Study Of NOVOTTF-200A In Bevacizumab-Naive Subjects With Recurrent Grade III Malignant Astrocytoma

NCT03450850 | Completed Results DMC FDA Device

• 2 other identifiers: 20174031UCI 16-56
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 2 study in subjects with WHO Grade III Anaplastic Astrocytoma (G3 astrocytoma) who had progressive disease during first or second line treatment and who have not previously received any BEV or any experimental agents.

Conditions

Astrocytoma, Grade III

Outcome Measures

Primary Outcomes (1)

• Number of Participants Showing no Evidence of Disease Progression Six Months After Initiating Treatment With the Device.

  The primary objective is to estimate the proportion of participants showing no evidence of disease progression six months after initiating treatment with the device. Assessment is per RANO (2010) criteria.

  6 months

Secondary Outcomes (3)

• Number of Participants Who Experience Any Adverse Events Who Received NOVOTTF-200A.

  1 year

• Does the Treatment Significantly Modify the Patient's Quality of Life?

  Will be assessed at baseline and every two cycles (at the end of each even-numbered cycle of therapy) until treatment termination, an average of 24 months

• Correlations With Established Molecular Markers (ATRX, and/or Mutation and MGMT Promoter Methylation

  Assessed at screening.

Study Arms (1)

NOVOTTF-200A

OTHER

NOVOTTF-200A treatment in Bevacizumab-Naïve Subjects with Recurrent WHO Grade III Malignant Astrocytoma

Device: NOVOTTF-200A

Interventions

NOVOTTF-200A DEVICE

NOVOTTF-200A will be administered under appropriate guidelines. Monthly adherence rate \>= 75% (\>= 18 hours/day) over a 4-week cycle (28 days) will be strongly encouraged.

NOVOTTF-200A

Eligibility Criteria

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

You may qualify if:

• Understand and voluntarily sign and date an informed consent document before any study related assessments/procedures are conducted.
• Males and females of age ≥18 years at the time of the signing of the informed consent document.
• All subjects must have histologic evidence of G3 MG and radiographic evidence of recurrence or disease progression (defined as either a greater than 25% increase in the largest bi-dimensional product of enhancement, a new enhancing lesion or a significant increase in T2 FLAIR).
• Subjects with archival tumor tissue suitable for genetic testing must give permission to access and test the tissue; subjects without archival tumor tissue are eligible.
• No prior treatment with BEV or any anti-angiogenesis agents.
• At least 4 weeks from surgical resection and 12 weeks from end of radiotherapy prior to enrollment in this study, unless relapse is confirmed by tumor biopsy or new lesion outside of radiation field, or if there are two MRIs confirming progressive disease that are 8 weeks apart.
• All AEs resulting from prior chemotherapy, surgery or radiotherapy must have resolved to NCI-CTCAE (v. 4.03) Grade ≤1 (except for laboratory parameters outlined below).
• Laboratory results within 7 days prior to NOVOTTF-200A administration (transfusions and/or growth factor support may be used at the discretion of the Investigator during Screening):
• Hemoglobin ≥9 g/dL.
• Absolute neutrophil count (ANC) ≥1.5 × 109/L.
• Platelet count ≥100 × 109/L.
• Serum bilirubin ≤1.5 × upper limit of normal (ULN) or ≤3 × ULN if Gilbert's disease is documented.
• Aspartate transaminase (AST) ≤ 2.5 ULN.
• Serum creatinine ≤1.5 × ULN.
• Karnofsky Performance Status (KPS) score ≥70%.

You may not qualify if:

• The presence of any of the following will exclude a subject from enrollment:
• The presence of 1p19q LOH which is diagnostic for anaplastic oligodendroglioma (AO).
• Co-medication that may interfere with study results, e.g., immunosuppressive agents other than corticosteroids. (Steroid therapy for control of cerebral edema is allowed at the discretion of the investigator. Subjects should be on a stable dose of steroids for at least 1 week prior to study beginning.)
• Chemotherapy administered within 4 weeks (6 weeks for an IV nitrosoureas and 12 weeks for an implanted nitrosoureas wafer) prior to Day 1 of study treatment.
• Pregnancy or breastfeeding.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring IV antibiotics \& psychiatric illness/social situations that would limit adherence with study requirements, or disorders associated with significant immunocompromised state.
• Known previous/current malignancy requiring treatment within ≤ 3 years except for cervical carcinoma in situ, squamous or basal cell skin carcinoma and superficial bladder carcinoma.
• Any comorbid condition that confounds the ability to interpret data from the study as judged by the Investigator.

Sponsors & Collaborators

• Daniela A. Bota: lead
• NovoCure Ltd.: collaborator

Study Sites (1)

University of California, Irvine

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Astrocytoma

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Results Point of Contact

• Title: Chao Family Comprehensive Cancer Center, University of California, Irvine
• Organization: Chao Family Comprehensive Cancer Center, University of California, Irvine

ucstudy@uci.edu

1-877-UC-STUDY

Study Officials

• Daniela Bota, MD

  UC Irvine Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: March 1, 2018
• Study Start: May 21, 2020
• Primary Completion: September 7, 2023
• Study Completion: August 7, 2025
• Last Updated: February 17, 2026
• Results First Posted: July 16, 2025

Record last verified: 2025-08

Locations

US (1)