RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Immunotherapy for Recurrent Ependymomas in Children Using Human Leukocyte Antigen (HLA)-A2 Restricted Tumor Antigen Peptides in Combination with Imiquimod

Quick Facts

Study Start:2012-08

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01795313

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Months to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* 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 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.

Inclusion Criteria

Exclusion Criteria

* 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 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.

Contacts and Locations

Study Contact

James Felker, MD

CONTACT

412-692-5055

Sharon Dibridge

CONTACT

412-692-7070

sharon.dibridge@chp.edu

Principal Investigator

James Felker, MD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224

United States

Collaborators and Investigators

Sponsor: James Felker

James Felker, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2012-08

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2012-08

Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

Ependymoma