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

NCT01130077 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: STUDY19040319PRO08030085
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Newly Diagnosed Pediatric Pontine Glioma; Newly Diagnosed Pediatric High Grade Glioma; Recurrent Pediatric High Grade Glioma; Recurrent Pediatric Low Grade Glioma

Keywords

Pediatric glioma; Vaccine therapy

Outcome Measures

Primary Outcomes (1)

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

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

  6 weeks

Secondary Outcomes (1)

• Glioma-associated antigen-specific T-cell response

  Monitoring will continue as long as subject remains on study.

Study Arms (1)

HLA Restricted glioma antigen peptides plus Poly ICLC

EXPERIMENTAL

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

Biological: HLA-A2 restricted glioma antigen peptides vaccine; Biological: Poly-ICLC

Interventions

HLA-A2 restricted glioma antigen peptides vaccine BIOLOGICAL

Vaccine given every 3 weeks

Also known as: BB13624

HLA Restricted glioma antigen peptides plus Poly ICLC

Poly-ICLC BIOLOGICAL

Vaccine given every 3 weeks

HLA Restricted glioma antigen peptides plus Poly ICLC

Eligibility Criteria

• Age: 12 Months - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \*Tumor Types - Tumor type/location:
• Stratum A: Newly diagnosed diffuse intrinsic pontine gliomas OR any biopsy proven high-grade glioma\* involving the brainstem. Patients may not have received chemotherapy during or after radiation. (Note: Stratum A is closed to accrual.)
• Stratum B: Newly diagnosed, non-brainstem high-grade glioma\* Patients may not have received chemotherapy during or after radiation. (Note: Stratum B is open to accrual.)
• Stratum C: Unresectable low-grade gliomas that have received at least two chemotherapy/biologic regimens. Patients may not have received radiation to the index lesion within 1 year of enrollment. (Note: Stratum C is closed to accrual.)
• Stratum D: Non-brainstem high-grade gliomas\* that have recurred following treatment. (Note: Stratum D is closed to accrual.)
• Stratum E: Newly diagnosed high-grade gliomas\* or brain stem gliomas who received chemotherapy during radiation therapy. Patients may not have received chemotherapy after radiation therapy was completed. (Note: Stratum E is closed to accrual.)
• Stratum F: Newly diagnosed high-grade gliomas with metastatic disease within the CNS requiring craniospinal radiation therapy. Patients may or may not have received chemotherapy during radiation, but cannot have received chemotherapy after radiation therapy was completed. (Note: Stratum F is closed to accrual.)
• Eligible histologies include glioblastoma (GBM), anaplastic astrocytoma (AA) or gliosarcoma. Patients with any oligodendroglioma component are NOT eligible.
• HLA-A2 positive based on flow cytometry.
• Patients in Stratum A B and E must have received standard involved field radiation therapy \[RT\] defined as fractionated external beam radiotherapy with total doses between 5000-6000 cGy. Patients in these strata must be registered within 4-12 weeks of completing RT.
• Patients in Stratum F must have received craniospinal radiation.
• Patients must be clinically stable and off or on low-dose (no more than 0.1 mg/kg/day, max 4 mg/day Dexamethasone) corticosteroid for at least one week prior to study registration.
• All patients must sign an IRB-approved informed consent document
• Patients must be ≥ 12 months and \<22 years of age at the time of study registration.
• Patients must have a performance status of ≥ to 60.

You may not qualify if:

• Patients living outside of North America are not eligible.
• Presence of metastatic disease for patients in Stratum A, B, D and E. Patients with low grade gliomas (stratum C) may have tumor spread within the CNS.
• Patients in Stratum F must have tumor spread within the CNS.
• Patients enrolled in Strata A and B may not have received any prior chemotherapy or anti-glioma therapy of any type other than radiation therapy. Patients enrolled on stratum C must have received at least two prior chemotherapy or biologic therapy regimens and may not have received radiation to the index lesion within 1 year of enrollment. Patients on Strata A, B, E, and F can not have received chemotherapy after radiation therapy was completed.
• Concurrent treatment or medications (must be off for at least 1 week) including:
• Interferon (e.g. Intron-A®)
• Allergy desensitization injections
• Growth factors (e.g. Procrit®, Aranesp®, Neulasta®)
• Interleukins (e.g. Proleukin®)
• Any investigational therapeutic medication
• Patients must not have a history of, or currently active autoimmune disorders.
• Use of immunosuppressives within four weeks prior to study entry. Dexamethasone, or other corticosteroid medications, if used in the peri-operative period and/or during radiotherapy, must be tapered (no more than 0.1 mg/kg/day, max 4 mg/day dexamethasone) for at least one week before study registration. Topical corticosteroids are acceptable.
• Patients with known addiction to alcohol or illicit drugs.

Sponsors & Collaborators

• James Felker: lead
• Ellie Kavalieros Fund: collaborator
• Translational Brain Tumor Research Fund: collaborator
• Connor's Cure: collaborator

Study Sites (1)

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (2)

• Pollack IF, Jakacki RI, Butterfield LH, Hamilton RL, Panigrahy A, Potter DM, Connelly AK, Dibridge SA, Whiteside TL, Okada H. Antigen-specific immune responses and clinical outcome after vaccination with glioma-associated antigen peptides and polyinosinic-polycytidylic acid stabilized by lysine and carboxymethylcellulose in children with newly diagnosed malignant brainstem and nonbrainstem gliomas. J Clin Oncol. 2014 Jul 1;32(19):2050-8. doi: 10.1200/JCO.2013.54.0526. Epub 2014 Jun 2.

  PMID: 24888813 DERIVED

• Robison NJ, Kieran MW. Diffuse intrinsic pontine glioma: a reassessment. J Neurooncol. 2014 Aug;119(1):7-15. doi: 10.1007/s11060-014-1448-8. Epub 2014 May 3.

  PMID: 24792486 DERIVED

MeSH Terms

Interventions

poly ICLC

Study Officials

• James Felker, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

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

Study Record Dates

• First Submitted: May 24, 2010
• First Posted: May 25, 2010
• Study Start: February 1, 2009
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: December 6, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)