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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by University of Pittsburgh
Sponsor:
Collaborators:
Ellie Kavalieros Fund
Translational Brain Tumor Research Fund
Information provided by (Responsible Party):
Ian F. Pollack, M.D., University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01130077
First received: May 24, 2010
Last updated: March 20, 2015
Last verified: March 2015
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Safety [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Tolerability during the first two vaccine courses as defined in the protocol.


Secondary Outcome Measures:
  • Glioma-associated antigen-specific T-cell response [ Time Frame: Monitoring will continue as long as subject remains on study. ] [ Designated as safety issue: No ]
    Glioma-associated antigen-specific T-cell response: determined by IFN-gamma-enzyme linked immune spot (ELISPOT) and tetramer assays


Estimated Enrollment: 60
Study Start Date: February 2009
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HLA Restristed 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

  Eligibility

Ages Eligible for Study:   12 Months to 21 Years
Genders Eligible for Study:   Both
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.

Stratum B: Newly diagnosed, non-brainstem high-grade glioma* Patients may not have received chemotherapy during or after radiation.

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.

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.

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.

  • 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01130077

Contacts
Contact: Gary Mason, MD 412 692-5055

Locations
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Angela Connelly, RN    412-692-8047    angela.krol@chp.edu   
Sponsors and Collaborators
University of Pittsburgh
Ellie Kavalieros Fund
Translational Brain Tumor Research Fund
Investigators
Principal Investigator: Gary Mason, MD Children's Hospital of Pittsburgh of UPMC
  More Information

No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ian F. Pollack, M.D., Professor of Pediatrics, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01130077     History of Changes
Obsolete Identifiers: NCT00862199
Other Study ID Numbers: PRO08030085
Study First Received: May 24, 2010
Last Updated: March 20, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
Pediatric glioma
Vaccine therapy

Additional relevant MeSH terms:
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Poly ICLC
Immunologic Factors
Interferon Inducers
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2015