Clinical Trials /

A Vaccine Trial for Low Grade Gliomas

NCT02358187

Description:

The study will assess the immunogenicity, safety and preliminary clinical efficacy of the GAA/TT-peptide vaccine and poly-ICLC in HLA-A2+ children with unresectable low-grade gliomas that have received at least two chemotherapy/biologic regimens. Radiation therapy counts as one biologic regimen, but patients may not have received radiation to the index lesion within 1 year of enrollment.

Related Conditions:
  • Glioma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

A Vaccine Trial for Low Grade Gliomas

Title

  • Brief Title: A Vaccine Trial for Low Grade Gliomas
  • Official Title: A Phase II Study of Vaccinations With HLA-A2 Restricted Glioma Antigen Peptides in Combination With Poly-ICLC for Children With Recurrent Unresectable Low-Grade Gliomas (LGG)
  • Clinical Trial IDs

    NCT ID: NCT02358187

    ORG ID: PRO1310086

    NCI ID: R01CA187219

    Trial Conditions

    Low Grade Glioma

    Trial Interventions

    Drug Synonyms Arms

    Trial Purpose

    The study will assess the immunogenicity, safety and preliminary clinical efficacy of the
    GAA/TT-peptide vaccine and poly-ICLC in HLA-A2+ children with unresectable low-grade gliomas
    that have received at least two chemotherapy/biologic regimens. Radiation therapy counts as
    one biologic regimen, but patients may not have received radiation to the index lesion
    within 1 year of enrollment.

    Detailed Description

    Patients will be treated with subcutaneous injections of GAA/TT-vaccines starting on Week 0
    and every 3 weeks thereafter for up to 8 cycles or until Off-treatment criteria are met
    (Section 4.6). I.m. poly-ICLC will be administered (30ug/kg i.m.) immediately following the
    vaccine. Poly-ICLC should be administered i.m. within 3 cm of the peptide-injection site.

    To allow for flexibility with scheduling, the peptide vaccine and Poly-ICLC dose may be
    given within one week of the date that the vaccine and poly-ICLC administration are due.

    Patients will be evaluated for any possible adverse event, regimen limiting toxicity (RLT)
    as well as clinical/radiological responses by clinical visits and MRI scanning. Follow-up
    MRIs will be performed (Weeks 6, 15 and 24).

    Trial Arms

    Name Type Description Interventions
    HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC Experimental All subjects will receive vaccine plus Poly-ICLC. Injections will be given every 3 week for a total of 8 vaccines.

    Eligibility Criteria

    Inclusion Criteria:

    Tumor Type

    - Unresectable low-grade gliomas that have received at least two chemotherapy/biologic
    regimens. Radiation therapy counts as a biologic regimen. Patients may not have
    received radiation therapy to the index lesion within 1 year of enrollment. Patients
    may have tumor spread within the CNS.

    - HLA-A2 positive based on flow cytometry.

    - 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.

    - Patients must be 12 months and < 22 years of age at the time of HLA-A2 screening.

    - Patients must have a performance status of 70; (Karnofsky if > 16 years and Lansky
    if 16 years of age.

    - Documented negative serum beta-HCG for female patients who are post-menarchal.
    Because the effect of the peptide-based vaccine and poly-ICLC on the fetus has not
    sufficiently been investigated, pregnant females will not be included in the study.

    - Patients must be free of systemic infection requiring IV antibiotics at the time of
    registration. Patients must be off IV antibiotics for at least 7 days prior to
    registration.

    - Patients with adequate organ function as measured by: Bone marrow: ANC > 1,000/;
    Platelets > 100,000/ (transfusion independent); absolute lymphocyte count of
    500/; 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 must have recovered from the toxic effects of prior therapy to grade 1 or
    better. Patients must be at least 3 weeks from 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 may not have received radiation to the index lesion within 1 year of
    enrollment.

    - 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
    requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with
    visceral involvement.

    - Use of immunosuppressives within four weeks prior to study entry or anticipated use
    of immunosuppressive agents. Dexamethasone, or other corticosteroid medications, if
    used in the peri-operative period must be tapered to 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.

    - Because patients with immune deficiency are not expected to respond to this therapy,
    HIV-positive patients are excluded from the study.

    - Patients who have received prior immunotherapy.

    Minimum Eligible Age: 12 Months

    Maximum Eligible Age: 21 Years

    Eligible Gender: Both

    Primary Outcome Measures

    Tumor shrinkage or stable disease

    Secondary Outcome Measures

    Trial Keywords