Proton Therapy for Craniopharyngioma

Recruiting in Palo Alto (17 mi)

Overseen by Thomas Merchant

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: St. Jude Children's Research Hospital

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Craniopharyngioma is a rare brain tumor that affects both children and adults. It arises in a region of the brain near the pituitary gland, visual pathways, and central blood vessels. Patients often present with headache, loss of vision or delayed growth. In some instances they may present with imbalance of water and salts in the body. The treatment for craniopharyngioma may be radical surgery or a combination of surgery and radiation therapy. In some instances surgery is not required. If the tumor cannot be completely removed, radiation therapy may be required. In this study we will use the most advanced form of proton therapy which is called intensity-modulated proton therapy. This is a newer form of radiation therapy which has a number of advantages over older forms of proton therapy and conventional radiation therapy using x-rays. The main goal of this study is to learn if proton therapy will effectively treat patients with craniopharyngioma brain tumors and reduce side effects compared to more traditional forms of radiation therapy.

Research Team

Thomas Merchant

Principal Investigator

St. Jude Children's Research Hospital

Eligibility Criteria

This trial is for individuals aged 0-21 diagnosed with craniopharyngioma, a rare brain tumor. It's open to those who have not had complete surgical removal of the tumor or require observation after radical surgery. Pregnant females and patients previously treated with certain intracystic therapies or radiation are excluded.

Inclusion Criteria

I was diagnosed with my condition before turning 22.

My diagnosis of craniopharyngioma was confirmed through tests or surgery.

Exclusion Criteria

I have had treatment with P-32 or bleomycin directly into a cyst.

I have had radiation therapy in parts before.

Pregnant females are excluded due to the teratogenic or abortifacient effects of radiation.

Treatment Details

Interventions

• Intensity-Modulated Proton Therapy (Proton Beam Therapy)
• Surgery (Procedure)

Trial Overview The study tests intensity-modulated proton therapy (IMPT) for treating craniopharyngioma when surgery doesn't remove all of the tumor, aiming to see if IMPT can be more effective and cause fewer side effects than traditional radiation treatments.

Participant Groups

Group I: Tumor-Surgery Active Control 2 Interventions

Participants who are eligible to undergo surgery to remove the tumor will proceed to surgery. If all tumor is removed, they will be followed over 5 years for outcome comparison to the other participant groups. If the entire tumor is not removed by surgery, participants will receive 6 weeks of proton therapy. They will then be followed for 5 years to collect outcome data for comparison to the other participant groups.

Group II: Tumor-No Surgery Active Control 1 Intervention

Participants whose tumor cannot be resected through surgery will receive 6 weeks of proton therapy. They will then be followed over 5 years for outcome comparison to the other participant groups.

Intensity-Modulated Proton Therapy is already approved in Canada, Japan for the following indications:

Approved in Canada as IMPT for:

• Head and neck cancers
• Squamous cell carcinoma
• Nasopharyngeal cancer
• Oropharyngeal cancer
• Thyroid cancer
• Salivary gland cancer

Approved in Japan as IMPT for:

• Head and neck cancers
• Squamous cell carcinoma
• Nasopharyngeal cancer
• Oropharyngeal cancer
• Thyroid cancer
• Salivary gland cancer

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

Dr. James R. Downing

St. Jude Children's Research Hospital

Chief Executive Officer since 2014

MD from University of Michigan Medical School

Dr. Ellis J. Neufeld

St. Jude Children's Research Hospital

Chief Medical Officer since 2017

MD, PhD from Harvard Medical School