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

This is a Phase I/II clinical trial. Researchers are trying to find out if using
increased-dose intensity modulated proton therapy (IMPT) for treatment of Meningiomas will be
more effective than the current treatment.

The intensity modulated part of IMPT allows for even better concentration of the radiation
dose to the desired target and less dose to the surrounding normal tissues than even
traditional passive scattering proton therapy can do. Proton beams can be regulated to stop
within or shortly beyond treatment targets. Therefore there is little exposure of the normal
tissue to radiation.

The FDA (the U.S. Food and Drug Administration) has not approved IMPT as a treatment for any
disease.

Inclusion Criteria:

- Participants must have either:

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

OR

- histologically confirmed malignant/anaplastic meningioma, WHO grade III with any prior
surgery.

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 to be
teratogenic. For this reason, women of child-bearing potential and all men must agree
to use adequate contraception (hormonal or barrier method of birth control;
abstinence) prior to study entry and for the duration of study participation. Should a
woman become pregnant or suspect she is pregnant while she or her partner is
participating in this study, she should inform her treating physician immediately. Men
treated or enrolled on this protocol must also agree to use adequate contraception
prior to the study, for the duration of study participation, and 4 months after
completion of proton therapy.

- Ability to understand and the willingness to sign a written informed consent document.

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 active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

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

- Individuals with a history of a different malignancy are ineligible except for the
following circumstances. Individuals with a history of other malignancies are eligible
if they have been disease-free for at least 3 years and are deemed by the investigator
to be at low risk for recurrence of that malignancy. Individuals with the 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.