy * No concurrent immunomodulating agents
References
Publications (0)
Data not yet available