Summary

This clinical trial tests the safety and side effects of tumor treating fields in treating patients with glioma. Optune is a wearable, portable, treatment that creates low-intensity, wave-like electric fields called tumor treating fields (TTFields), which interfere with cancer cell division. Tumor treating fields may help shrink tumors in patients with glioma.

Objectives

PRIMARY OBJECTIVE:
I. To evaluate the safety and tolerability of tumor treating fields in combination with standard of care radiotherapy and chemotherapy in patients with brainstem gliomas.

SECONDARY OBJECTIVE:
I. To evaluate the anti-tumor activity of the combination of radiotherapy, chemotherapy, and tumor treating fields by assessing progression-free survival (PFS), overall response rate, and overall survival (OS).

TERTIARY/EXPLORATORY OBJECTIVE:
I. To assess the effects of the tumor treating fields on neurocognitive function.

OUTLINE:
Beginning after start of standard of care radiation therapy, patients wear the Optune device for 18 hours per day for 12 months in the absence of disease progression or unacceptable toxicity.

Eligibility

1. Age >= 18 years
2. Karnofsky performance status >= 70%
3. Life expectancy > 12 weeks as determined by the investigator
4. Diagnosis of glioma with at least partial involvement or invasion of thalamus, cerebral peduncles, midbrain, pons, or medulla. Confirmation of diagnosis by biopsy or maximal safe resection preferred. If multi-disciplinary tumor board recommend no benefit and likely harm of attempting biopsy then can establish consensus clinical diagnosis. If foregoing biopsy then tumor board will estimate tumor stage based on clinical presentation and radiographic findings
5. Hemoglobin >= 9.0 g/dl (no transfusions allowed within 7 days of cycle 1 day 1 to meet entry criteria) (within 28 days of cycle 1 day 1 of temozolomide)
6. White blood cell (WBC) >= 2000/uL (after at least 7 days without growth factor support or transfusion) (within 28 days of cycle 1 day 1 of temozolomide)
7. Absolute neutrophil count (ANC) >= 1,500/mcL (after at least 7 days without growth factor support or transfusion) (within 28 days of cycle 1 day 1 of temozolomide)
8. Platelets >= 100,000/mcL (no transfusions allowed within 7 days of cycle 1 day 1 to meet entry criteria) (within 28 days of cycle 1 day 1 of temozolomide)
9. Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) (within 28 days of cycle 1 day 1 of temozolomide)
10. Total bilirubin =< 2 institutional upper limit of normal (ULN) (within 28 days of cycle 1 day 1 of temozolomide)
11. Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 institutional upper limit of normal (ULN) (within 28 days of cycle 1 day 1 of temozolomide)
12. Serum creatinine =< 2 mg/dL (or glomerular filtration rate >= 40 mL/min) (within 28 days of cycle 1 day 1 of temozolomide)
13. Lipase and amylase =< 1.5 x ULN (< 3 x ULN if subject with pancreatic metastases) (within 28 days of cycle 1 day 1 of temozolomide)
14. Electrocardiogram QT interval corrected by Fridericia's formula (QTcF) < 450 ms (average of 3 readings approximately 2 minutes apart) (within 28 days of cycle 1 day 1 of temozolomide)
15. Echocardiogram documented left ventricular ejection fraction > 45% within 60 days prior to cycle 1 (C1) day 1 (within 28 days of cycle 1 day 1 of temozolomide)
16. The effects of combination therapy with tumor treating fields (TTF) and temozolomide on the developing human fetus are unknown. For this reason and because other therapies used in this trial are known to be teratogenic, female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy
17. FCBP and 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 12 months after completion of TTF and temozolomide administration. A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months
18. Completion of all previous therapy (including surgery and radiotherapy or chemoradiotherapy) for the treatment of cancer >= 4 weeks before the start of study therapy
19. Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions
20. Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation

Treatment Sites in Georgia