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ACTIVE NOT RECRUITING
NCT03299309
PHASE1

PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma

Sponsor: Daniel Landi

View on ClinicalTrials.gov

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

DRUG

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