A Trial of Increased Dose Intensity Modulated Proton Therapy (IMPT) for High-Grade Meningiomas

Inclusion Criteria:

• Participants must have either:

• histologically confirmed atypical meningioma, WHO grade II, Simpson grade 4-5that has been either subtotally resected or biopsied.

OR

• histologically confirmed malignant/anaplastic meningioma, WHO grade III with grosstotal resection.

In the case of recurrent radiographically gross disease, pathologic diagnosis may be from time of original biopsy and/or surgery. Pathology should be reviewed and confirmed at the Participating Institution.

Patients may or may not have neurofibromatosis type 1 or 2.

• Age 18 years or older.

• ECOG performance status ≤ 2 (Karnofsky Performance Status ≥ 60, see Appendix A)

• The effects of proton radiation therapy on the developing human fetus are known tobe teratogenic. For this reason, women of child-bearing potential and all men mustagree to use adequate contraception (hormonal or barrier method of birth control;abstinence) prior to study entry and for the duration of study participation. Shoulda woman become pregnant or suspect she is pregnant while she or her partner isparticipating in this study, she should inform her treating physician immediately.Men treated or enrolled on this protocol must also agree to use adequatecontraception prior to the study, for the duration of study participation, and 4months after completion of proton therapy.

• Ability to understand and the willingness to sign a written informed consentdocument.

Exclusion Criteria:

• Participants may not be receiving any other investigational agents.

• Participants may not have received prior cranial irradiation.

• Uncontrolled intercurrent illness including, but not limited to ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith study requirements.

• Pregnant or lactating women are excluded from this study because radiation is knownto have teratogenic or abortifacient effects. Because there is an unknown butpotential risk of adverse events in nursing infants secondary to treatment of themother with radiation therapy, breastfeeding should be discontinued if the mother istreated with radiation therapy.

• Individuals with a history of a different malignancy are ineligible except for thefollowing circumstances. Individuals with a history of other malignancies areeligible if they have been disease-free for at least 3 years and are deemed by theinvestigator to be at low risk for recurrence of that malignancy. Individuals withthe following cancers are eligible if diagnosed and treated within the past 3 years:cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.