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Cancer Vaccine

Immunotherapy for Ependymoma

Phase 1
Recruiting
Led By James Felker, MD
Research Sponsored by James Felker
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have a performance status of ≥ 70
Patients must have recurrent/progressive ependymoma that has progressed or recurred after initial adjuvant therapy
Must not have
Use of immunosuppressives within four weeks prior to study entry or anticipated use of immunosuppressive agents
Patients who have received prior immunotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Approved for 5 Other Conditions
All Individual Drugs Already Approved

Summary

This trial is studying if a combination of a vaccine and a drug is safe and can help the immune system fight ependymoma in children.

Who is the study for?
This trial is for children with recurrent ependymoma, a type of brain tumor. Participants must be between 1 and 21 years old, HLA-A2 positive, have had prior standard therapy including surgery and radiation if appropriate, and be off high-dose steroids. They should not have immune deficiencies or be on immunosuppressive drugs.
What is being tested?
The study tests whether a vaccine made from specific tumor proteins combined with an immune-boosting cream (Imiquimod) can provoke an immune response safely in these patients. The treatment involves regular visits to Pittsburgh for vaccination over several months.
What are the potential side effects?
Potential side effects may include local skin reactions at the cream application site or where the vaccine is injected, flu-like symptoms such as fever or chills, fatigue, allergic reactions to components of the vaccine, and possible autoimmune responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am mostly active and can care for myself.
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My ependymoma cancer has returned or worsened after initial treatment.
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My HLA-A2 test result is positive.
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I am between 12 months and 22 years old.
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I have recovered from previous cancer treatments and it's been over 3 weeks since my last dose.
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I do not have any serious heart, stomach, lung, or mental health issues.
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I am not currently on IV antibiotics for an infection.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't used immunosuppressives in the last 4 weeks and don't plan to use them.
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I have previously received immunotherapy.
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I do not have any immune system disorders or conditions that could affect my immune function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants with unacceptable toxicity

Side effects data

From 2014 Phase 3 trial • 467 Patients • NCT02120898
3%
Upper respiratory tract infection
2%
Fatigue
2%
Diarrhoea
1%
Application site pain
1%
Squamous cell carcinoma of skin
1%
Presyncope
1%
Hypertensive crisis
1%
Depression
1%
Coronary artery disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Zyclara® (Imiquimod) Cream 2.5%
Vehicle Cream
Generic Imiquimod Cream 2.5%

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups
Experimental Treatment
Group I: HLA-A2 restricted tumor antigen vaccineExperimental Treatment6 Interventions
This is a single-arm study of a HLA-A2 restricted tumor antigen peptide vaccine, administered in conjunction with imiquimod
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imiquimod
FDA approved

Find a Location

Who is running the clinical trial?

James FelkerLead Sponsor
2 Previous Clinical Trials
85 Total Patients Enrolled
Ian F. Pollack, M.D.Lead Sponsor
4 Previous Clinical Trials
108 Total Patients Enrolled
Solving Kids' CancerOTHER
9 Previous Clinical Trials
109 Total Patients Enrolled
2 Trials studying Ependymoma
40 Patients Enrolled for Ependymoma

Media Library

HLA-A2 restricted synthetic tumor antigen (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT01795313 — Phase 1
Ependymoma Research Study Groups: HLA-A2 restricted tumor antigen vaccine
Ependymoma Clinical Trial 2023: HLA-A2 restricted synthetic tumor antigen Highlights & Side Effects. Trial Name: NCT01795313 — Phase 1
HLA-A2 restricted synthetic tumor antigen (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01795313 — Phase 1
~0 spots leftby Dec 2024
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