Ignite Creation Date:
2024-05-06 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05283109
Status:
RECRUITING
Last Update Posted:
2023-09-08
First Post:
2022-03-08
Brief Title:
ETAPA I Peptide-based Tumor Associated Antigen Vaccine in GBM
Sponsor:
Mustafa Khasraw MBChB MD FRCP FRACP
Organization:
Duke University
Study Overview
Official Title:
ETAPA I Evaluation of Tumor Associated P30-Peptide Antigen I A Pilot Trial of Peptide-based Tumor Associated Antigen Vaccines in Newly Diagnosed Unmethylated and Untreated Glioblastoma GBM
Status:
RECRUITING
Status Verified Date:
2024-08
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:
ETAPA I
Brief Summary:
This is a phase 1b study of P30-linked EphA2 CMV pp65 and survivin vaccination collectively called the P30-EPS vaccine in HLA-A0201 positive patients with a newly diagnosed unmethylated and untreated World Health Organization WHO grade IV malignant glioma
Detailed Description:
This is a phase 1b study of P30-linked EphA2 CMV pp65 and survivin vaccination collectively called the P30-EPS vaccine in HLA-A0201 positive patients with a newly diagnosed unmethylated and untreated World Health Organization WHO grade IV malignant glioma at the Preston Robert Tisch Brain Tumor Center PRTBTC at Duke is planned to address the following primary objective Evaluate the safety profile of a cancer vaccine comprised of P30-linked EphA2 CMV pp65 and survivin peptides
A maximum of 36 patients with a newly diagnosed previously untreated WHO grade IV malignant glioma that is MGMT promoter unmethylated will be treated in this study after undergoing standard of care surgical resection followed by 6 weeks of radiation therapy XRT with concomitant temozolomide TMZ and providing informed consent Patients will receive seven P30 linked-EphA2 -CMV pp65 and -survivin P30-EPS peptide vaccines over two phases The first 5 will be given during the Priming Phase day 1 through day 22 The final 2 will be given during the Booster Phase day 84 2 days and day 140 2 days During the Booster Phase on Day 84 patients will also be given 20ugkg Hiltonol injections to administer at home every 2 weeks until they return on Day 140 Blood will be drawn throughout the study to investigate the immune response to P30-EPS vaccination The study will enroll two patient strata patients who are CMV seronegative and patients who are CMV seropositive Within each stratum cohorts of 3 patients will initially be accrued to the study to assess the toxicity associated with the vaccine The starting dose of P30-EPS is 300 μgpeptidedose and the dose will be escalated to 400 μgpeptidedose In the event of unacceptable dose-limiting toxicity the dose will be de-escalated to 200 μgpeptidedose dose level minus one Acute toxicity monitoring will focus on dose-limiting toxicities as defined in Section 912 of the protocol occurring between vaccine 1 and 30 days after vaccine 5 The most common side effects of peptide vaccines are redness or swelling at the injection site local changes to the texture of your skin hardening at the injection site itching allergic reactions and a potentially serious side effect called cytokine release syndrome The most common side effects of Hiltonol are reactions at the injection site and flu-like symptoms
A maximum of 36 patients with a newly diagnosed previously untreated WHO grade IV malignant glioma that is MGMT promoter unmethylated will be treated in this study after undergoing standard of care surgical resection followed by 6 weeks of radiation therapy XRT with concomitant temozolomide TMZ and providing informed consent Patients will receive seven P30 linked-EphA2 -CMV pp65 and -survivin P30-EPS peptide vaccines over two phases The first 5 will be given during the Priming Phase day 1 through day 22 The final 2 will be given during the Booster Phase day 84 2 days and day 140 2 days During the Booster Phase on Day 84 patients will also be given 20ugkg Hiltonol injections to administer at home every 2 weeks until they return on Day 140 Blood will be drawn throughout the study to investigate the immune response to P30-EPS vaccination The study will enroll two patient strata patients who are CMV seronegative and patients who are CMV seropositive Within each stratum cohorts of 3 patients will initially be accrued to the study to assess the toxicity associated with the vaccine The starting dose of P30-EPS is 300 μgpeptidedose and the dose will be escalated to 400 μgpeptidedose In the event of unacceptable dose-limiting toxicity the dose will be de-escalated to 200 μgpeptidedose dose level minus one Acute toxicity monitoring will focus on dose-limiting toxicities as defined in Section 912 of the protocol occurring between vaccine 1 and 30 days after vaccine 5 The most common side effects of peptide vaccines are redness or swelling at the injection site local changes to the texture of your skin hardening at the injection site itching allergic reactions and a potentially serious side effect called cytokine release syndrome The most common side effects of Hiltonol are reactions at the injection site and flu-like symptoms
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5P50CA190991 | NIH | None | httpsreporternihgovquickSearch5P50CA190991 |