- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01894061
NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma
A Prospective Phase II Trial of NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma
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-l00A is a portable battery operated device which produces TTFields within the human body using surface electrodes (transducer arrays). Intermediate frequency electric fields (TTFields) stunt the growth of tumor cells.
The purpose of this study is to determine the efficacy of the combination of Bevacizumab and NovoTTF-100A in Bevacizumab naive (meaning have never received bevacizumab before) patients with recurrent glioblastoma (GBM) as measured by 6-month progression free survival.
Study Overview
Status
Conditions
Intervention / Treatment
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 will be initiated in the outpatient clinic.
PRIMARY OBJECTIVES:
I. To determine the efficacy of the combination of bevacizumab and NovoTTF-100A in bevacizumab-naive patients with recurrent glioblastoma (GBM) as measured by 6-month progression-free survival (PFS6).
SECONDARY OBJECTIVES:
I. To assess safety and tolerability of the combination of bevacizumab and Novo-TTF-100A in this patient population.
II. To evaluate overall survival in this population. III. To determine objective response rate (ORR) by modified Revised Assessment in Neuro-Oncology (RANO) criteria in this population.
IV. To assess time-to-progression in this population. V. To assess neurocognitive function (NCF) and quality of life (QOL) in this population.
OUTLINE:
Patients receive bevacizumab intravenously (IV) on days 1 and 15. Patients also undergo electric field therapy with NovoTTF-100A for at least 18 hours daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for at least 28 days.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45220
- University of Cincinnati
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
-
Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bevacizumab and NovoTTF-100A
Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle.The dose of bevacizumab will be 10 mg/kg of actual body weight.
|
Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle.
The dose of bevacizumab will be 10 mg/kg of actual body weight.
Other Names:
NovoTTF-100A will be worn continuously.
Other Names:
Functional Assessment of Cancer Therapy including Brain Tumor module (FACT-Br) questionnaire
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival (PFS)
Time Frame: 6 months
|
Number of patients that achieve progression free survival by Kaplan Meier methodology.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate based on RANO Criteria
Time Frame: 30 days after treatment completion
|
Response will be scored based on a combination of imaging and clinical features as defined by the modified Response Assessment in Neuro-Oncology (RANO) criteria.
http://www.iconplc.com/services/imaging/central-imaging-core-lab-/regulatory-expertise/IMI-RANO-Criteria-Booklet-Nov-2011.pdf
|
30 days after treatment completion
|
Number of patients that experience toxicities with this combination of therapies
Time Frame: 30 days after treatment completion
|
Safety and tolerability of combination of bevacizumab and NovoTTF-l00A in this population by CTCAE version 4.0.
|
30 days after treatment completion
|
Median overall survival
Time Frame: 30 days after treatment completion
|
30 days after treatment completion
|
|
To assess time-to-progression
Time Frame: 30 days after treatment completion
|
Median time to progression by Kaplan Meier methodology.
|
30 days after treatment completion
|
Neurocognitive function (NCF)
Time Frame: 30 days after treatment completion
|
Time to reliable change (decline) in neurocognitive function by Kaplan Meier methodology.
Memory, verbal fluency, visual-motor speed, executive function and motor dexterity tests will be administered.
