Health Trials

About this trial

This study will address the question of whether targeting CMV antigens with PEP-CMV can serve as a novel immunotherapeutic approach in pediatric patients with newly-diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG) as well as recurrent medulloblastoma (MB).

PEP-CMV is a vaccine mixture of a peptide referred to as Component A. Component A is a synthetic long peptide (SLP) of 26 amino acid residues from human pp65. The SLPs encode multiple potential class I, class II, and antibody epitopes across several haplotypes. Component A will be administered as a stable water:oil emulsion in Montanide ISA 51.

Funding Source - FDA OOPD

Eligibility criteria

Qualifiers

Age: Patients must be ≥3 and ≤39 years of age at the time of study enrollment

Diagnosis: Patients must have a diagnosis of medulloblastoma that is recurrent, progressive or refractory. All patients must have histological verification of a medulloblastoma, at original diagnosis or relapse.

Metastatic Disease: Patients with M+ disease are eligible.

Radiotherapy: prior radiotherapy requirements Patients must have received prior disease-directed therapy including radiotherapy for their initial diagnosis of medulloblastoma unless patients are less than 4 years of age at the time of enrollment.

Disqualifiers

Pregnant or breast-feeding women will not be entered on this study due to known or unknown risks of fetal and teratogenic adverse events as seen in animal/human studies. Pregnancy tests must be obtained in girls who are post-monarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.

Pregnancy Prevention Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study and for 3 months after drug cessation.

Active infection requiring treatment

Patients with malignancy related to HIV or solid organ transplant: known history of HIV, HBV surface antigen positivity or positive HCV antibody are not eligible. Viral testing is not required unless clinically indicated in patients without a known history

Trial design

Treatments tested in this trial

  • PEP-CMV
  • Temozolomide
  • Tetanus Diphtheria Vaccine

Treatment groups

120 Participants
are divided into 1 treatment group

Locations

13
Colorado
Children's Hospital Colorado80045, Aurora United States
District of Columbia
Children's National Medical Center20010, Washington D.C. United States
Florida
Nicklaus Children's Hospital33155, Miami United States
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago60611, Chicago United States

Sponsors and collaborators

Nationwide Children's Hospital

Lead sponsor

Duke University

Collaborator

Source ClinicalTrials.gov