Clinical Trials /

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

NCT01130077

Description:

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.

Related Conditions:
  • Glioma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

A Pilot Study of <span class="go-doc-concept go-doc-disease">Glioma</span> Associated Antigen Vaccines in Conjunction With <span class="go-doc-concept go-doc-intervention">Poly-ICLC</span> in Pediatric Gliomas

Title

  • Brief Title: A Pilot Study of Glioma Associated Antigen Vaccines in Conjunction With Poly-ICLC in Pediatric Gliomas
  • 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
  • Clinical Trial IDs

    NCT ID: NCT01130077

    NCT Alias ID: NCT00862199

    ORG ID: PRO08030085

    Trial Conditions

    Newly Diagnosed Pediatric Pontine Glioma.

    Newly Diagnosed Pediatric High Grade Glioma.

    Recurrent Pediatric High Grade Glioma.

    Recurrent Pediatric Low Grade Glioma.

    Trial Interventions

    Drug Synonyms Arms

    Trial 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.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    HLA Restristed glioma antigen peptides plus Poly ICLC Experimental All subjects will receive vaccine plus Poly ICLC will receive 9 injections ( once every 3 weeks)

    Eligibility 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 open 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 HCG 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/l;
    Platelets > 100,000/l (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 m

    - 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.

    Minimum Eligible Age: 12 Months

    Maximum Eligible Age: 21 Years

    Eligible Gender: Both

    Primary Outcome Measures

    Safety

    Secondary Outcome Measures

    Glioma-associated antigen-specific T-cell response

    Trial Keywords

    Pediatric glioma

    Vaccine therapy