|
30 days after treatment completion
|
Quality of Life (QOL)
Time Frame: 30 days after treatment completion
|
Based on the Functional Assessment of Cancer Therapy including Brain Tumor module (FACT-Br) questionnaire
|
30 days after treatment completion
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Manmeet Ahluwalia, MD, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Glioblastoma
- Recurrence
- Brain Neoplasms
- Gliosarcoma
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Antibodies
- Immunoglobulins
- Bevacizumab
- Antibodies, Monoclonal
- Antineoplastic Agents, Immunological
Other Study ID Numbers
- CASE3313
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adult Giant Cell Glioblastoma
-
National Cancer Institute (NCI)CompletedAdult Anaplastic Astrocytoma | Adult Anaplastic Oligodendroglioma | Adult Diffuse Astrocytoma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Adult Mixed Glioma | Adult Pilocytic Astrocytoma | Adult Pineal Gland Astrocytoma | Recurrent Adult Brain Tumor | Adult Subependymal Giant...United States
-
National Cancer Institute (NCI)CompletedAdult Anaplastic Astrocytoma | Adult Giant Cell Glioblastoma | Adult Gliosarcoma | Recurrent Adult Brain TumorUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingAdult Anaplastic Astrocytoma | Adult Anaplastic Ependymoma | Adult Anaplastic Oligodendroglioma | Adult Diffuse Astrocytoma | Adult Ependymoma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Adult Mixed Glioma | Adult Myxopapillary Ependymoma | Adult Oligodendroglioma | Adult Pilocytic... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedAdult Giant Cell Glioblastoma | Adult Glioblastoma | Adult GliosarcomaUnited States
-
National Cancer Institute (NCI)CompletedAdult Giant Cell Glioblastoma | Adult Glioblastoma | Adult GliosarcomaUnited States
-
National Cancer Institute (NCI)TerminatedAdult Giant Cell Glioblastoma | Adult Glioblastoma | Adult GliosarcomaUnited States
-
NRG OncologyNational Cancer Institute (NCI); Radiation Therapy Oncology GroupActive, not recruitingAdult Giant Cell Glioblastoma | Adult Glioblastoma | Adult GliosarcomaUnited States, Canada
-
National Cancer Institute (NCI)CompletedAdult Giant Cell Glioblastoma | Adult Glioblastoma | Adult GliosarcomaUnited States
-
National Cancer Institute (NCI)CompletedAdult Giant Cell Glioblastoma | Adult Glioblastoma | Adult GliosarcomaUnited States
-
National Cancer Institute (NCI)CompletedAdult Giant Cell Glioblastoma | Adult Glioblastoma | Adult GliosarcomaUnited States
Clinical Trials on Bevacizumab
-
National Cancer Institute (NCI)Active, not recruitingRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Ovarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Serous Cystadenocarcinoma | Endometrial Clear Cell Adenocarcinoma | Endometrial Serous Adenocarcinoma | Recurrent... and other conditionsUnited States
-
National Cancer Institute (NCI)NRG OncologyCompletedGlioblastoma | Gliosarcoma | Recurrent Glioblastoma | Oligodendroglioma | Giant Cell Glioblastoma | Recurrent Brain NeoplasmUnited States, Canada
-
M.D. Anderson Cancer CenterRecruitingStage IB Hepatocellular Carcinoma AJCC v8 | Stage II Hepatocellular Carcinoma AJCC v8 | Resectable Hepatocellular Carcinoma | Stage I Hepatocellular Carcinoma AJCC v8 | Stage IA Hepatocellular Carcinoma AJCC v8United States
-
National Cancer Institute (NCI)Active, not recruitingOvarian Endometrioid Adenocarcinoma | Primary Peritoneal High Grade Serous Adenocarcinoma | Fallopian Tube Endometrioid Adenocarcinoma | Platinum-Resistant Fallopian Tube Carcinoma | Platinum-Resistant Primary Peritoneal Carcinoma | Ovarian High Grade Serous Adenocarcinoma | Platinum-Resistant... and other conditionsUnited States, Canada
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)RecruitingRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Clear Cell Adenocarcinoma | Fallopian Tube Adenocarcinoma | Fallopian Tube Serous Adenocarcinoma | Ovarian Serous Adenocarcinoma | Fallopian Tube... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Stage IVA Cervical Cancer AJCC v6 and v7 | Recurrent Cervical Carcinoma | Stage IV Cervical Cancer AJCC v6 and v7 | Stage IVB Cervical Cancer AJCC v6 and v7United States
-
Northwestern UniversityNational Cancer Institute (NCI); Ipsen BiopharmaceuticalsCompletedRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Platinum-Resistant Fallopian Tube Carcinoma | Platinum-Resistant Primary Peritoneal Carcinoma | Platinum-Resistant Ovarian Carcinoma | Refractory Ovarian Carcinoma | Refractory Fallopian Tube... and other conditionsUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); Merck Sharp & Dohme LLC; Celldex TherapeuticsRecruitingRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Recurrent Endometrial Serous Adenocarcinoma | Ovarian Clear Cell Adenocarcinoma | Recurrent Platinum-Resistant Ovarian Carcinoma | Platinum-Sensitive Ovarian Carcinoma | Recurrent Fallopian... and other conditionsUnited States
-
National Cancer Institute (NCI)Active, not recruitingStage IV Cutaneous Melanoma AJCC v6 and v7 | Stage IIIC Cutaneous Melanoma AJCC v7 | Unresectable MelanomaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingMetastatic Lung Non-Small Cell Carcinoma | Stage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage III Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage IIIC Lung Cancer AJCC v8 | Locally Advanced Lung Non-Small... and other conditionsUnited States