Using advanced proton therapy to treat pediatric ependymoma
Pilot Trial of LET Optimized IMPT for Pediatric Patients With Ependymoma
This study is testing a new type of proton therapy for children with ependymoma to see if it safely targets tumors while protecting healthy tissue and improving their outcomes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | N/A to 22 Years |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT03750513 on ClinicalTrials.gov |
What this trial studies
This phase I trial investigates the safety and effectiveness of linear energy transfer (LET) optimized image modulated proton therapy (IMPT) in pediatric patients diagnosed with ependymoma. The study aims to evaluate the side effects of this innovative radiation therapy, which utilizes proton beams to target tumor cells while minimizing damage to surrounding healthy tissues. Additionally, advanced imaging techniques will be employed to identify biomarkers that reflect changes in the tumor and assess the treatment's impact on patient outcomes. Patients will receive treatment over a period of up to six weeks, followed by regular follow-ups to monitor their progress.
Who should consider this trial
Good fit: Ideal candidates include pediatric patients with confirmed ependymoma confined to the brain and who meet specific health criteria.
Not a fit: Patients with disseminated ependymoma or those who have previously received radiation therapy to the brain may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes and reduced side effects for children with ependymoma.
How similar studies have performed: While this approach is innovative, similar studies using advanced proton therapy techniques have shown promise in treating various cancers, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Previous pathologic confirmation of ependymoma, World Health Organization (WHO) grade II or III * Disease must be confined to the brain (no evidence of spread on MR imaging of the spine or on staging lumbar puncture) * Patient may not receive chemotherapy concurrent with radiation * Signed informed consent by patient and/or parents or legal guardian * Lansky performance status score of 50 -100 Exclusion Criteria: * Patients with previous radiation therapy to the brain * Ependymoma of the spine * Disseminated ependymoma requiring craniospinal radiation therapy * Pregnancy * Inability to undergo MR imaging * Inability to receive gadolinium-based contrast agent
Where this trial is running
Boston, Massachusetts and 1 other locations
- Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States (Not_yet_recruiting)
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: David R Grosshans — M.D. Anderson Cancer Center
- Study coordinator: David Grosshans
- Email: dgrossha@mdanderson.org
- Phone: 713-563-2300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.