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Immunotherapy for Recurrent Ependymomas in Children Using Tumor Antigen Peptides With Imiquimod

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: NCT01795313
Recruitment Status : Recruiting
First Posted : February 20, 2013
Last Update Posted : August 5, 2021
Sponsor:
Collaborators:
Solving Kids' Cancer
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ian F. Pollack, M.D., University of Pittsburgh

Brief Summary:
The purpose of this study is to see if vaccination with HLA-A2 restricted peptides, combined with the immunoadjuvant imiquimod is safe and can induce immune responses in children with recurrent ependymomas. Eligible patients are stratified by primary tumor location.

Condition or disease Intervention/treatment Phase
Ependymoma Biological: HLA-A2 restricted synthetic tumor antigen Drug: Imiquimod Other: enzyme-linked immunosorbent assay Other: flow cytometry Other: immunohistochemistry staining method Other: laboratory biomarker analysis Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a pilot study to assess tolerability of our vaccine regimen in children with ependymomas initially arising above or below the tentorium
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immunotherapy for Recurrent Ependymomas in Children Using Human Leukocyte Antigen (HLA)-A2 Restricted Tumor Antigen Peptides in Combination With Imiquimod
Study Start Date : August 2012
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines
Drug Information available for: Imiquimod

Arm Intervention/treatment
Experimental: HLA-A2 restricted tumor antigen vaccine
This is a single-arm study of a HLA-A2 restricted tumor antigen peptide vaccine, administered in conjunction with imiquimod
Biological: HLA-A2 restricted synthetic tumor antigen
Drug: Imiquimod
Other: enzyme-linked immunosorbent assay
Other: flow cytometry
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis



Primary Outcome Measures :
  1. Number of Participants with unacceptable toxicity [ Time Frame: 2 years ]
    Grade 3 or 4 non-hematological toxicities.


Secondary Outcome Measures :
  1. Tumor-associated antigen-specific T-cell [ Time Frame: 2 years ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Months to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: All grades of ependymoma are eligible.

  • Patients must have recurrent/progressive ependymoma that has progressed or recurred after initial adjuvant therapy.
  • HLA-A2 positive based on flow cytometry performed at the University of Pittsburgh.
  • Patients must have previously received standard initial therapy including attempted gross total resection, where safely feasible, and in appropriate circumstances (e.g., those older than one year at initial diagnosis, with non-metastatic tumors and at least microscopic residual disease), involved field fractionated radiation therapy (RT). Patients may have received re-irradiation but not to the index lesion within 4 weeks.
  • 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 study registration.
  • Patients must have a performance status of ≥ 70; (Karnofsky if > 16 years and Lansky if ≤ 16 years of age).
  • Patients may have non-bulky, asymptomatic metastatic disease.
  • 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).
  • Patients must be free of systemic infection requiring IV antibiotics at the time of registration and off IV antibiotics for at least 7 days prior to registration.
  • Patients must have adequate organ function as measured by:

    • Bone marrow: Absolute neutrophil count (ANC) > 1,000/µl; Platelets > 100,000/µl (transfusion independent); Absolute lymphocyte count (ALC) ≥ 500/µl; Hemoglobin >8 g/dl (may be transfused).
    • Hepatic: bilirubin ≤ 1.5x institutional normal for age; serum glutamate pyruvate transaminase (SGPT) < 3x institutional normal
    • Renal: Serum creatinine based on age or creatinine clearance or radioisotope glomerular filtration rate (GFR) > 70 ml/min/1.73 m²
  • Patients must have recovered from the toxic effects of prior therapy and be at least 3 weeks from the last dose of standard cytotoxic chemotherapy or myelosuppressive biological therapy, at least one week from the last dose of non-myelosuppressive biological therapy and at least 4 weeks from the completion of radiation therapy.
  • Patients must have no overt cardiac, gastrointestinal, pulmonary, or psychiatric disease.

Patients must be willing to travel to Pittsburgh to receive the vaccine. Visits: Every 3 weeks x 9, then every 6 weeks x 12 depending on response/side effects

Exclusion Criteria:

  • Patients living outside of North America are not eligible.
  • Patients must be off concurrent treatment or medications 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®), and any investigational therapeutic medication.
  • Patients must not have a history of any immune system disorder or laboratory abnormality or any condition that could potentially alter immune function.
  • Use of immunosuppressives within four weeks prior to study entry or anticipated use of immunosuppressive agents. Patients must be on 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 a known immune deficiency.
  • Pregnancy or breastfeeding. Female patients who are post-menarchal must have a documented negative pregnancy test.
  • Tetanus vaccine during therapy or within 1 week prior to enrollment.
  • Patients who have received prior immunotherapy.

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): NCT01795313


Contacts
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Contact: Alberto Broniscer, MD 412-692-5055

Locations
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United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Sharon Dibridge    412-692-7070    sharon.dibridge@chp.edu   
Sponsors and Collaborators
Ian F. Pollack, M.D.
Solving Kids' Cancer
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Alberto Broniscer, MD University of Pittsburgh
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Responsible Party: Ian F. Pollack, M.D., Professor of Neurosurgery, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01795313    
Other Study ID Numbers: STUDY19100001
R01CA174858 ( U.S. NIH Grant/Contract )
PRO12050422 ( Other Identifier: Former IRB protocol ID )
First Posted: February 20, 2013    Key Record Dates
Last Update Posted: August 5, 2021
Last Verified: August 2021
Additional relevant MeSH terms:
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Ependymoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers