Clinical Research Directory
Browse clinical research sites, groups, and studies.
PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma
Sponsor: Daniel Landi
Summary
The primary goal of this prospective clinical trial is to evaluate the safety of PEP-CMV in patients with recurrent medulloblastoma and malignant glioma. Patients with histologically-proven medulloblastoma or malignant glioma who had received prior therapy for their initial diagnosis and subsequently had tumor recurrence/progression may be enrolled any time after recurrence/progression regardless of prior adjuvant therapy. PEP-CMV is a vaccine comprised of Component A, a synthetic long peptide (SLP) of 26 amino acid residues from human pp65. In May 2021, enrollment on the study was temporarily suspended due to delays in vialing the PEP-CMV study vaccine.
Official title: The PRiME Study: PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma
Key Details
Gender
All
Age Range
3 Years - 35 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2018-06-29
Completion Date
2026-04
Last Updated
2025-07-09
Healthy Volunteers
No
Interventions
PEP-CMV
Patients receive temozolomide (TMZ) 200 mg/m2/day x 5 days. On day 20, patients will receive a Tetanus-diphtheria pre-conditioning vaccination with Td (tetanus, diphtheria toxoid, adsorbed). Immunotherapy begins the following day, on day 21, with injection of the PEP-CMV vaccine as follows: PEP-CMV Component A mixed with Montanide ISA-51 intradermally administered half in the RIGHT groin and half in the LEFT groin.
Locations (1)
Duke University Medical Center
Durham, North Carolina, United States