NovoTTF-200A Together With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed GBM

NCT03869242 | Unknown

• 1 other identifier: TLV-0492-18
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Study Objectives: To compare the efficacy and safety outcome of newly diagnosed GBM patients treated with NovoTTF-200A concomitant to RT and TMZ to those treated with RT and TMZ alone Study Design: Prospective, randomized, open label, standard of care control Study Hypothesis: The hypothesis of this study is that addition of NovoTTF-200A treatment to RT and TMZ will significantly increase progression free survival of newly diagnosed GBM patients compared to patients treated with RT and TMZ alone Sample Size: 60 patients with newly diagnosed GBM Study Population: Patients with tissue based diagnosis of GBM, above 18 years of age, of both genders after surgery or biopsy amenable for radiation therapy (RT) with concomitant TMZ (Stupp protocol1) Primary endpoint: Rate of progression-free survival at 12 months (PFS12) Secondary endpoints:

• Overall survival (OS)
• Progression-free survival (PFS)
• Progression free survival at 6 months (PFS6)
• 1 and 2-year survival rates
• Overall radiological response (ORR, per RANO criteria)
• Safety (adverse events severity and frequency)

Conditions

Glioblastoma

Keywords

Glioblastoma; NovoTTF-200A; Radiation Therapy; Temozolomide

Outcome Measures

Primary Outcomes (1)

• PFS12

  Rate of progression-free survival at 12 months

  12 months

Secondary Outcomes (5)

• PFS6

  6 months

• One and two year survival rate

  24 months

• Radiological response

  24 months

• adverse events

  36 months

• Radiological response

  26 months

Study Arms (2)

Experimental treatment arm

EXPERIMENTAL

RT with concomitant TMZ and NovoTTF-200A for 6 weeks followed by up to 24 months of maintenance TMZ in combination with NovoTTF-200A.

Device: NovoTTF-200A

control arm

ACTIVE COMPARATOR

RT with concomitant TMZ alone followed by maintenance TMZ chemotherapy in combination with NovoTTF-200A.

Device: NovoTTF-200A

Interventions

NovoTTF-200A DEVICE

newly diagnosed GBM patients treated with NovoTTF-200A concomitant to RT and TMZ.

Experimental treatment arm; control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of GBM according to WHO classification criteria.
• age ≥ 18 years
• Recovered from debulking surgery or biopsy-only.
• Planned treatment with RT/TMZ following maintenance TMZ (150-200 mg/m2 daily x 5 d, q28 days)
• Karnofsky performance status ≥ 70%
• Life expectancy ≥ least 3 months
• Participants of childbearing age must use effective contraception.
• All patients must sign written informed consent.
• Stable or decreasing dose of corticosteroids for the last 7 days prior to randomization, if applicable.

You may not qualify if:

• Early progressive disease before initiation of TMZ/RT.
• Participation in another clinical treatment trial
• Pregnancy
• Significant co-morbidities at baseline which would preclude maintenance RT or TMZ treatment, as determined by the investigator:
• Thrombocytopenia (platelet count \< 100 x 103/μL)
• Neutropenia (absolute neutrophil count \< 1.5 x 103/μL)
• CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)
• Significant liver function impairment - AST or ALT \> 3 times the upper limit of normal
• Total bilirubin \> 1.5 x upper limit of normal
• Significant renal impairment (serum creatinine \> 1.7 mg/dL, or \> 150 µmol/l)
• Implanted pacemaker, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
• Evidence of increased intracranial pressure (midline shift \> 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
• History of hypersensitivity reaction to TMZ or a history of hypersensitivity to DTIC.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv saurasky medical center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Glioblastoma

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 Study Contacts

Rachel Grossman, MD

CONTACT

+9723-6974397; rachelgr@tasmc.health.gov.il

Carmit Ben Harosh

CONTACT

+9723-6974397; carmitbh@tasmc.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A prospective, randomly controlled pivotal study will be conducted on 60 patients (randomized at a 1:1 ratio). Patients with histologically confirmed GBM will be randomized after debulking surgery or biopsy to either RT with concomitant TMZ and TTFields (200 kHz) for 6 weeks followed by up to 24 months of maintenance TMZ in combination with TTFields (experimental arm), or RT with concomitant TMZ alone followed by maintenance TMZ chemotherapy in combination with TTFields (control).

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 11, 2019
• Study Start: October 1, 2018
• Primary Completion: March 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 11, 2019

Record last verified: 2019-03

Locations

IL (1)