Clinical Trials /

Immunotherapy for Recurrent Ependymomas in Children Treatment for Recurrent Ependymomas Using HLA-A2 Restricted Tumor Antigen Peptides in Combination With Imiquimod

NCT01795313

Description:

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.

Related Conditions:
  • Ependymoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Immunotherapy for Recurrent Ependymomas in Children Treatment for Recurrent Ependymomas Using HLA-A2 Restricted Tumor Antigen Peptides in Combination With Imiquimod
  • Official Title: Immunotherapy for Recurrent Ependymomas in Children Treatment for Recurrent Ependymomas Using HLA-A2 Restricted Tumor Antigen Peptides in Combination With Imiquimod

Clinical Trial IDs

  • ORG STUDY ID: PRO12050422
  • SECONDARY ID: R01CA174858
  • NCT ID: NCT01795313

Conditions

  • Ependymoma

Interventions

DrugSynonymsArms
HLA-A2 restricted synthetic tumor antigenHLA-A2 restricted tumor antigen vaccine
ImiquimodHLA-A2 restricted tumor antigen vaccine

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
HLA-A2 restricted tumor antigen vaccineExperimentalThis is a single-arm study of a HLA-A2 restricted tumor antigen peptide vaccine, administered in conjunction with imiquimod
  • HLA-A2 restricted synthetic tumor antigen
  • Imiquimod

Eligibility 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: ANC > 1,000/µl; Platelets > 100,000/µl (transfusion independent);
                  ALC ≥ 500/µl; 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/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 injetions, growth
             factors (e.g. Pricrut®, 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.
      
Maximum Eligible Age:21 Years
Minimum Eligible Age:12 Months
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with unacceptable toxicity
Time Frame:2 years
Safety Issue:
Description:Grade 3 or 4 non-hematological toxicities.

Secondary Outcome Measures

Measure:Tumor-associated antigen-specific T-cell
Time Frame:2 years
Safety Issue:
Description:

Details

Phase:N/A
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Ian F. Pollack, M.D.

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