CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
PEP-3 vaccine +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00643097
NCT00643097Phase 2Completed
CompareCT.gov

A Complementary Trial of an Immunotherapy Vaccine Against Tumor-Specific EGFRvIII

John Sampson·interventional·Posted Mar 26, 2008·Updated Feb 1, 2017

In Brief

A Phase 2 clinical trial evaluating PEP-3 vaccine, sargramostim, and 1 other intervention for Malignant Neoplasms of Brain. Completed, enrolled 40 participants across 2 sites.

Detailed Summary

RATIONALE: Vaccines made from a peptide may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with newly diagnosed glioblastoma multiforme.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Neoplasms of Brain
CountriesUnited States
CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS)

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 26, 2008
Enrollment StartSep 1, 2007
Primary CompletionJan 1, 2012
Study CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 18.3 years ago

Interventions

PEP-3 vaccinebiological

Given intradermally

sargramostimbiological

Given intradermally

Temozolomidedrug

Standard of care chemotherapy