Purpose of this Study
Patients will first get Td preconditioning and a medicine called temozolomide for 5 days. On day 21, they will get the study vaccine, PEP-CMV. The first 3 vaccines will be given every 2 weeks. After that, the vaccines will be given once a month. The first treatment cycle lasts 77 days, and all cycles after that last 28 days. To join the study, patients must have lab and clinical tests done within 7 days before starting. Lab results must be no more than 7 days old when therapy begins. If therapy starts within 7 days of the lab tests, the tests do not need to be repeated.
Who Can Participate?
Eligibility
Patients need to have a type of brain tumor called medulloblastoma that has come back, is getting worse, or did not respond to treatment. Doctors must confirm the tumor by looking at tissue samples either when the patient was first diagnosed or when the tumor returned.
Age Range
3-25
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
The study wants to learn three things:
1. How many patients with medulloblastoma can live at least 4 months without their tumor getting worse.
2. How many patients with DIPG live for 1 year after getting radiation and the PEP-CMV vaccine.
3. How many patients with HGG live for 1 year without their tumor getting worse after radiation and the PEP-CMV vaccine.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
CONNECT 1906: Phase 2 trial of a novel peptide vaccine (PEP-CMV) targeting CMV antigen for newly diagnosed pediatric high-grade glioma (HGG) and diffuse intrinsic pontine glioma (DIPG) and recurrent medulloblastoma (MB).
Principal Investigator
Daniel
Landi
Protocol Number
PRO00109336
NCT ID
NCT05096481
Phase
II
Enrollment Status
Open to Enrollment