MedTrace Logo

Peptide Vaccine for Glioblastoma Against Cytomegalovirus Antigens

NCT01854099 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2014-01-14

No results posted yet for this study

Summary

Eligible adult patients with new diagnosis of gliobastoma are enrolled to receive 3 weekly vaccinations of the study drug PEP-CMV 1-3 days following standard of care chemoradiation. Patients will then be randomized to one of three arms: 1). standard temozolomide (TMZ)(200mg/m\^2 for 5 days) with vaccine on day 6-8 of each monthly TMZ cycle. 2). standard TMZ (200mg/m\^2 for 5 days) with vaccine on day 22-24 of each monthly TMZ cycle. 3). dose-intensified TMZ (100 mg./m\^2 for 21 days) with vaccine on day 22-24 of each monthly cycle. All vaccines will be given intradermally (i.d.) and will be given with monthly TMZ cycles and continue after TMZ cycles until progression or death.

Conditions

Interventions

BIOLOGICAL

PEP-CMV

500 µg of PEP-CMV vaccine given intradermally on day 6-8 of each monthly TMZ cycle (standard 200 mg/m\^2 x 5 days) with group 1.

BIOLOGICAL

PEP-CMV

500 µg of PEP-CMV vaccine given intradermally on day 22-24 of each monthly TMZ cycle (standard 200 mg/m\^2 x 5 days) with group 2.

BIOLOGICAL

PEP-CMV

500 µg of PEP-CMV vaccine given intradermally on day 22-24 of each monthly TMZ cycle (dose-intensified 100 mg/m\^2 x 21 days) with group 3.

Sponsors & Collaborators

  • American Brain Tumor Association

    collaborator OTHER

  • University of Florida

    lead OTHER

Principal Investigators

  • Duane A Mitchell, MD, PhD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-01-31
Completion
2014-01-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01854099 on ClinicalTrials.gov