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

NCT02693990 | Active Not Recruiting DMC

• 2 other identifiers: 15-5422U19CA021239-36
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief 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)

Conditions

Meningioma; Brain Tumor

Keywords

Tumor lining the brain; Meningioma; Brain Tumor

Outcome Measures

Primary Outcomes (1)

• Assess Safety and Utility of Increased Dose IMPT: Dose-limiting toxicity (DLT) using NCI CTC 4.0

  Establish a safe increased-dose of post-operative IMPT with SIB in treating each of two meningioma cohorts: grade II (atypical) with subtotal resection and grade III (malignant) with gross total resection. Dose-limiting toxicity (DLT) using NCI CTC 4.0 will be assessed from the start of protocol treatment. The dose-seeking plan for each meningioma cohort will follow a modified 3+3 design with the starting and reduced doses for CTV and GTV.

  2 years

Secondary Outcomes (3)

• The Absence of Progressive or Recurrent Disease

  5 years

• Overall Survival

  2 years

• Calculate Linear Energy Transfer Using Computer Simulations Based on the Treatment Plan

  2 years

Other Outcomes (1)

• In Vivo Range of the Delivered Proton Pencil-Beams

  2 years

Study Arms (2)

Grade II (Atypical) Meningiomas, STR

EXPERIMENTAL

Patient will be treated at the starting dose of Intensity Modulated Proton Therapy (IMPT) which is pre-determined.

Radiation: Intensity Modulated Proton Therapy (IMPT)

Grade III (Malignant) Meningiomas, GTR

EXPERIMENTAL

Patient will be treated at a pre determined dose of Intensity Modulated Proton Therapy (IMPT) for the specific cohort.

Radiation: Intensity Modulated Proton Therapy (IMPT)

Interventions

Intensity Modulated Proton Therapy (IMPT) RADIATION

Radiation Therapy - Intensity Modulated Proton Therapy (IMPT)

Grade II (Atypical) Meningiomas, STR; Grade III (Malignant) Meningiomas, GTR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have either:
• histologically confirmed atypical meningioma, WHO grade II, Simpson grade 4-5 that has been either subtotally resected or biopsied.
• histologically confirmed malignant/anaplastic meningioma, WHO grade III with gross total 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Meningioma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases

Study Officials

• Helen A Shih, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Radiation Oncologist

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: February 29, 2016
• Study Start: February 1, 2016
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (2)