Peptide Targets for Glioblastoma Against Novel Cytomegalovirus Antigens
Status:
Active, not recruiting
Trial end date:
2021-09-01
Target enrollment:
Participant gender:
Summary
Newly diagnosed glioblastoma (GBM) patients with complete or partial surgical resection who
are CMV seropositive patients will be eligible to enroll on this trial. Patients will be
enrolled following standard of care chemoradiation and prior to initiation of post-radiation
cycles of temozolomide (TMZ) provided they meet all eligibility criteria. Eligible patients
will receive a tetanus-diphtheria (Td) vaccination. Patients will then be randomized to one
of two arms of the study: Arm 1 will received standard TMZ and Arm 2 will receive
dose-intensified TMZ. All patients will receive a pre-conditioning injection of tetanus on
day 22 of the first post-radiation cycle of TMZ. The following day, patients will receive the
first of 3 intradermal (i.d.) injections of the study drug cytomegalovirus peptide (PEP-CMV),
which contains what is referred to as Component A. Vaccines #2 and #3 will be given at 2 week
intervals. Patients who are MGMT (O[6]-methylguanine-DNA methyltransferase) unmethylated will
receive one adjuvant cycle of the TMZ regimen according to their assigned randomized arm.
Patients who are MGMT methylated or whose methylation status is inconclusive will continue
with up to 12 cycles of TMZ. After the completion of a patient's last TMZ cycle, vaccines
will continue every 4-6 weeks for a maximum number of 20 vaccines (unless tumor progression
occurs).
Phase:
Phase 1
Details
Lead Sponsor:
Gary Archer Ph.D.
Collaborators:
Annias Immunotherapeutics, Inc. National Cancer Institute (NCI) National Institutes of Health (NIH)