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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01130077
Recruitment Status : Active, not recruiting
First Posted : May 25, 2010
Last Update Posted : October 25, 2022
Sponsor:
Collaborators:
Ellie Kavalieros Fund
Translational Brain Tumor Research Fund
Connor's Cure
Information provided by (Responsible Party):
Ian F. Pollack, M.D., University of Pittsburgh

Study Description
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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.

Condition or disease Intervention/treatment Phase
Newly Diagnosed Pediatric Pontine Glioma Newly Diagnosed Pediatric High Grade Glioma Recurrent Pediatric High Grade Glioma Recurrent Pediatric Low Grade Glioma Biological: HLA-A2 restricted glioma antigen peptides vaccine Biological: Poly-ICLC Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot study to assess tolerability of this vaccine regimen in different strata of children with high risk gliomas
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2009
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: HLA Restricted glioma antigen peptides plus Poly ICLC
All subjects will receive vaccine plus Poly ICLC will receive 9 injections ( once every 3 weeks)
 Biological: HLA-A2 restricted glioma antigen peptides vaccine
Vaccine given every 3 weeks
Other Name: BB13624

Biological: Poly-ICLC
Vaccine given every 3 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Safety: Tolerability during the first two vaccine courses as defined in the protocol. [ Time Frame: 6 weeks ]
    Tolerability during the first two vaccine courses as defined in the protocol.


Secondary Outcome Measures :
  1. Glioma-associated antigen-specific T-cell response [ Time Frame: Monitoring will continue as long as subject remains on study. ]
    Glioma-associated antigen-specific T-cell response: determined by IFN-gamma-enzyme linked immune spot (ELISPOT) and tetramer assays


Eligibility Criteria
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Ages Eligible for Study:   12 Months to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

**Inclusion Criteria

*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.
  • Patients must have life expectancy of at least 8 weeks.
  • Documented negative serum βHCG for female patients who are post-menarchal. Pregnant females will not be included in the study. Males and females must agree to use effective birth control methods during the course of vaccination.
  • Patients must be free of systemic infection.
  • Patients with adequate organ function as measured by: Bone marrow: ANC > 1,000/µl; Platelets > 100,000/µl (transfusion independent); absolute lymphocyte count of ≥500/uL; Hemoglobin >8 g/dl (may be transfused). Hepatic: bilirubin ≤ 1.5x institutional normal for age; SGPT (ALT) < 3x institutional normal.

Renal: Serum creatinine based on age or Creatinine clearance or radioisotope GFR >70 ml/min/ml/min/1.73 m²

  • Patients on Strata C and D must have recovered from the toxic effects of prior therapy: at least 3 weeks form the last dose of standard cytotoxic chemotherapy or myelosuppressive biological therapy and at least 1 week from the last dose of non-myelosuppressive biologic therapy.
  • No overt cardiac, gastrointestinal, pulmonary or psychiatric disease.

Exclusion Criteria:

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130077


Locations
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United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
Ian F. Pollack, M.D.
Ellie Kavalieros Fund
Translational Brain Tumor Research Fund
Connor's Cure
Investigators
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Principal Investigator: James Felker, MD University of Pittsburgh
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ian F. Pollack, M.D., Professor of Pediatrics, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01130077    
Obsolete Identifiers: NCT00862199
Other Study ID Numbers: STUDY19040319
PRO08030085 ( Other Identifier: Former identifier from University of Pittsburgh IRB )
First Posted: May 25, 2010    Key Record Dates
Last Update Posted: October 25, 2022
Last Verified: October 2022
Keywords provided by Ian F. Pollack, M.D., University of Pittsburgh:
Pediatric glioma
Vaccine therapy
Additional relevant MeSH terms:
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Glioma
Recurrence
Disease Attributes
Pathologic Processes
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Poly ICLC
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs