Status:
COMPLETED
NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
NovoCure Ltd.
Conditions:
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Eligibility:
All Genders
22+ years
Phase:
PHASE2
Brief Summary
NovoTTF-100A is a device and Bevacizumab is a study drug that have both been approved by the FDA (Food and Drug Administration) for use as monotherapy in treating glioblastoma multiforme. The NovoTTF-...
Detailed Description
This will be an open label Phase II trial in adults with recurrent glioblastoma (GBM). The NovoTTF-100A treatment and Bevacizumab will be administered on an outpatient basis; NovoTTF-100A treatment wi...
Eligibility Criteria
Inclusion
- Patients with histologically confirmed glioblastoma or other grade IV malignant glioma (i.e. gliosarcoma, small cell glioblastoma, etc.), recurrent after prior external-beam fractionated radiotherapy and temozolomide chemotherapy.
- Patients with up to two prior recurrences are allowed.
- Karnofsky performance status ≥70.
- Patients must have the following laboratory values:
- Absolute neutrophil count (ANC) ≥1.5 x 10\^9/L
- Platelets ≥ 100 x 10\^9/L
- Hemoglobin (Hgb) \> 9 g/dL
- Serum total bilirubin: ≤ 1.5 x ULN
- ALT and AST ≤ 3.0 x ULN
- Serum creatinine ≤ 1.5 x ULN
- Blood coagulation parameters: INR ≤ 1.5
- Minimum interval since completion of radiation treatment is 12 weeks
- Minimum interval since last drug therapy:
- 3 weeks since last non-cytotoxic therapy
- 3 weeks must have elapsed since the completion of a non-nitrosourea-containing chemotherapy regimen
- 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen.
- Patients must have signed an approved informed consent and authorization permitting release of personal health information.
- Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. The effects of bevacizumab on developing fetus or nursing infant are not known. Female patients of child-bearing potential must have a negative pregnancy test.
- Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast, adequately treated stage I or II cancer from which the patient is in complete remission. Patients with other prior malignancies must be disease-free for ≥ three years.
- Patients must be maintained on a stable corticosteroid regimen from the time of their baseline scan until the start of treatment and/or for at least 5 days before starting treatment.
Exclusion
- Patients who have had previous treatment with bevacizumab, and or NovoTTF 100A system.
- Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury
- Patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- History or presence of serious uncontrolled ventricular arrhythmias
- Any of the following within 6 months prior to starting study drug: myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE)
- Uncontrolled hypertension (defined by a systolic blood pressure (SBP) ≥ 160 mm Hg or diastolic blood pressure (DBP) ≥ 100 mm Hg while on anti-hypertensive medications)
- Patients with cirrhosis, or active viral or nonviral hepatitis.
- Implanted pacemaker, defibrillator or deep brain stimulator, other implanted electronic devices in the brain or documented clinically significant arrhythmias.
- Infra-tentorial tumor
- Evidence of increased intracranial pressure (clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
- Known sensitivity to conductive hydrogels
- Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)
- Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol
- Pregnant or breast-feeding women
- Patients unwilling or unable to comply with the protocol
- Patients with leptomeningeal disease
Key Trial Info
Start Date :
September 18 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01894061
Start Date
September 18 2013
End Date
July 1 2019
Last Update
February 17 2025
Active Locations (3)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45220
2
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
3
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195