Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioma

Disease Attributes

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

All Drugs and Chemicals

Anti-Infective Agents

Antineoplastic Agents

Vaccines

Poly ICLC

Interferons

Immunologic Factors

All subjects will receive vaccine plus Poly ICLC will receive 9 injections ( once every 3 weeks)

HLA-A2 restricted glioma antigen peptides vaccine

Poly-ICLC

James Felker, MD

The overall objective of this pilot study is to collect immunological and safety data following administration of vaccinations with HLA-A2. This data will be used to decide whether a larger study of clinical efficacy is warranted.

Pilot study to assess tolerability of this vaccine regimen in different strata of children with high risk gliomas

A Pilot Study of Glioma Associated Antigen Vaccines in Conjunction With Poly-ICLC in Pediatric Gliomas

A Pilot Study to Evaluate the Effects of Vaccinations With HLA-A2-Restricted Glioma Antigen-Peptides With Poly-ICLC for Children With Newly Diagnosed Malignant Brain Stem Gliomas, Non-Brainstem High-Grade Gliomas, Recurrent Low-Grade Gliomas or Recurrent High Grade Gliomas

Tolerability during the first two vaccine courses as defined in the protocol.

Glioma-associated antigen-specific T-cell response: determined by IFN-gamma-enzyme linked immune spot (ELISPOT) and tetramer assays

Ellie Kavalieros Fund

Translational Brain Tumor Research Fund

Connor's Cure

James Felker

Assistant Professor

Nervous System Diseases

Diffuse Intrinsic Pontine Glioma

Brain Stem Neoplasms

Infratentorial Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Everolimus

Panobinostat

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Histone Deacetylase Inhibitors

Panobinostat daily M, W, F for 2 weeks every 28 days for the first cycle (28 days). After first cycle Panobinostat daily M, W, F for 2 weeks every 28 days combined with Everolimus daily.

Carl Koschmann, MD

This phase 2 trial will evaluate the activity of Panobinostat in combination with Everolimus for children with gliomas harboring H3.1 or H3.3K27M mutation, including newly diagnosed high-grade glioma or DIPG (diffuse intrinsic pontine glioma) after radiation (stratum A) and recurrent/progressive glioma (grade II-IV, including DIPG) (stratum B).

Patients will be divided into two stratums; newly diagnosed high-grade glioma or DIPG after radiation (stratum A) and recurrent/progressive glioma (grade II-IV, including DIPG) (stratum B).

A Study of Panobinostat in Combination With Everolimus for Children and Young Adults With Gliomas

A Phase 2 Study of Panobinostat in Combination With Everolimus for Children and Young Adults With Gliomas Harboring H3.3 or H3.1 K27M Mutation

Median PFS at 1 year for stratum A will be measured. Progression is defined as \> 25% increase in the size of the tumor or appearance of new lesions.

The proportion of patients alive at 1 year for stratum A.

The proportion of patients alive at 2 years for stratum A.

Overall Response Rate (ORR) After Two Cycles of Panobinostat + Everolimus for stratum B. Overall response is defined as a partial or complete response. Partial response is defined as a ≥50% decrease in size of tumor in comparison to baseline measurements. Complete response is defined as the disappearance of all abnormal signal. This includes return to normal size of the brainstem for brainstem lesions.

University of Michigan Rogel Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Pilot Study of Glioma Associated Antigen Vaccines in Conjunction With Poly-ICLC in Pediatric Gliomas	NCT01130077	Newly Diagnosed... Newly Diagnosed... Recurrent Pedia... Recurrent Pedia...	HLA-A2 restrict... Poly-ICLC	12 Months - 21 Years	University of Pittsburgh
A Study of Panobinostat in Combination With Everolimus for Children and Young Adults With Gliomas	NCT03632317	Glioma Diffuse Intrins...	Panobinostat Everolimus	2 Years - 30 Years	University of Michigan Rogel Cancer Center

Spots Global Cancer Trial Database for pediatric glioma