Clinical trial · Interventional
Motexafin Gadolinium Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
A Phase I Study of Motexafin Gadolinium (Xcytrin, NSC 695238) and Involved Field Radiation Therapy for Intrinsic Pontine Glioma of Childhood
NCT00003909CI-TRIAL-00008924completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
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
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| motexafin gadolinium | Drug | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Approximately 2-5 hours before radiotherapy, patients receive motexafin gadolinium IV over 5 minutes. Patients undergo radiotherapy 5 days a week for 6 weeks.
- interventionNames
- Drug: motexafin gadolinium
- Radiation: radiation therapy
- Other: pharmacological study
Primary outcomes (1)
- measure
- MTD defined as the dose at which fewer than one-third of patients experience DLT assessed using CTC version 2.0
- timeFrame
- 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.