Clinical Trial - NCT02693990

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

Recruiting

Sponsor: Massachusetts General Hospital

Collaborators: National Cancer Institute (NCI)

Information provided by (Responsible party): Principal Investigator Massachusetts General Hospital Helen A. Shih, MD Attending Radiation Oncologist

ClinicalTrials.gov Identifier: NCT02693990

Protocol Info

Short Description: Phase I/II Trial of Increased Dose IMPT for High-Grade Meningiomas
Long Description: A Phase I/II Trial of Increased Dose Intensity Modulated Proton Therapy (IMPT) for High-Grade Meningiomas
MGH Status: Open
Sponsor: DF/HCC
Disease Program: Proton

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

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)
Condition Title Intervention Phase
Meningioma Brain Tumor Intensity Modulated Proton Therapy (IMPT) N/A
Study Type Interventional
Official Title A Phase I/II Trial of Increased Dose Intensity Modulated Proton Therapy (IMPT) for High-Grade Meningiomas

Primary Outcome Measures

Assess Safety and Utility of Increased Dose IMPT: Dose-limiting toxicity (DLT) using NCI CTC 4.0 [Time Frame: 2 years] [Designated as safety issue: ]


Secondary Outcome Measures

The Absence of Progressive or Recurrent Disease [Time Frame: 5 years] [Designated as safety issue: ]

Overall Survival [Time Frame: 2 years] [Designated as safety issue: ]

Calculate Linear Energy Transfer Using Computer Simulations Based on the Treatment Plan [Time Frame: 2 years] [Designated as safety issue: ]

Estimated Enrollment: 60
Study Start Date: February 2016
Estimated Study Completion Date: February 2024
Estimated Primary Completion Date: February 2020
Arms Assigned Interventions

Experimental:Grade II (Atypical) Meningiomas, STR

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

Experimental:Grade III (Malignant) Meningiomas, GTR

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

Experimental:Grade III (Malignant) Meningiomas, STR

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

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02693990

Locations

  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114
  • United States, Texas
    • MD Anderson Cancer Center Houston, Texas, United States, 77030

Sponsors and Collaborators

Massachusetts General Hospital

National Cancer Institute (NCI)

More Information

No publications provided

Responsible Party: Principal Investigator Massachusetts General Hospital Helen A. Shih, MD Attending Radiation Oncologist
ClinicalTrials.gov Identifier: NCT02693990
Other Study ID Numbers: 2U19CA021239-36
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Massachusetts General Hospital:

Tumor lining the brain

Meningioma

Brain Tumor

Additional relevant MeSH terms:

Brain Neoplasms

Meningioma

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on May 30, 2019