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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Children's Hospital of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Stratum A,B and E NCI R21 CA149872
Stratum C-Brain Tumor Society
Stratum D- P01NS40923
Information provided by (Responsible Party):
Regina Jakacki, Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01130077
First received: May 24, 2010
Last updated: August 7, 2012
Last verified: August 2012
  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 synthetic glioma antigen peptides vaccine
Drug: Poly ICLC
Genetic: Reverse transcriptase-polymerase chain reaction
Other: enzyme-linked immunosorbent assay
Other: flow cytometry
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate the Effects of Vaccinations With HLA-A2-Restricted Glioma Antigen-Peptides in Combination With Poly-ICLC for Children With Newly Diagnosed Malignant or Intrinsic Brain Stem Gliomas (BSG) or Non-Brainstem High-Grade Gliomas (HGG) or Recurrent Unresectable Low-Grade Gliomas (LGG) or Recurrent High Grade Gliomas

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Pittsburgh:

Primary Outcome Measures:
  • Safety [ Designated as safety issue: Yes ]
    The incidence and severity of adverse events associated with the vaccine regimen


Secondary Outcome Measures:
  • Glioma-associated antigen-specific T-cell response [ 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 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Months to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Eligibility 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. Patients must be registered within 4-12 weeks of completing radiation.

Stratum B: Newly diagnosed, non-brainstem high-grade glioma* Patients may not have received chemotherapy during or after radiation. Patients must be registered within 4-12 weeks of completing 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.

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. Patients must be registered within 4-12 weeks of completing radiation.

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. Patients must be registered within 4-12 weeks of completing radiation.

  • 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; (Karnofsky if > 16 years and Lansky if ≤ 16 years of age.
  • Patients must have life expectancy of at least 8 weeks.
  • documented negative serum βHCG 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. Males and females must agree to use effective birth control methods during the course of vaccination (from the first vaccine to two weeks after the last vaccine). Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the peptide-based vaccine and poly-ICLC, breastfeeding should be discontinued if the mother is treated in this study.
  • Patients must be free of systemic infection at the time of registration. Patients on IV antibiotic therapy 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/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. Any questions related to the definition of non-cytotoxic agents should be directed to the Principal Investigator.
  • No overt cardiac, gastrointestinal, pulmonary or psychiatric disease.

    • Exclusion Criteria

3.2.1 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.

3.2.2 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 (see 3.1.3) 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.

3.2.3 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

3.2.4 Patients must not have a history of, or currently active autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement.

3.2.5 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 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.

3.2.6 Patients with known addiction to alcohol or illicit drugs.

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

3.3 Start of Treatment

3.3.1 Patients must be registered prior to the start of treatment.

3.3.2 The date protocol therapy is projected to start must be no later than 7 days after the date of study registration.

  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

Locations
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Angela Krol, BSN    412-692-8047    angela.krol@chp.edu   
Sponsors and Collaborators
Children's Hospital of Pittsburgh
Stratum A,B and E NCI R21 CA149872
Stratum C-Brain Tumor Society
Stratum D- P01NS40923
Investigators
Principal Investigator: Regina Jakacki, MD Children's Hospital of Pittsburgh of UPMC
  More Information

No publications provided by Children's Hospital of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Regina Jakacki, MD, Professor of Pediatrics Director, Pediatric Neuro-Oncology Program, Children's Hospital 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: August 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital of Pittsburgh:
Pediatric glioma
Vaccine therapy

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

ClinicalTrials.gov processed this record on August 20, 2014