Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06177964
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2023-12-11
Brief Title:
Lerapolturev PVSRIPO in GBM
Sponsor:
Darell Bigner
Organization:
Duke University
Study Overview
Official Title:
Randomized Phase 2 Clinical Trial of Repeated Intratumoral and Cervical Perilymphatic Lerapolturev Injections Versus Lomustine in Recurrent Glioblastoma GBM
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
The study will be conducted in two stages Approximately twelve patients with recurrent supratentorial glioblastoma will enroll in stage 1
Stage 1 is a safety lead-in which will assess the safety of lerapolturev when infused twice 4 days apart via Convection Enhanced Delivery CED in the residual disease of recurrent Glioblastoma GBM patients following maximal safe resection of the enhancingnecrotic portion of the disease recurrence
A tissue biopsy of the area infused will be recommended 5 weeks 1 week after the 2nd lerapolturev infusion via CED if imaging changes suggest tumor progression vs immune effect on the MRI obtained 4-5 weeks after the 2nd lerapolturev infusion via CED
Stage 2 is a Phase 2 randomized clinical trial to compare the efficacy and safety of two treatment regimens for recurrent GBM patients who undergo maximal safe resection for their recurrence Approximately eighty patients with recurrent supratentorial glioblastoma will enroll in stage 2 of the study
Stage 2 has 2 arms and is randomized like the flip of a coin Arm 1 is Lerapolturev and Arm 2 is Lomustine After the recurrent tumor has been removed by surgery subjects will be randomly assigned to receive either the FDA-approved chemotherapy lomustine or the study drug lerapolturev Subjects receive lerapolturev infused in the residual disease via CED twice 4-day apart About 1 week after the 2nd lerapolturev infusion subjects will start subcutaneous under the skin injections of lerapolturev into the area of the cervical lymph nodes head and neck nearest to their tumor weekly for 4 weeks and afterward every 3 weeks for about a year
Subjects assigned to receive lomustine will begin taking it 3-4 weeks after surgery to remove their recurrent tumor One prescribed dose of lomustine will be taken no more than once every 6 weeks for no more than 1 year or up to 9 cycles
Subjects will be followed for serious adverse events side effects for 30 days after stopping the study Subjects medical records will be reviewed for the remainder of their life in order to collect data on subsequent treatments disease progression tumor sizevolume and survival
There are risks to the study drug lerapolturev and the chemotherapy drug lomustine The most common risks of lerapolturev are headache seizure weakness on one side of the body difficulty thinking or processing difficulty receiving or responding to sensory information fatigue and difficulty speaking or comprehending Risks associated with infusion procedure include mild discomfort at the infusion site bleeding in the brain pain infection and swelling of the brain The study drug and procedures used together could also potentially cause more serious side effects The most common risks of lomustine are changes in your red blood cell count changes in platelets changes in your liver feeling confused and tired poor appetite and loss of ability to conceive or father a child
Stage 1 is a safety lead-in which will assess the safety of lerapolturev when infused twice 4 days apart via Convection Enhanced Delivery CED in the residual disease of recurrent Glioblastoma GBM patients following maximal safe resection of the enhancingnecrotic portion of the disease recurrence
A tissue biopsy of the area infused will be recommended 5 weeks 1 week after the 2nd lerapolturev infusion via CED if imaging changes suggest tumor progression vs immune effect on the MRI obtained 4-5 weeks after the 2nd lerapolturev infusion via CED
Stage 2 is a Phase 2 randomized clinical trial to compare the efficacy and safety of two treatment regimens for recurrent GBM patients who undergo maximal safe resection for their recurrence Approximately eighty patients with recurrent supratentorial glioblastoma will enroll in stage 2 of the study
Stage 2 has 2 arms and is randomized like the flip of a coin Arm 1 is Lerapolturev and Arm 2 is Lomustine After the recurrent tumor has been removed by surgery subjects will be randomly assigned to receive either the FDA-approved chemotherapy lomustine or the study drug lerapolturev Subjects receive lerapolturev infused in the residual disease via CED twice 4-day apart About 1 week after the 2nd lerapolturev infusion subjects will start subcutaneous under the skin injections of lerapolturev into the area of the cervical lymph nodes head and neck nearest to their tumor weekly for 4 weeks and afterward every 3 weeks for about a year
Subjects assigned to receive lomustine will begin taking it 3-4 weeks after surgery to remove their recurrent tumor One prescribed dose of lomustine will be taken no more than once every 6 weeks for no more than 1 year or up to 9 cycles
Subjects will be followed for serious adverse events side effects for 30 days after stopping the study Subjects medical records will be reviewed for the remainder of their life in order to collect data on subsequent treatments disease progression tumor sizevolume and survival
There are risks to the study drug lerapolturev and the chemotherapy drug lomustine The most common risks of lerapolturev are headache seizure weakness on one side of the body difficulty thinking or processing difficulty receiving or responding to sensory information fatigue and difficulty speaking or comprehending Risks associated with infusion procedure include mild discomfort at the infusion site bleeding in the brain pain infection and swelling of the brain The study drug and procedures used together could also potentially cause more serious side effects The most common risks of lomustine are changes in your red blood cell count changes in platelets changes in your liver feeling confused and tired poor appetite and loss of ability to conceive or father a child
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None