NCT03299309

PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma

The PRiME Study: PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Daniel Landi · Academic / Other
• Sex: All
• Age: 3 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Once a patient has enrolled onto this study, prior therapy will be terminated and patients will receive temozolomide 200 mg/m2/day x 5 days. If they are receiving bevacizumab at the time of enrollment, they will continue bevacizumab 10 mg/Kg every 14 days. Patients who are ≥ 18 years of age will receive a tetanus (Td) booster at the time of enrollment. Immunotherapy begins with a Tetanus (Td) pre-conditioning vaccine delivered intradermally (i.d.) in the right groin at the site of the vaccine injection 6-24 hours prior to the first vaccine on day 21. The PEP-CMV vaccine will be administered as follows: PEP-CMV Component A mixed with Montanide ISA-51 (1:1 volume ratio) intradermally administered half in the RIGHT groin and half in the LEFT groin. The first 3 PEP-CMV vaccines will occur every 2 weeks, then PEP-CMV vaccines will continue monthly (+/- 2 weeks) for no more than 10 years. Blood will be obtained for immune system monitoring. 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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-06-29
• Primary completion: 2023-04-27
• Completion: 2026-04-01
• First posted: 2017-10-03
• Last updated: 2025-07-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study