RECRUITING

rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG

Conditions

Diffuse Intrinsic Pontine Glioma Diffuse Midline Glioma, H3 K27M-Mutant Immunotherapy Cancer vaccine Checkpoint blockade DIPG High grade glioma DMG Diffuse midline glioma rHSC-DIPGVax Balstilimab Zalifrelimab

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a phase I, open label, plus expansion clinical trial evaluating the safety and tolerability of rHSC-DIPGVax in combination with BALSTILIMAB and ZALIFRELIMAB. rHSC-DIPGVax is an off-the-shelf neo-antigen heat shock protein containing 16 peptides reflecting neo-epitopes found in the majority of DIPG and DMG tumors. Newly diagnosed patients with DIPG and DMG who have completed radiation six to ten weeks prior to enrollment are eligible.

Official Title

A Phase I Clinical Trial of Neo-antigen Heat Shock Protein Vaccine (rHSC-DIPGVax) in Combination With Checkpoint Blockade for the Treatment of Diffuse Intrinsic Pontine Glioma (DIPG) and Diffuse Midline Glioma in Childhood

Quick Facts

Study Start:2022-01-10

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04943848

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Months to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Subjects with newly diagnosed typical or non-typical, biopsy-proven DIPG or DMG are eligible for study enrollment. Biopsy is not required for subjects with radiographically typical DIPG meeting imaging criteria. Biopsy is required for DMG's and non-radiographically typical DIPG. Histone mutation must be confirmed by pathology report. Radiographically typical DIPG defined as a tumor with a pontine epicenter and diffuse involvement of more than 2/3 of the pons. * BSA \> or = 0.35m2 at the time of study enrollment * Performance score: Karnofsky \>50% of subjects \>16 years of age and Lansky \> or = 50 for subjects \< or = 16 years of age. Subjects who are unable to walk because of paralysis but are up in a wheelchair will be considered ambulatory for the purpose of assessing the performance score. * Must start radiation therapy within 42 days from date of diagnostic imaging. C1D1 must be within 42 days to 70 days post radiation (6-10 weeks). Patients CANNOT receive temozolomide during radiation * Corticosteroids should be weaned as tolerated after radiation therapy with the goal of \< or = 0.5mg/kg/day for a minimum of 7 days prior to enrollment. * Subjects must have measurable disease	* Patients cannot receive temozolomide during radiation * Disseminated disease * Subjects who have received any cancer therapy except for radiation * Autoimmune or immune disorders * Active respiratory disorder or infection * Active viral infection

Inclusion Criteria

Exclusion Criteria

* Subjects with newly diagnosed typical or non-typical, biopsy-proven DIPG or DMG are eligible for study enrollment. Biopsy is not required for subjects with radiographically typical DIPG meeting imaging criteria. Biopsy is required for DMG's and non-radiographically typical DIPG. Histone mutation must be confirmed by pathology report. Radiographically typical DIPG defined as a tumor with a pontine epicenter and diffuse involvement of more than 2/3 of the pons.
* BSA \> or = 0.35m2 at the time of study enrollment
* Performance score: Karnofsky \>50% of subjects \>16 years of age and Lansky \> or = 50 for subjects \< or = 16 years of age. Subjects who are unable to walk because of paralysis but are up in a wheelchair will be considered ambulatory for the purpose of assessing the performance score.
* Must start radiation therapy within 42 days from date of diagnostic imaging. C1D1 must be within 42 days to 70 days post radiation (6-10 weeks). Patients CANNOT receive temozolomide during radiation
* Corticosteroids should be weaned as tolerated after radiation therapy with the goal of \< or = 0.5mg/kg/day for a minimum of 7 days prior to enrollment.
* Subjects must have measurable disease

* Patients cannot receive temozolomide during radiation
* Disseminated disease
* Subjects who have received any cancer therapy except for radiation
* Autoimmune or immune disorders
* Active respiratory disorder or infection
* Active viral infection

Contacts and Locations

Study Contact

Monica Newmark, BS, RN

CONTACT

312-227-4847

MNewmark@luriechildrens.org

Ashley Plant-Fox, MD

CONTACT

312-227-4858

aplant@luriechildrens.org

Principal Investigator

Ashley Plant-Fox, MD

PRINCIPAL_INVESTIGATOR

Ann and Robert H. Lurie Children's Hospital

Study Locations (Sites)

Children's Health Orange County (CHOC)

Orange, California, 92868

United States

Ann and Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611

United States

Dana-Farber Boston Children's Cancer and Blood Disorders Center

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Ashley Plant-Fox, MD, PRINCIPAL_INVESTIGATOR, Ann and Robert H. Lurie Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-10

Study Completion Date2025-12

Study Record Updates

Study Start Date2022-01-10

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

Immunotherapy
Cancer vaccine
Checkpoint blockade
DIPG
Diffuse intrinsic pontine glioma
High grade glioma
DMG
Diffuse midline glioma
rHSC-DIPGVax
Balstilimab
Zalifrelimab

Additional Relevant MeSH Terms

Diffuse Intrinsic Pontine Glioma
Diffuse Midline Glioma, H3 K27M-Mutant