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

  • STATUS
    Recruiting
  • End date
    Aug 25, 2027
  • participants needed
    60
  • sponsor
    Massachusetts General Hospital
Updated on 23 February 2022
meningioma
karnofsky performance status
proton therapy
malignant meningioma
atypical meningioma

Summary

This research study is studying radiation therapy as a possible treatment for meningioma or tumor on the lining of the brain. The study drug or intervention involved in this research study is Intensity Modulated Proton Therapy (IMPT)

Description

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.

Details
Condition Meningioma, Brain Tumor
Treatment Intensity Modulated Proton Therapy (IMPT)
Clinical Study IdentifierNCT02693990
SponsorMassachusetts General Hospital
Last Modified on23 February 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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