PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma

NCT03299309 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: Pro00079843
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Medulloblastoma; Recurrent Brain Tumor, Childhood; Malignant Glioma

Keywords

Glioma; Medulloblastoma; PRiME; Pro00079843; Thompson; Pediatric; Landi

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with unacceptable toxicity

  Evaluate the safety of PEP-CMV in pediatric patients with recurrent MB or recurrent Grade III/IV glioma

  2 weeks after the 3rd PEP-CMV vaccine on the last enrolled patient

Secondary Outcomes (2)

• Mean or median change from baseline at each follow-up assessment in ELISPOT (IFN-γ)

  24 months

• Mean or median change from baseline at each follow-up assessment in ELISA (gB-KLH)

  24 months

Study Arms (1)

PEP-CMV

EXPERIMENTAL

Cytomegalovirus (CMV)-specific peptide vaccine (PEP-CMV)

Drug: PEP-CMV

Interventions

PEP-CMV DRUG

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.

Also known as: PEP-CMV vaccine

PEP-CMV

Eligibility Criteria

• Age: 3 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients who are 3 - 35 years old
• Histopathologically proven previous diagnosis of medulloblastoma or Grade III or IV glioma.
• Radiology evidence of recurrent medulloblastoma (reMB) or recurrent Grade III and IV glioma. Patients will be considered for a biopsy or resection of the recurrent/progressive tumor at the discretion of the treating neurosurgeon and neuro-oncologist.
• Brain MRI within one month prior to enrollment.
• Received prior therapy for their initial diagnosis prior to recurrence/progression or who are unable to receive radiation therapy due to genetic disorders that put them at significant risk for radiation-induced secondary malignancies (i.e. Gorlin's syndrome or NF1 mutation).
• Patients with neurological deficits should have deficits that are stable for a minimum of 2 weeks prior to registration.
• Karnofsky Performance Status (KPS) of ≥ 60% (KPS for \> 10 years of age) or Lansky performance Score (LPS) of ≥ 60 (LPS for ≤ 10 years of age) assessed within 2 weeks prior to registration. Patients who are unable to walk because of paralysis but who are up in a wheel chair will be considered ambulatory for the purposes of the performance score.
• Bone Marrow:
• ANC (Absolute neutrophil count) ≥ 1000/µl (unsupported)\*.
• Platelets ≥ 100,000/µl (unsupported)\*.
• Hemoglobin \> 8 g/dL (may be supported).
• Renal:
• Serum creatinine ≤ upper limit of institutional normal.
• Hepatic:
• Bilirubin ≤ 1.5 times upper limit of normal for age.

You may not qualify if:

• Pregnant or need to breast feed during the study period (Negative serum pregnancy test required).
• Active infection requiring treatment or an unexplained febrile (\> 101.5 degrees F) illness.
• Known immunosuppressive disease or human immunodeficiency virus infection.
• Patients with active renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), or pulmonary disease.
• Patients receiving concomitant immunosuppressive agents for medical condition.
• Patients who need definitive radiotherapy for treatment of recurrent MB or recurrent Grade III or IV glioma.
• Patients receiving any other investigational drug therapy.
• Patients on corticosteroids \> 0.1 mg/Kg/day (i.e. \> the maximum dose of 4 mg/day).
• Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction).
• Patients with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy.

Sponsors & Collaborators

• Daniel Landi: lead
• Pediatric Brain Tumor Foundation: collaborator
• Annias Immunotherapeutics, Inc.: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Links

• The Preston Robert Tisch Brain Tumor Center at Duke
• Duke Cancer Institute

MeSH Terms

Conditions

Medulloblastoma; Brain Neoplasms; Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors, Primitive; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Daniel Landi, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics and Neurosurgery

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 3, 2017
• Study Start: June 29, 2018
• Primary Completion: April 27, 2023
• Study Completion: April 1, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)