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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

Must not have

Prior treatment with intracystic P-32, intracystic bleomycin, or radiosurgery

Prior history of fractionated radiation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had treatment with P-32, bleomycin, or radiosurgery for a cyst.

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I have had radiation therapy in parts before.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2013

Completed Phase 2

~320

0 / 4Eligibility criteria met