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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01130077
Recruitment Status : Recruiting
First Posted : May 25, 2010
Last Update Posted : December 24, 2019
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

Tracking Information
First Submitted Date  ICMJE May 24, 2010
First Posted Date  ICMJE May 25, 2010
Last Update Posted Date December 24, 2019
Study Start Date  ICMJE February 2009
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2015)
Safety [ Time Frame: 6 weeks ]
Tolerability during the first two vaccine courses as defined in the protocol.
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2010)
To determine the response rate and magnitude of immune response in post-vaccine peripheral blood mononuclear cells (PBMC) against the GAA peptides in response to the vaccine.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2015)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2010)
To assess the incidence and severity of adverse events associated with the vaccine.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study of Glioma Associated Antigen Vaccines in Conjunction With Poly-ICLC in Pediatric Gliomas
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Newly Diagnosed Pediatric Pontine Glioma
  • Newly Diagnosed Pediatric High Grade Glioma
  • Recurrent Pediatric High Grade Glioma
  • Recurrent Pediatric Low Grade Glioma
Intervention  ICMJE
  • Biological: HLA-A2 restricted glioma antigen peptides vaccine
    Vaccine given every 3 weeks
    Other Name: BB13624
  • Biological: Poly-ICLC
    Vaccine given every 3 weeks
Study Arms  ICMJE 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)
Interventions:
  • Biological: HLA-A2 restricted glioma antigen peptides vaccine
  • Biological: Poly-ICLC
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 24, 2010)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

**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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alberto Broniscer, MD 412 692-5055
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01130077
Other Study ID Numbers  ICMJE PRO08030085
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ian F. Pollack, M.D., University of Pittsburgh
Study Sponsor  ICMJE Ian F. Pollack, M.D.
Collaborators  ICMJE
  • Ellie Kavalieros Fund
  • Translational Brain Tumor Research Fund
  • Connor's Cure
Investigators  ICMJE
Principal Investigator: Alberto Broniscer, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP