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Immunotherapy for Ependymoma
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2014 Phase 3 trial • 467 Patients • NCT02120898Trial Design
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- I have received a tetanus vaccine recently or will receive it during my treatment.I have been stable and on low-dose or no corticosteroids for at least a week.I am mostly active and can care for myself.I haven't taken any medications or treatments for at least a week.I have previously received immunotherapy.My diagnosis is ependymoma, regardless of its grade.My ependymoma cancer has returned or worsened after initial treatment.My HLA-A2 test result is positive.I haven't used immunosuppressives in the last 4 weeks and don't plan to use them.My cancer has spread but isn't causing symptoms and isn't large.I agree to use effective birth control during the study.My organs are functioning well.I have recovered from previous cancer treatments and it's been over 3 weeks since my last dose.I am willing to travel to Pittsburgh for vaccine treatments as scheduled.I've had surgery, radiation, and possibly re-radiation (not in the last 4 weeks) for my cancer.I am between 12 months and 22 years old.I do not have any immune system disorders or conditions that could affect my immune function.I do not have any serious heart, stomach, lung, or mental health issues.I am not currently on IV antibiotics for an infection.
- Group 1: HLA-A2 restricted tumor antigen vaccine
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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"
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."
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."
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."
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."
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."
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