Increased Dose IMPT in Treating Patients with High-Grade Meningiomas
This phase I trial studies the side effects and best dose of intensity modulated proton therapy (IMPT) and to see how well it works in treating patients with high-grade meningiomas. IMPT uses high energy protons to kill cancer cells and shrink tumors while reducing the exposure of surrounding normal tissue to radiation.
Inclusion Criteria
- Histologically confirmed atypical meningioma, World Health Organization (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 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 have neurofibromatosis type 1 or 2
- Participants may have received prior cranial irradiation
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky performance status >= 60)
- 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
- 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02693990.
PRIMARY OBJECTIVE:
I. To assess safety and to characterize the potential radiation-associated normal tissue toxicity during and after increased-dose IMPT in patients with atypical and malignant meningiomas.
SECONDARY OBJECTIVES:
I. To assess local tumor control with increased-dose IMPT in patients with atypical and malignant meningiomas.
II. To document overall survival rates after increased-dose IMPT in patients with atypical and malignant meningiomas.
III. To assess for potential biomarker correlates of response to radiation treatment, radiation sensitivity, and associated adverse effects, including assessment of white blood cell counts (including leukocytes, lymphocytes, CD4 counts, macrophages, and monocytes) and inflammatory markers (circulating cytokines) that may be affected by radiation therapy.
IV. To prospectively assess the correlation between radiographic changes and linear energy transfer (LET) as well as correlation between physical and relative biological effectiveness (RBE)-weighted dose with tumor control and toxicities.
V. To explore the potential of prompt gamma-ray spectroscopy for real-time monitoring of the range of the delivered proton beams.
OUTLINE: This is a dose-escalation study of IMPT.
Patients undergo IMPT with simultaneous integrated boost (SIB) 5 days per week for 6.5-7 weeks in the absence of disease progression or unacceptable toxicity. Starting and reduced doses will be dependent on histology and resection status.
After completion of study treatment, patients are followed up at 3, 6, 12, 24, and 36 months and then annually for up to 5 years.
Trial PhasePhase I
Trial Typetreatment
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorHelen A Shih
- Primary ID15-542
- Secondary IDsNCI-2016-00702
- ClinicalTrials.gov IDNCT02693990