NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma

NCT01894061 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CASE3313
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

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-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.

Conditions

Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Recurrent Adult Brain Tumor

Keywords

adult giant cell glioblastoma; adult glioblastoma; adult gliosarcoma; recurrent adult brain tumor; Bevacizumab-naive; NovoTTF-100A

Outcome Measures

Primary Outcomes (1)

• Percent of Participants With 6-month Progression-free Survival (PFS6)

  Efficacy of therapy as measured by percent of participants with (PFS6). This trial will be considered successful if at least 20% of participants achieve PFS at 6 months. Disease progression is defined by RANO criteria. In cases where the RANO criteria cannot be applied, progression should be based on unequivocal evidence of progressive disease sufficient to require a change in therapy. The Modified RANO criteria are a set of guidelines for evaluating treatment response clinical trials. Modified RANO Response Criteria include levels of response including Complete Response (CR), Partial Response (PR), Minor Response (MR), Stable Disease (SD), or Progressive Disease.

  6 months

Secondary Outcomes (7)

• Objective Response Rate (ORR) Based on RANO Criteria

  30 days after treatment completion through study completion, an average of 5 years, 9 months

• Number of Participants Experiencing Grade 3/4 Toxicities Related to Therapy Combination Per by CTCAE Version 4.0.

  5 years, 9 months

• Median Overall Survival

  30 days after treatment completion (Treatment continued until disease progression in the brain, death, or unacceptable side effects to patient)

• Median Time-to-progression

  30 days after treatment completion (Treatment continued until disease progression in the brain, death, or unacceptable side effects to patient)

• Time to Reliable Change in Neurocognitive Function (NCF)

  30 days after treatment completion (Treatment continued until disease progression in the brain, death, or unacceptable side effects to patient)

Study Arms (1)

Bevacizumab and NovoTTF-100A

EXPERIMENTAL

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.

Biological: Bevacizumab; Device: NovoTTF-l00A; Other: Quality of Life Assessment

Interventions

Bevacizumab BIOLOGICAL

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.

Also known as: Avastin, anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, anti-VEGF rhuMAb, recombinant humanized anti-VEGF monoclonal antibody, rhuMAb VEGF

Bevacizumab and NovoTTF-100A

NovoTTF-l00A DEVICE

NovoTTF-100A will be worn continuously.

Also known as: electric field therapy

Bevacizumab and NovoTTF-100A

Quality of Life Assessment OTHER

Functional Assessment of Cancer Therapy including Brain Tumor module (FACT-Br) questionnaire

Also known as: FACT-Br questionnaire

Bevacizumab and NovoTTF-100A

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• weeks since last non-cytotoxic therapy
• weeks must have elapsed since the completion of a non-nitrosourea-containing chemotherapy regimen

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• NovoCure Ltd.: collaborator

Study Sites (3)

University of Cincinnati

Cincinnati, Ohio, 45220, United States

Location

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Glioblastoma; Gliosarcoma; Brain Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. David Peereboom
• Organization: Cleveland Clinic, Case Comprehensive Cancer Center

TaussigResearch@ccf.org

1-866-223-8100

Study Officials

• David Peereboom, MD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 9, 2013
• Study Start: September 18, 2013
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: February 17, 2025
• Results First Posted: February 17, 2025

Record last verified: 2025-02

Locations

US (3)