NovoTTF-200A and Temozolomide Chemoradiation for Newly Diagnosed Glioblastoma

Launched by HACKENSACK MERIDIAN HEALTH · Jul 26, 2017

Keywords

ClinConnect Summary

A prospective, single arm, non-randomized, open label pilot trial will enroll ten patients with histologically-confirmed newly diagnosed GBM who meet all eligibility criteria. Patients will be recruited to the study by the principal investigator (PI) or one of the co-investigators (CI) at one institution, Hackensack University Medical Center. Accrual is expected to continue for 18 months.

The protocol has a planned enrollment of 10 patients. Should patients discontinue treatment on protocol for reasons unrelated to toxicity (e.g. lost to follow-up, withdrawal of consent), additional patien...

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Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically confirmed GBM using WHO criteria.
• • 2. Age ≥ 18 years
• • 3. Maximal debulking surgery (at the discretion of the investigator). Biopsy alone is not exclusionary.
• • 4. KPS ≥ 70
• • 5. Life expectancy of at least 3 months.
• • 6. Sexually active participants must agree to the strict use of barrier contraception.
• • 7. Patients must be able to understand the investigational nature of the study and provide informed consent.
• 8. Adequate hematologic function:
• • 1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• • 2. Platelet count ) ≥ 100 x 109/L
• • 3. Hemoglobin ≥ 10 g /dL
• • 9. Adequate liver function
• • 1. Total bilirubin ≤ 1.5 x ULN
• • 2. AST and ALT ≤ 2.5 x ULN
• • 10. Adequate renal function
• • a. Creatinine ≤ 1.25 x ULN
• • 11. International normalized ratio (INR) or PT and activated partial thromboplastin time (aPTT): 1.5 x ULN (except for subjects receiving anticoagulation therapy). Use of anticoagulants is permitted as long as the INR or aPTT are within therapeutic limits (according to the medical standard of the institution).
• Exclusion Criteria:
• • 1. Active participation in another clinical treatment trial. Concomitant protocols for data or tissue collection without intervention are permitted.
• • 2. Any prior treatment for GBM aside from surgery, including carmustine wafers.
• • 3. Women who are pregnant or nursing.
• 4. Severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation, NovoTTF-200A device use or interfere with interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into the trial. This includes but not limited to:
• • 1. Patients with inadequately healed surgical incisions or other dermatologic scalp toxicity at baseline (grade 2 or higher, as defined in Section VIII) upon which transducer leads may require placement.
• • 2. Known HIV or other immunosuppressive disease, chronic hepatitis B or hepatitis C
• • 3. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of the protocol.
• • 5. Implanted pacemaker, programmable shunt, cardiac defibrillator, deep brain stimulator, other implanted electronic devices in the brain or documented clinically significant arrhythmias.
• • 6. Infratentorial glioblastoma.
• • 7. Past hypersensitivity reaction to temozolomide or DTIC.
• • 8. Psychiatric illness that compromises the informed consent process, at the discretion of the investigator.
• • 9. Inability or unwillingness to return for required visits.
• • 10. Previous cytotoxic therapy within the last 5 years.
• • 11. Inability to begin temozolomide concomitant to radiation therapy, for reasons 4 or 7 above.