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Proton Therapy for Craniopharyngioma

Phase 2

Waitlist Available

Led By Thomas E Merchant, DO, PhD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Craniopharyngioma diagnosed by histology, cytology, or neuroimaging

Patients ages 0-21 years at the time of diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is designed to test whether proton therapy is a safe and feasible treatment for patients with a brain tumor known as craniopharyngioma.

Who is the study for?

This trial is for individuals aged 0-21 years diagnosed with craniopharyngioma, confirmed through tissue samples or imaging. It's not open to pregnant females due to radiation risks, nor those who've had prior fractionated radiation therapy, intracystic P-32 treatment, bleomycin or radiosurgery.Check my eligibility

What is being tested?

The study tests limited surgery followed by proton therapy on patients with craniopharyngioma who haven't undergone radical surgery. Proton therapy involves 30 sessions over six weeks with weekly imaging to monitor the brain tumor's response.See study design

What are the potential side effects?

Proton therapy may cause fatigue, headaches, hair loss at the treatment site, skin irritation similar to sunburns around the treated area and potential short-term memory issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with craniopharyngioma.

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I was diagnosed with my condition before turning 22.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Estimate the progression-free and overall survival distributions for children and young adults with craniopharyngioma treated with limited surgery and proton therapy

Secondary outcome measures

Estimate the cumulative incidence of cystic intervention and the event-free survival distribution for children and young adults with craniopharyngioma treated with limited surgery and proton therapy

Estimate the distributions of progression-free survival and overall survival for children and young adults with craniopharyngioma treated only with primary surgical resection

Trial Design

1Treatment groups

Experimental Treatment

Group I: Craniopharyngioma PatientsExperimental Treatment4 Interventions

Craniopharyngioma patients will have limited surgery and a 5mm clinical target volume margin in combination with proton therapy. Proton therapy will be indicated for patients with diagnosed craniopharyngioma who are not treated with radical surgery (gross-total resection). Patients who have had radical surgery or limited surgery prior to enrollment on this study and have no evidence of tumor will be observed for 5 years. Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine will be given to aid in tumor visualization.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Proton Therapy

2009

Completed Phase 2

~280

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor

427 Previous Clinical Trials

5,306,465 Total Patients Enrolled

4 Trials studying Craniopharyngioma

865 Patients Enrolled for Craniopharyngioma

Thomas E Merchant, DO, PhDPrincipal InvestigatorSt. Jude Children's Research Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients still being enrolled in this trial?

"According to clinicaltrials.gov, this particular trial is not currently seeking patients after last being updated on 9/23/2022. Though there are 16 other trials that may be of interest and are actively recruiting participants."

Answered by AI

What are the odds of experiencing negative side effects from this medication?

"As this is a Phase 2 trial, meaning that while there are some data supporting safety, none yet support efficacy, our team at Power has given it a score of 2."

Answered by AI

Could you share if this therapy has been explored before in other research?

"At the moment, there are five active clinical trials researching this intervention. Of these ongoing studies, none have reached Phase 3 yet. The majority of research for this treatment is based in Toronto and Tennessee; however, there are a dozen locations running these sorts of tests."

Answered by AI

Have there been other trials like this one before?

"There are 5 on-going trials for this intervention in 3 metropolises and 3 countries. The first trial began in 2007. Sponsored by Baxter Healthcare Corporation, the Phase 4 drug approval stage involved 4640 individuals and was completed successfully. In the 14 years since then, 21 more research studies have been carried out."

Answered by AI

How many individuals are being given this medication as part of the research project?

"Unfortunately, this particular study is not enrolling new patients at the moment. It was originally posted on August 22nd, 2011 and updated September 23rd, 2022. Although this trial isn't currently running, there are 11 other similar trials recruiting participants with craniopharyngioma and 5 clinical trials for this treatment that are actively looking for volunteers."

Answered by AI

Recent research and studies

Physics in Medicine & BiologyJournal

Proton Therapy Delivery Method Affects Dose-averaged Linear Energy Transfer in Patients

Wilson, Lydia J, Fakhriddin Pirlepesov, Vadim Moskvin, Zuofeng Li, Yian Guo, Yimei Li, Thomas E Merchant, and Austin M Faught. 2021. “Proton Therapy Delivery Method Affects Dose-averaged Linear Energy Transfer in Patients”. Physics in Medicine & Biology. IOP Publishing. doi:10.1088/1361-6560/abe835.

clinicaltrials.govStudy

A Phase II Trial of Limited Surgery and Proton Therapy for Craniopharyngioma or Observation After Radical Resection

2011. "A Phase II Trial of Limited Surgery and Proton Therapy for Craniopharyngioma or Observation After Radical Resection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01419067.

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