Study of NovoTTF-200A Alone and With Temozolomide in Patients With Low-Grade Gliomas

NCT02507232 | Terminated Early Phase 1 FDA Device

• 1 other identifier: JWCI-16-1101
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to test the effectiveness and safety of the NovoTTF-200A device in patients with low-grade glioma when it's used by itself or used together with temozolomide. Researchers would also like to know whether the use of NovoTTF-200A, with or without temozolomide, is associated with fewer negative side effects on mental function that may be seen with other currently used treatment options.

Conditions

Glioma

Keywords

glioma; temozolomide; brain; NovoTTF-200A; cancer; low-grade glioma

Outcome Measures

Primary Outcomes (1)

• Toxicity associated with treatment with NovoTTF-200A alone and combined with temozolomide

  Participants will be assessed for the development of toxicity according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.03. Dose adjustments will be made according to the system showing the greatest degree of toxicity.

  24 months

Secondary Outcomes (5)

• Efficacy of NovoTTF-200A alone and combined with temozolomide

  24 months

• 12-month objective response rate (ORR) of NovoTTF-200A alone and combined with temozolomide

  12 months

• Effects of NovoTTF-200A alone and combined with temozolomide on seizure activity

  24 months

• Effects of NovoTTF-200A alone and combined with temozolomide on quality of life (QOL)

  24 months

• Frequency of transformation from low-grade glioma into high-grade glioma

  24 months

Study Arms (2)

Arm A

ACTIVE COMPARATOR

NovoTTF-200A

Device: NovoTTF-200A

Arm B

ACTIVE COMPARATOR

NovoTTF-200A + Temozolomide 50 mg/m2 daily (oral)

Device: NovoTTF-200A; Drug: Temozolomide

Interventions

NovoTTF-200A DEVICE

12 cycles

Arm A; Arm B

Temozolomide DRUG

50 mg/m2/day rounded to the nearest 5 mg. One cycle is 28 days and will be given for 12 cycles

Also known as: Temodar

Arm B

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed low-grade glioma including astrocytoma grade 2, oligodendroglioma grade 2, or oligoastrocytoma grade 2.
• Tumor is supratentorially located and measureable.
• Disease that has not received prior radiation, radiosurgery, chemotherapy, or other investigational treatment directed at the brain tumor at any time. Previous surgical procedures is allowed.
• Age ≥ 18 years.
• Life expectancy \> 12 weeks.
• Either not receiving steroids for disease symptoms or are on stable dose of steroids for at least 5 days.
• Karnofsky Performance Status (KPS) ≥ 60%
• Adequate hematologic function evidenced by:
• Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
• Platelet count ≥ 100 x 109/L
• Hemoglobin ≥ 9.0 g/dL
• Adequate renal function evidenced by:
• AST/SGOT and ALT/SPGT ≤ 2.5 X institutional upper limit of normal
• Total bilirubin ≤ 1.5 x institution's ULN
• Serum creatinine ≤ 1.5 x institution's ULN

You may not qualify if:

• Pilocytic astrocytoma, ganglioglioma, pleomorphic xanthoastrocytoma, or dysembryoplastic neuroepithelial tumors are not eligible.
• Current or anticipated use of other investigational agents.
• Implanted electronic medical device in the brain (e.g., deep brain stimulator, vagus nerve stimulator, programmable shunt).
• Patients who are less than 4 weeks from surgery or have insufficient recovery from surgical-related trauma or wound healing.
• Severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study treatment (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric illness/social situations that would limit compliance with study requirements).
• Severe cardiac insufficiency (NYHA III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease.
• Pregnant or nursing.

Sponsors & Collaborators

• Santosh Kesari: lead
• NovoCure Ltd.: collaborator

Study Sites (2)

John Wayne Cancer Institute

Santa Monica, California, 90404, United States

Location

Providence Brain & Spine Institute

Portland, Oregon, 97225, United States

Location

MeSH Terms

Conditions

Glioma; Neoplasms

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Santosh Kesari, MD, PhD

  Saint John's Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: July 23, 2015
• Study Start: April 17, 2017
• Primary Completion: July 27, 2020
• Study Completion: July 27, 2020
• Last Updated: July 28, 2020

Record last verified: 2020-07

Locations

US (2)