NCT01400672

Imiquimod/Brain Tumor Initiating Cell (BTIC) Vaccine in Brain Stem Glioma

Terminated Phase 1 Last updated 18 March 2020

What this trial tests

Phase 1 trial testing Tumor Lysate Vaccine in Diffuse Intrinsic Pontine Glioma in 8 participants. Terminated before completion.

Timeline

17 July 2012

Primary endpoint
7 March 2016

8 October 2018

Quick facts

Lead sponsor	Masonic Cancer Center, University of Minnesota
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	17 July 2012
Primary completion	7 March 2016
Estimated completion	8 October 2018
Sites	1 location across United States

Drugs / interventions tested

• Tumor Lysate Vaccine — full drug profile →
• Imiquimod (IMIQUIMOD) — full drug profile →
• Radiation therapy — full drug profile →

Conditions studied

• Diffuse Intrinsic Pontine Glioma — all drugs for Diffuse Intrinsic Pontine Glioma →

Sponsor

Masonic Cancer Center, University of Minnesota

Who can join

3 and older, any sex, with Diffuse Intrinsic Pontine Glioma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a pilot/feasibility study. The study design represents a modification of current standard of care for Diffuse Intrinsic Pontine Glioma (DIPG) (5580 cGY involved field radiation), with the final two doses of radiation given at intervals during the vaccination phase of treatment.

Patients between the ages of 3 years and 25 years diagnosed with Diffuse Intrinsic Pontine Glioma (DIPG) will be allowed to participate in the trial. Study enrollment will occur after the completion of conformal radiation therapy to a dose of 5580 cGy and the post radiation therapy (RT) magnetic resonance imaging (MRI) shows no disease progression.

Three patients with glioblastoma multiforme, aged 16 years and older, will be entered first to confirm vaccine safety before enrolling DIPG patients.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. A highlight on Sonic hedgehog pathway.
   Carballo GB, Honorato JR, de Lopes GPF, Spohr TCLSE. · · 2018 · cited 321× · PMID 29558958 · DOI 10.1186/s12964-018-0220-7
2. Pediatric high-grade glioma: biologically and clinically in need of new thinking.
   Jones C, Karajannis MA, Jones DTW, Kieran MW, et al · · 2017 · cited 288× · PMID 27282398 · DOI 10.1093/neuonc/now101
3. Combinations of immunotherapy and radiation in cancer therapy.
   Vatner RE, Cooper BT, Vanpouille-Box C, Demaria S, et al · · 2014 · cited 189× · PMID 25506582 · DOI 10.3389/fonc.2014.00325
4. Trial watch: FDA-approved Toll-like receptor agonists for cancer therapy.
   Vacchelli E, Galluzzi L, Eggermont A, Fridman WH, et al · · 2012 · cited 178× · PMID 23162757 · DOI 10.4161/onci.20931
5. Advances in Glioblastoma Therapy: An Update on Current Approaches.
   Angom RS, Nakka NMR, Bhattacharya S. · · 2023 · cited 140× · PMID 38002496 · DOI 10.3390/brainsci13111536
6. Trial Watch: Toll-like receptor agonists for cancer therapy.
   Vacchelli E, Eggermont A, Sautès-Fridman C, Galon J, et al · · 2013 · cited 127× · PMID 24083080 · DOI 10.4161/onci.25238
7. The adaptive transition of glioblastoma stem cells and its implications on treatments.
   Wang Z, Zhang H, Xu S, Liu Z, et al · · 2021 · cited 101× · PMID 33753720 · DOI 10.1038/s41392-021-00491-w
8. Trial Watch: Immunostimulation with Toll-like receptor agonists in cancer therapy.
   Iribarren K, Bloy N, Buqué A, Cremer I, et al · · 2016 · cited 98× · PMID 27141345 · DOI 10.1080/2162402x.2015.1088631