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PEP-CMV Vaccine Targeting CMV Antigen to Treat Newly Diagnosed Pediatric HGG and DIPG and Recurrent Medulloblastoma

ConditionsHigh Grade GliomaDiffuse Intrinsic Pontine GliomaRecurrent Medulloblastoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age3-39
SponsorNationwide Children's Hospital

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • PEP-CMV

    Biological/Vaccine

    The PEP-CMV vaccine will be administered as follows: 250 µg/m2 (up to a maximum of 500 µg) of Component A mixed with Montanide ISA-51 (1:1 volume ratio) intradermally administered half in the RIGHT groin and half in the LEFT groin.

  • Temozolomide

    Drug

    Patients will receive one course of temozolomide 200 mg/m2/day x 5 days on Days 1-5 of cycle 1

  • Tetanus Diphtheria Vaccine

    Biological/Vaccine

    Patients will receive a tetanus (Td) booster (Td 5 flocculation units, Lf) at the time of enrollment. Immunotherapy begins with a Td pre-conditioning vaccine (Td 1 Lf, in 0.4 mL of saline) delivered i.d. at the RIGHT groin site of the vaccine injection 6-24 hours prior to the first vaccine on day 21.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: PEP-CMVExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

4-mo PFS in patients with recurrent medulloblastoma

To determine the progression-free survival (PFS) at 4 months in pediatric or young adult patients with recurrent medulloblastoma treated with PEP-CMV.

Time frame
4 months
2

1-yr OS in patients with newly diagnosed DIPG

To estimate the 1-year Overall Survival (OS) distribution in patients with newly diagnosed DIPG treated with radiotherapy followed by PEP-CMV

Time frame
one year
3

1-yr PFS in patients with newly diagnosed HGG

To estimate the 1-year Progression Free Survival (PFS) distribution in patients with newly diagnosed HGG treated with radiotherapy followed by PEP-CMV

Time frame
one year

Secondary outcomes

1

ORR in patients with recurrent medulloblastoma

To determine the objective response rate (ORR) = partial response (PR) + complete response (CR) in patients with recurrent medulloblastoma treated with PEP-CMV

Time frame
From Day 1 of treatment through 30 days following end of protocol treatment
2

PFS in patients with recurrent medulloblastoma

To determine the 1-year Progression Free Survival (PFS) in patients with recurrent Medulloblastoma treated with PEP-CMV.

Time frame
one year
3

OS in patients with newly diagnosed HGG by PEP-CMV

To determine the 2-year Overall Survival (OS) in patients newly diagnosed with HGG treated with PEP-CMV.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nationwide Children's Hospital

Lead sponsor

Duke University

Collaborator

Source ClinicalTrials.gov
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