PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma

  • STATUS
    Recruiting
  • End date
    Dec 28, 2023
  • participants needed
    30
  • sponsor
    Gary Archer Ph.D.
Updated on 30 May 2021
cancer
karnofsky performance status
x-rays
MRI
initial diagnosis
brain mri
chemoradiotherapy
neutrophil count
temozolomide
malignant glioma
recurrent tumor
medulloblastoma
montanide isa-51

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.

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.

Details
Condition Glioma, High Grade Glioma, Recurrent Medulloblastoma, Recurrent Brain Tumor, Childhood, Recurrent Brain Tumor, Childhood, Recurrent Brain Tumor, Childhood, Gliomas, Recurrent Brain Tumor, Childhood, Recurrent Brain Tumor, Childhood, Recurrent Brain Tumor, Childhood, Recurrent Brain Tumor, Childhood, Recurrent Brain Tumor, Childhood, Recurrent Brain Tumor, Childhood, Recurrent Brain Tumor, Childhood, Recurrent Brain Tumor, Childhood, malignant glioma, Recurrent Brain Tumor, Childhood, Recurrent Brain Tumor, Childhood, Recurrent Brain Tumor, Childhood
Treatment PEP-CMV
Clinical Study IdentifierNCT03299309
SponsorGary Archer Ph.D.
Last Modified on30 May 2021

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