CompletedPhase 2

Lerapolturev in Recurrent Malignant Glioma

United States121 participantsStarted 2017-06-01

Plain-language summary

This is a phase 2 study of lerapolturev, an oncolytic polio/rhinovirus recombinant, in adult patients with recurrent World Health Organization (WHO) grade IV malignant glioma.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients must have a recurrent (first or second recurrence only, including this recurrence; transformation from a lower grade tumor to a WHO grade IV malignant glioma will be considered a first recurrence) supratentorial WHO grade IV malignant glioma based on imaging studies with measurable disease (a minimum measurement of 1 cm and maximum of 5.5 cm of contrast-enhancing tumor) with prior histopathology consistent with a WHO grade IV malignant glioma confirmed by the site's neuropathologist or the neuropathologist's designate.
✓. Male patients who are sexually active are eligible if he and/or his partner(s) meets the criteria outlined in the protocol. Female subjects are eligible if he and/or his partner(s) meets the criteria outlined in the protocol.
✓. Age ≥ 18 years of age.
✓. Karnofsky Performance Status (KPS) Score ≥ 70%.
✓. Prothrombin and Partial Thromboplastin Times ≤ 1.2 x normal prior to biopsy.
✓. Total bilirubin, serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), alkaline phosphatase ≤ 2.5 x normal prior to biopsy.
✓. Neutrophil count ≥ 1000 prior to biopsy.
✓. Hemoglobin ≥ 9 prior to biopsy.

Exclusion criteria

✕. Females who are pregnant or breast-feeding.
✕. Patients with an impending, life-threatening cerebral herniation syndrome, based on the assessment of the study neurosurgeons, their designate, and the reviewer designated by the sponsor.
✕. Patients with severe, active co-morbidity, defined as in the protocol.
✕. Patients with a previous history of neurological complications due to PV infection.
✕. Patients who have not recovered from the toxic effects of prior chemo- and/or radiation therapy. Guidelines for this recovery period are dependent upon the specific therapeutic agent being used.
✕. Patients may not have received tumor treating fields (≤ 1 week), chemotherapy or bevacizumab ≤ 4 weeks \[except for nitrosourea and lomustine (≤ 6 weeks); metronomic dosed chemotherapy, such as daily temozolomide, etoposide or cyclophosphamide (≤ 1 week)\] prior to starting the study drug.
✕. Patients may not have received immunotherapy ≤ 4 weeks prior to starting the study drug unless patients have recovered from side effects of such therapy.
✕. Patients may not be less than 12 weeks from radiation therapy of the brain, unless progressive disease outside of the radiation field or 2 progressive scans at least 4 weeks apart or histopathologic confirmation.

What they're measuring

Number of Participants With Objective Radiographic Response

Timeframe: up to 5 years

Duration of Objective Radiographic Response

Timeframe: up to 5 years

Trial details

NCT IDNCT02986178

SponsorIstari Oncology, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-30

Results submitted2025-02-19

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