Lerapolturev (PVSRIPO) in GBM

Conditions

• Recurrent Supratentorial Glioblastoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lerapolturev — DRUG
  Lerapolturev (intratumoral) will be dosed at 2x108 TCID50 in 3.0 mL x 2 doses (total dose 4x108 TCID50) by Convection Enhanced Delivery. For the patients randomized to the lerapolturev Arm 1 of Stage 2, seven days (±2 days) following completion of the 2nd intratumoral infusion of lerapolturev, patients will begin cervical perilymphatic subcutaneous injection of lerapolturev at a dose of 2 x 108 TCID50 (in 0.5 ml diluent) around the cervical lymph node chain ipsilateral to the intracranial tumor.
• Lomustine Pill — DRUG
  Lomustine will be given as a single oral dose of 110 mg/m2 every six weeks for up to 9 cycles.

Study Details

The purpose of this research study is to determine the safety and efficacy of administering two doses of lerapolturev in residual disease (within tumor margins) after surgery, followed later by repeated injections of lerapolturev in the subcutaneous area (under the skin) around the lymph nodes of the head and neck for adult patients diagnosed with recurrent glioblastoma at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke.

Key Dates

Start date

Jul 15, 2024

Status verified

Jul 2025

Primary completion

Feb 28, 2029

Completion

Feb 28, 2029

Study Design

Enrollment

92 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Lerapolturev Arm (Stage 1)
  Lerapolturev (intratumoral) will be dosed by Convection Enhanced Delivery (CED), infused twice, 4 days apart, in the remaining disease of recurrent Glioblastoma (rGBM) subjects following maximal safe resection of the disease recurrence. To assess treatment response and/or immunologic responses in the brain, a tissue biopsy of the area infused will be recommended 5 weeks (± 1 week) after the 2nd lerapolturev infusion via CED, in the event that changes suggestive of tumor progression are seen on the MRI obtained 4-5 weeks after the 2nd lerapolturev infusion via CED. .
• Experimental: Lerapolturev Arm (Stage 2 - Arm 1)
  Lerapolturev (intratumoral) will be given by Convection Enhanced Delivery (CED), infused twice, 4 days apart, in the remaining disease of recurrent Glioblastoma (rGBM) subjects following maximal safe resection of their disease recurrence. This will be followed by subcutaneous injections of lerapolturev in the cervical perilymphatic (CPL) area on the same side as their tumor, weekly for 4 weeks and afterward every 3 weeks for about a year.
• Active Comparator: Lomustone (Stage 2 Arm 2)
  Following maximal safe resection of their tumor recurrence subjects will receive Lomustine as a single oral dose of 110 mg/m2 every six weeks for up to 9 cycles.

Primary Outcome Measure

Proportion of patients at each dose level who experienced a dose-limiting toxicity - Stage 1 [ Time Frame: Up to 1 year ]

Central Contacts

• Madison Shoaf, MD
  919-684-5301
  [email protected]
• Stevie Threatt
  919-684-5301
  [email protected]

Locations (1)

Find similar trials in Durham, NC

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