Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06169280
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2023-12-05
Brief Title:
Repeated Neural Stem Cell Based Virotherapy for Newly Diagnosed High Grade Glioma
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Phase I Study of Repeated Neural Stem Cell Based Virotherapy in Combination With N-Acetylcysteine Amid NACA and Standard Radiation and Chemotherapy for Newly Diagnosed High Grade Glioma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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 goal of this clinical trial is to learn about the safety and feasibility of administering repeated doses of neural stem cell NSC-conditionally replicative adenovirus CRAd-survivin S-protomer pk7 in persons with newly diagnosed high grade glioma
The main questions it aims to answer are
whether multiple doses of NSC-CRAd-S-pk7 are safe and feasible
how multiple doses of NSC-CRAd-S-pk7 influence tumor response overall survival time to tumor progression and quality of life
Participants will
undergo a biopsy to confirm high grade glioma then receive the first dose of NSC-CRAd-S-pk7 into the brain
about 2 weeks later undergo surgery to remove the tumor and receive the second dose of NSC-CRAd-S-pk7 into the brain
start chemoradiation about 2 weeks after surgery then about 2 weeks later receive the 3rd dose of NSC-CRAd-S-pk7 into the brain
four weeks later at the end of chemoradiation receive a fourth dose of NSC-CRAd-S-pk7 into the brain
after radiation is finished receive standard of care chemotherapy and tumor-treating fields Two additional doses of NSC-CRAd-S-pk7 will be given every 4 weeks
Every other patient enrolled will receive N-acetylcysteine amide NACA from registration until the day prior to surgery and the second dose of NSC-CRAd-S-pk7
The main questions it aims to answer are
whether multiple doses of NSC-CRAd-S-pk7 are safe and feasible
how multiple doses of NSC-CRAd-S-pk7 influence tumor response overall survival time to tumor progression and quality of life
Participants will
undergo a biopsy to confirm high grade glioma then receive the first dose of NSC-CRAd-S-pk7 into the brain
about 2 weeks later undergo surgery to remove the tumor and receive the second dose of NSC-CRAd-S-pk7 into the brain
start chemoradiation about 2 weeks after surgery then about 2 weeks later receive the 3rd dose of NSC-CRAd-S-pk7 into the brain
four weeks later at the end of chemoradiation receive a fourth dose of NSC-CRAd-S-pk7 into the brain
after radiation is finished receive standard of care chemotherapy and tumor-treating fields Two additional doses of NSC-CRAd-S-pk7 will be given every 4 weeks
Every other patient enrolled will receive N-acetylcysteine amide NACA from registration until the day prior to surgery and the second dose of NSC-CRAd-S-pk7
Detailed Description:
The treatment regimen contains 3 phases
Surgical phase
Patients undergo a biopsy and upon intraoperative confirmation of high grade glioma NSC-CRAd-S-pk7 dose 1 will be injected into the biopsy site Patients will undergo resection of the tumor 14 - 3 days later administration of second dose of the investigational product NSC-CRAd-S-pk7 dose 2 and implantation of the catheter system The investigational product will then be given monthly for a total of 6 doses see below
Every other patient enrolled beginning with the first patient will also undergo oral administration of NACA an over-the-counter drug that acts as a free radical scavenger and improves NSC viability starting at registration until the day prior to surgical tumor resection and planned investigational product injection 2
Radiotherapy phase
After recovery from surgery usually within 2 weeks standard chemoradiotherapy will be initiated consisting of daily radiotherapy 2 Gy per fraction x 30 fractions and concomitant temozolomide TMZ chemotherapy 75 mgm2 daily from day 1 of RT until last day of RT
About 10-14 days into radiotherapy approx 4 weeks after intraoperative dose 2 patients will be receiving NSC-CRAd-S-pk7 dose 3 through the previously implanted catheter system This also marks the beginning of the formal dose-limiting toxicity DLT period as this virus survivin gene promoter is activated by the concomitant irradiation
Four weeks later ie at the end of radiotherapy dose 4 is administered as previously provided no DLT toxicity has been observed and viral treatment related toxicities have returned to grade 2
Adjuvant also called maintenance phase
As per standard of care approx 4 weeks after end of radiotherapy patients will start maintenance TMZ chemotherapy 150 - 200 mgm2 daily x 5 every 28 days and loco-regional treatment with alternating Tumor Treating Fields TTFields Optune NSC-CRAd-S-pk7 doses 5 and 6 will be administered concurrently 3 days with adjuvant cycle 1 and 2 of TMZ
Surgical phase
Patients undergo a biopsy and upon intraoperative confirmation of high grade glioma NSC-CRAd-S-pk7 dose 1 will be injected into the biopsy site Patients will undergo resection of the tumor 14 - 3 days later administration of second dose of the investigational product NSC-CRAd-S-pk7 dose 2 and implantation of the catheter system The investigational product will then be given monthly for a total of 6 doses see below
Every other patient enrolled beginning with the first patient will also undergo oral administration of NACA an over-the-counter drug that acts as a free radical scavenger and improves NSC viability starting at registration until the day prior to surgical tumor resection and planned investigational product injection 2
Radiotherapy phase
After recovery from surgery usually within 2 weeks standard chemoradiotherapy will be initiated consisting of daily radiotherapy 2 Gy per fraction x 30 fractions and concomitant temozolomide TMZ chemotherapy 75 mgm2 daily from day 1 of RT until last day of RT
About 10-14 days into radiotherapy approx 4 weeks after intraoperative dose 2 patients will be receiving NSC-CRAd-S-pk7 dose 3 through the previously implanted catheter system This also marks the beginning of the formal dose-limiting toxicity DLT period as this virus survivin gene promoter is activated by the concomitant irradiation
Four weeks later ie at the end of radiotherapy dose 4 is administered as previously provided no DLT toxicity has been observed and viral treatment related toxicities have returned to grade 2
Adjuvant also called maintenance phase
As per standard of care approx 4 weeks after end of radiotherapy patients will start maintenance TMZ chemotherapy 150 - 200 mgm2 daily x 5 every 28 days and loco-regional treatment with alternating Tumor Treating Fields TTFields Optune NSC-CRAd-S-pk7 doses 5 and 6 will be administered concurrently 3 days with adjuvant cycle 1 and 2 of TMZ
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