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NovoTTF-100A With Bevacizumab and Carmustine in Treating Patients With Glioblastoma Multiforme in First Relapse

Study Purpose

This phase II trial studies the safety of NovoTTF-100A in combination with bevacizumab and carmustine and to see how well they work in treating patients with glioblastoma multiforme that has returned for the first time. NovoTTF-100A, a type of electric field therapy, delivers low intensity, alternating "wave-like" electric fields that may interfere with multiplication of the glioblastoma multiforme cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carmustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving NovoTTF-100A together with bevacizumab and carmustine may be an effective treatment for glioblastoma multiforme.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 22 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Histologically confirmed GBM.
  • - Progressive disease after temozolomide and radiation therapy (in "first relapse") - At least 28 days since chemotherapy or radiation.
  • - Karnofsky performance score at least 70% - Platelet count >= 130/mm^3.
  • - Absolute neutrophil count >= 1500/mm^3.
  • - Calculated creatinine clearance greater than 45 mg/dl using the Cockcroft-Gault formula.
  • - Aspartate aminotransferase (AST) < 2 times the upper limit of normal.
  • - Bilirubin < 1.5 times the upper limit of normal.
  • - Subjects with child-bearing potential agree to use effective means of contraception.

Exclusion Criteria:

  • - Prior systemically administered nitrosoureas or vascular endothelial growth factor (VEGF) targeted therapy.
  • - Chemotherapy for glioma other than temozolomide or Gliadel wafers (steroids are allowed) - Pregnant or breast feeding.
  • - Active inflammatory bowel disease.
  • - Abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months.
  • - Hypertension: systolic blood pressure (SBP) > 150 or diastolic blood pressure (DBP) > 100 mm mercury (Hg) despite antihypertensive medications.
  • - New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF); myocardial infarction or unstable angina within 6 months.
  • - History of thrombosis.
  • - Symptomatic peripheral vascular disease, stroke or transient ischemic attack within 6 months.
  • - Bleeding risks: Required to be on therapeutic anticoagulation (aspirin is allowed), coagulopathy (e.g. hemophilia or von Willebrand's disease); any grade III or greater hemorrhage, major surgical procedure, or significant trauma within 28 days; core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days.
  • - Activated partial thromboplastin time (APTT) must not exceed 32.5 seconds (normal range 21.8-31.5 seconds); international normalized ratio (INR) must not exceed 1.30 (normal range 0.87-1.18) - Serious, non-healing wound, ulcer, or bone fracture.
  • - Active implanted medical device (e.g. deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, and programmable shunts), a skull defect (such as missing bone with no replacement), a shunt, or bullet fragments.
  • - Known sensitivity to conductive hydrogels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes.
  • - Human immunodeficiency virus (HIV) positive.
  • - Proteinuria at screening as demonstrated by urine dipstick >= 2+ - Prior organ transplantation.
  • - Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies.
  • - Aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), clopidogrel or any other drug whose goal is to inhibit platelet function.
- Unable to give signed informed consent

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02348255
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of California, Davis
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Robert O'Donnell
Principal Investigator Affiliation University of California, Davis
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH, Industry
Overall Status Withdrawn
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Adult Brain Glioblastoma, Recurrent Adult Brain Neoplasm
Additional Details

PRIMARY OBJECTIVES:

  • I. Establish the safety of NovoTTF-100A in combination with bevacizumab and BCNU (carmustine) in glioblastoma multiforme (GBM) patients who have relapsed after chemoradiation therapy (first relapse).
  • II. Determine the 6 month overall survival (OS).
  • III. Determine the 6 month progression free survival (PFS).
  • IV. Evaluate the effect of this therapy regimen on quality-of-life.
OUTLINE: Patients receive bevacizumab intravenously (IV) over 30-90 minutes every 2 weeks beginning on day -7 for up to 13 doses and carmustine IV over 4 hours every 8 weeks beginning on day 1 for up to 3 doses. Patients also undergo NovoTTF-100A according to standard procedures starting one week before the first dose of carmustine. After completion of study treatment, patients are followed up for 12 months.

Arms & Interventions

Arms

Experimental: Treatment (bevacizumab, carmustine, NovoTTF-100A)

Patients receive bevacizumab IV over 30-90 minutes every 2 weeks beginning on day -7 for up to 13 doses and carmustine IV over 4 hours every 8 weeks beginning on day 1 for up to 3 doses. Patients also undergo NovoTTF-100A according to standard procedures starting one week before the first dose of carmustine.

Interventions

Procedure: - Electric Field Therapy

Undergo NovoTTF-100A

Biological: - Bevacizumab

Given IV

Drug: - Carmustine

Given IV

Other: - Quality-of-Life Assessment

Ancillary studies

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Sacramento, California

Status

Address

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817

Piedmont Hospital, Atlanta, Georgia

Status

Address

Piedmont Hospital

Atlanta, Georgia, 30309

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