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Cancer Vaccine

Immunotherapy for Ependymoma

Phase 1
Recruiting
Led By Alberto Broniscer, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with unacceptable toxicity
Secondary outcome measures
Tumor-associated antigen-specific T-cell

Side effects data

From 2014 Phase 3 trial • 467 Patients • NCT02120898
2%
Nasopharyngitis
2%
Sinusitis
2%
Squamous cell carcinoma of skin
1%
Upper respiratory tract infection
1%
Hip fracture
1%
Orthostatic hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vehicle Cream
Generic Imiquimod Cream 2.5%
Zyclara® (Imiquimod) Cream 2.5%

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total enrollment number for this research endeavor?

"Affirmative, the details published on clinicaltrials.gov indicate that this research project is actively recruiting participants. This study was first advertised on August 1st 2012 and most recently amended on October 23rd 2022; 24 patients need to be recruited from a single location."

Answered by AI

Who is eligible to take part in this medical experiment?

"This clinical trial is searching for 24 participants aged between 12 months and 21 years with a diagnosis of ependymoma. In order to be eligible, patients must have received prior standard treatment, including attempted gross total resection followed by fractionated radiation therapy (RT). Additionally, they should not currently suffer from systemic infection or active IV antibiotic therapy; low-dose corticosteroid usage within the past week is also acceptable. Furthermore, their performance status needs to exceed 70 on either Karnofsky or Lansky scales depending on age. Lastly, all candidates need to possess HLA-A2 positive results based on flow cytometry performed at"

Answered by AI

Is this medical research accepting new participants?

"Affirmative. The information published on clinicaltrials.gov suggests that this medical investigation, which was initially announced in August 2012, is presently recruiting participants. A total of 24 people are expected to be recruited from a single site."

Answered by AI

Does the protocol encompass individuals aged 85 and above?

"Patients who are younger than 21 years old and have attained at least one year of age can be enrolled in this trial."

Answered by AI

In what clinical situations is Imiquimod commonly prescribed?

"Imiquimod is frequently employed to treat scalp structure, as well as conditions such as condylomata acuminata, facial skin lesions and superficial basal cell carcinoma."

Answered by AI

What other explorations have been conducted surrounding the use of Imiquimod?

"Presently, there are 21 active studies involving Imiquimod with 5 of the trials at Phase 3. Most of these research sites are located in Houston, Texas but 84 other locations around the world have launched their own clinical investigations using this drug."

Answered by AI

Is there a potential risk of harm when using Imiquimod?

"Imiquimod's safety has been established to a limited degree, leading it to receive an assessment score of 1."

Answered by AI
~1 spots leftby Dec 2024