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A Vaccine Trial for Low Grade Gliomas

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ClinicalTrials.gov Identifier: NCT02358187
Recruitment Status : Recruiting
First Posted : February 6, 2015
Last Update Posted : January 17, 2018
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Low Grade Glioma Biological: Experimental: HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC Phase 2

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).

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : January 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC
All subjects will receive vaccine plus Poly-ICLC. Injections will be given every 3 week for a total of 8 vaccines.
Biological: Experimental: HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC
Poly-ICLC is administered intramuscularly (i.m.) using sterile technique, as supplied from the vial, and in the amount prescribed for the participant's weight. Patients should receive a dose of acetaminophen (15 mg/kg up to a max of 1000 mg) 30-60 minutes before each poly-ICLC administration. The poly-ICLC treatments will be administered immediately following the vaccine. Patients/parents will be asked to report any temperature elevations and side effects after each treatment.

Outcome Measures

Primary Outcome Measures :
  1. Tumor shrinkage or stable disease [ Time Frame: Week 24 ]
    Participants who demonstrate radiological evidence of tumor shrinkage or stable disease without regimen-limiting toxicity (RLT) after the initial 8 vaccines will be eligible to receive additional vaccinations beginning week 24 and every 6 weeks thereafter for up to two years.

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

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/µ; Platelets > 100,000/µ (transfusion independent); absolute lymphocyte count of ≥ 500/µ; 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 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 living outside of North America are not eligible.
  • 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.
Contacts and Locations

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): NCT02358187

Contact: Alberto Broniscer, MD 412 692-5055
Contact: Carole Rimer, RN 412 692-7336 carole.rimer@chp.edu

United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Carole Rimer, RN    412-692-7336    carole.rimer@chp.edu   
Sponsors and Collaborators
Ian F. Pollack, M.D.
Connor's Cure
National Cancer Institute (NCI)
Principal Investigator: Alberto Broniscer, MD Children's Hospital of Pittsburgh of UPMC
More Information

Responsible Party: Ian F. Pollack, M.D., Professor of Pediatrics, University of Pittsburgh, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02358187     History of Changes
Other Study ID Numbers: PRO13110086
R01CA187219 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Poly I-C
Carboxymethylcellulose Sodium
Immunologic Factors
Physiological Effects of Drugs
Interferon Inducers
Gastrointestinal Agents
Antiviral Agents
Anti-Infective Agents