Study to Evaluate Ibudilast and TMZ Combo Treatment in Newly Diagnosed and Recurrent Glioblastoma

  • STATUS
    Recruiting
  • End date
    Dec 12, 2022
  • participants needed
    50
  • sponsor
    MediciNova
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Updated on 12 May 2022
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cancer
corticosteroids
measurable disease
karnofsky performance status
MRI
brain mri
recurrent disease
glioblastoma multiforme
temozolomide
gliosarcoma
gliadel
recurrent glioblastoma
gliadel wafer
beam radiation
malignant brain tumor

Summary

Part 1 is an open-label, single-arm, dose escalation study of MN-166 (ibudilast) and temozolomide (TMZ) combination treatment. Evaluate safety and tolerability of ibudilast (MN-166) and TMZ combination treatment for 1 cycle (28 days); determine dosage in dose-finding study. Part 2 will evaluate efficacy of fixed-dose MN-166 (ibudilast) and TMZ combination treatment for 6 cycles (~6 months) until disease progression, unacceptable tolerability and/or toxicity or loss of life.

Description

This is a single-center open-label, dose-escalation study to evaluate the safety, tolerability and efficacy of MN-166 (ibudilast) and Temozolomide combination treatment in patients with newly diagnosed or recurrent glioblastoma. To be eligible, subjects are histologically confirmed glioblastoma or gliosarcoma, or astrocytomas with molecular features of glioblastoma, WHO Grade 4. Recurrent glioblastoma patients must have a Karnofsky Performance Status (KPS) ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Patients having newly diagnosed glioblastoma, gliosarcoma, or astrocytomas with molecular features of glioblastoma must have a KPS ≥60 and ECOG score 0-1. This is divided into a dose-escalation phase (Part 1) followed by a fixed-dose phase (Part 2).

Part 1 will evaluate the safety and tolerability of MN-166 when given in combination with temozolomide, and determine the dose of MN-166 to be used in Part 2 of the study. Up to 18 adult subjects are planned to be enrolled in Part 1.

Part 2 will evaluate the efficacy of MN-166 and temozolomide combination treatment as measured by the proportion of subjects who are progression-free at 6 months. Other outcome measures include the evaluation of overall survival, response rate, and median six-month progression-free survival up to 2 years and up to 50 subjects are planned to be enrolled in Part 2.

Details
Condition Glioblastoma, Recurrent Glioblastoma, GBM, Newly Diagnosed Glioblastoma
Treatment Temozolomide, MN-166
Clinical Study IdentifierNCT03782415
SponsorMediciNova
Last Modified on12 May 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age 18 or older
Histologically confirmed GBM (glioblastoma), WHO Grade 4
Patients must have a Karnofsky Performance Status (KPS) ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (see Appendix 7)
Previously received standard front-line GBM treatment including maximal surgical resection followed by external beam radiation therapy and TMZ therapy. Prior use of NovoTTF (Optune) and Gliadel wafers is allowed
Patients must be in first relapse
Relapse is defined as progression following initial therapy (i.e., radiation and/or chemotherapy). The intent therefore is that patients had no more than 1 prior therapy (i.e., initial treatment). If the patient had a surgical resection for relapsed disease and no anti-cancer therapy was instituted for up to 12 weeks, and the patient undergoes another surgical resection, this is considered to constitute one (1) relapse
Documented recurrence or progression by brain MRI imaging ≤14 days before study registration
Measurable disease by RANO criteria (≥ 10 mm x 10 mm)
Major Inclusion criteria for newly diagnosed patients
Ages 18 or older
Newly diagnosed glioblastoma or gliosarcoma (WHO Grade 4) confirmed by histology or astrocytomas with molecular features of gliobastoma
Starting maintenance therapy with temozolomide (150 mg/m^2 on Days 1-5 every 28 days) within 4 weeks prior to screening phase
If patient is receiving corticosteroid, dose must be stable or decreasing for at least 5 days prior to the scan. If steroids are added or the steroid dose is increased between the date of the pretreatment MRI and the start of study, a new baseline MRI or CT scan is required
Karnofsky Performance Status ≥60 at time of screening
ECOG score of 0 or 1 at time of screening
Life expectancy of at least 3 months

Exclusion Criteria

History of Grade 2 (CTCAE v4.0) or greater intracranial or intratumoral hemorrhage confirmed by either MRI or CT scan
Current use of anticoagulant treatment with coumadin (low-molecular-weight heparin and factor Xa inhibitors are permitted)
Any systemic illness or unstable medical condition that might pose additional risk, including: cardiac, unstable metabolic or endocrine disturbances, renal or liver disease
Patients with a history of a different malignancy except the following circumstances
They have been disease-free for at least 2 years prior to starting study drug and are deemed by the investigator to be at low risk for recurrence of that malignancy. Patients with the following cancers are eligible if diagnosed and treated within the past 2 years: i. Cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
Patients who have not recovered to ≤ Grade 1 toxicity by NCI CTCAE v4.0 from the toxic effects of previous therapy with exception of lymphopenia, alopecia and fatigue; 9) For use of other investigational drug or other anti-tumor treatment, the following time periods must have elapsed from the projected start of scheduled study treatment
4 weeks or 5 half-lives (whichever is shorter) from any investigational agent
4 weeks from cytotoxic therapy (except 23 days for TMZ; 6 weeks from nitrosoureas)
6 weeks from antibodies treatment (i.e., anti-VEGF antibody)
4 weeks or 5 half-lives (whichever is shorter) from other anti-tumor therapies
2 days from NOVO-TTF (Optune®)
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