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Cancer Vaccine
Neoantigen Vaccine for Advanced Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by Jaime Leandro Foundation for Therapeutic Cancer Vaccines
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial tests vaccines to treat advanced cancer in up to 20 people.
Who is the study for?
Adults with advanced solid tumors that have worsened after standard treatments, or when no effective standard treatment exists, or if they can't receive standard therapy. They should be in a condition where their survival chance is below 50% over the next five years and must not have severe allergies to vaccines or ingredients in the study vaccine.Check my eligibility
What is being tested?
The trial is testing personalized synthetic long peptide vaccines designed for each patient's unique tumor makeup. Up to 20 participants will receive these custom-made vaccines aimed at treating various advanced cancers.See study design
What are the potential side effects?
Potential side effects may include allergic reactions like anaphylaxis, hives, respiratory difficulties due to vaccine components, and possibly other immune-related responses given it's a new type of treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To assess the immune response to neoantigen synthetic long peptide vaccines as measured by percent of patients with ELISPOT positive response
To determine the safety of neoantigen synthetic peptide vaccines by rate of serious safety events by CTCAE v5.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Personalized Synthetic Long Peptide VaccineExperimental Treatment1 Intervention
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Who is running the clinical trial?
Jaime Leandro Foundation for Therapeutic Cancer VaccinesLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I will use birth control or abstain from sex during and for 3 months after the study.My advanced cancer has low survival odds and has not responded to standard treatments.I am a woman who can have children and agree to use 2 forms of birth control and abstain from sex, if needed, during the study.My doctor believes my organs are functioning well enough for treatment.I have an immune system disorder that prevents me from receiving vaccines.I am 18 years old or older.I am on a low dose of steroids, not more than 4 mg of dexamethasone or its equivalent.I can take care of myself but might not be able to do heavy physical work.I am a woman who cannot become pregnant because I am post-menopausal or have been surgically sterilized.I am not on long-term medications that could affect vaccine treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Personalized Synthetic Long Peptide Vaccine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What criteria must I fulfill to be eligible for this research program?
"Eligible candidates for this clinical trial must be between 12 and 110 years old, have a cancer diagnosis, and are expected to number around 20 individuals."
Answered by AI
Are new participants being onboarded for this experiment?
"This clinical trial is not currently recruiting, as reported on clinicialtrials.gov; it was initially posted on November 30th 2022 and last updated February 20th 2023. Despite this inactive status of this particular study, 3010 other medical trials are actively seeking candidates at the moment."
Answered by AI
Does this research accept participants over the age of forty?
"This clinical trial permits patients aged 12 to 110 to be enrolled, as stated in the enrollment criteria."
Answered by AI
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