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Purpose

The purpose of this study is to establish the recommended phase 2 dose of eflornithine in combination with temozolomide in patients whose glioblastoma is newly diagnosed, and to evaluate safety and tolerability of this combination at that dose.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of World Health Organization (WHO) G4 classified GBM, IDH-wildtype per WHO 2021 tumor classification. - Completed external beam radiation therapy per standard of care. - Must have received at least 80% of planned daily doses of TMZ during chemoradiation. - Adequate hematologic, renal, hepatic, and other organ function as indicated by hematology and serum chemistry testing. - Willing to abstain from intercourse or use acceptable contraceptive methods. - If taking corticosteroids, must be on a stable or decreasing dose.

Exclusion Criteria

  • Recent history of recurrent or metastatic cancer that could confound response assessments - Prior systemic chemotherapy for GBM other than temozolomide during external beam radiation therapy. - Prior Optune treatment. - Active infection or serious intercurrent medical illness. - Poorly controlled seizures. - Significant cardiac disease within 6 months of enrollment. - Poorly controlled diabetes. - Use of another investigational agent within 30 days of enrollment.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Eflornithine Dose Level 1 + Temozolomide
  • Drug: Eflornithine (Dose Level 1)
    Eflornithine 2.3 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule
    Other names:
    • DFMO
  • Drug: Temozolomide
    Temozolomide 150 mg/m2 (with option to escalate per USPI maintenance phase instructions) administered orally once daily on a 5 days on, 23 days off schedule
    Other names:
    • Temodar
    • TMZ
Experimental
Eflornithine Dose Level 2 + Temozolomide
  • Drug: Eflornithine (Dose Level 2)
    Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule
    Other names:
    • DFMO
  • Drug: Temozolomide
    Temozolomide 150 mg/m2 (with option to escalate per USPI maintenance phase instructions) administered orally once daily on a 5 days on, 23 days off schedule
    Other names:
    • Temodar
    • TMZ
Experimental
Eflornithine Dose Level -1 + Temozolomide
  • Drug: Eflornithine (Dose Level -1)
    Eflornithine 1.75 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule
    Other names:
    • DFMO
  • Drug: Temozolomide
    Temozolomide 150 mg/m2 (with option to escalate per USPI maintenance phase instructions) administered orally once daily on a 5 days on, 23 days off schedule
    Other names:
    • Temodar
    • TMZ

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Thiru Pillay
205-934-1432
Tpillay@uabmc.edu

More Details

Status
Recruiting
Sponsor
Orbus Therapeutics, Inc.

Study Contact

Monika Varga
6506569424
monika.varga@orbustherapeutics.com

Detailed Description

This open label dose escalation and expansion study will be conducted using a standard dose-escalation design with escalating doses of eflornithine plus temozolomide at the approved dose level, followed by an expansion cohort that will further evaluate safety and preliminary efficacy of the combination at the recommended phase 2 dose. Duration of participation will be up to 56 weeks in total per patient: Screening Period - A maximum screening duration of 4 weeks. Treatment Period - Up to 48 weeks. Follow-Up Visit - 4 weeks from last treatment. A total of up to 66 patients will be enrolled in a non-randomized fashion (patients may be added to any of the dose levels below the RP2D to a maximum of approximately 20 per dose level with the intent of further characterizing safety and pharmacokinetics).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.