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Cancer Vaccine
Vaccine Immunotherapy for Pediatric Brain Cancer (Re-MATCH Trial)
Phase 2
Waitlist Available
Led By Duane Mitchell, MD, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline compared to 6 weeks post vaccine #1 and longitudinal measures through overall survival (up to 60 months)
Awards & highlights
No Placebo-Only Group
Summary
This trial uses special immune cells and vaccines made from the patient's tumor to treat children with recurring brain tumors. The goal is to help their immune system recognize and destroy cancer cells, offering a new option for those who do not respond well to traditional treatments.
Who is the study for?
This trial is for children and young adults up to 30 years old with a first recurrence of medulloblastoma or primitive neuroectodermal tumors after radiotherapy. Participants need stable neurological function, adequate blood counts, normal kidney and liver function, and must agree to use birth control. Those with genetic risks for radiation-induced cancers are also eligible.
What is being tested?
The study tests tumor-specific immune cells (TTRNA-xALT) and dendritic cell vaccines (TTRNA-DCs) on about 35 patients with recurrent brain tumors. It aims to see how these immunotherapies affect the tumor's progression based on prior success in adult cancer treatments.
What are the potential side effects?
While specific side effects aren't listed here, immunotherapy can generally cause flu-like symptoms, fatigue, rash, fever, chills, weakness or dizziness. More serious reactions might include changes in blood pressure or heart rate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline compared to 6 weeks post vaccine #1 and longitudinal measures through overall survival (up to 60 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline compared to 6 weeks post vaccine #1 and longitudinal measures through overall survival (up to 60 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
12 Month Progression-free Survival (PFS-12)
Secondary study objectives
Characterize Immunologic Phenotype of Lymphocyte Subsets and NK Cells
Correlate Magnitude and Persistence of Anti-tumor Humoral or Cellular Immunity With Clinical Outcome
Determine of Overall Survival Rate
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group BExperimental Treatment2 Interventions
NMA Salvage chemotherapy plus peripheral blood stem cell transplant followed by TTRNA-xALT and TTRNA-DCs.
Group II: Group AExperimental Treatment2 Interventions
High dose chemotherapy plus peripheral blood stem cell transplant followed by TTRNA-xALT and TTRNA-DCs.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Neuroectodermal Tumors, such as tumor-specific immune cells and dendritic cell vaccines, work by directly targeting cancer cells and enhancing the body's immune response. Tumor-specific immune cells, like CAR T-cells, are engineered to recognize and attack cancer cells, thereby reducing tumor size.
Dendritic cell vaccines, on the other hand, stimulate the patient's immune system by presenting tumor antigens to T-cells, which then mount a targeted attack against the tumor. These mechanisms are crucial for Neuroectodermal Tumor patients as they offer a more precise and potentially less toxic alternative to traditional therapies, improving the chances of effective treatment and reducing side effects.
Once, Twice, Three Times a Finding: Reproducibility of Dendritic Cell Vaccine Trials Targeting Cytomegalovirus in Glioblastoma.Immunotherapy for Medulloblastoma: Current Perspectives.New anticancer immunotherapies.
Once, Twice, Three Times a Finding: Reproducibility of Dendritic Cell Vaccine Trials Targeting Cytomegalovirus in Glioblastoma.Immunotherapy for Medulloblastoma: Current Perspectives.New anticancer immunotherapies.
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,404 Previous Clinical Trials
766,304 Total Patients Enrolled
United States Department of DefenseFED
913 Previous Clinical Trials
334,280 Total Patients Enrolled
Duane Mitchell, MD, PhDPrincipal InvestigatorUniversity of Florida
5 Previous Clinical Trials
225 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have HIV, Hepatitis B or C, or any known immunosuppressive disease.I am 30 years old or younger.I am taking medication that weakens my immune system for another health issue.My neurological symptoms have been stable for at least a week.My brain tumor is suspected to have returned or worsened after initial radiation treatment.I need targeted radiation for my recurring brain tumor.I have an active kidney, heart, or lung disease.I have an infection needing treatment or a fever over 101.5F without a known cause.My cancer has returned, and I can't have radiation due to a genetic risk of more cancer.I or my guardian agree to a stem cell or bone marrow collection if needed.I can attend all required follow-up visits and tests for therapy side effects.My cancer has returned after initial radiation treatment.I can do most activities but may need assistance.
Research Study Groups:
This trial has the following groups:- Group 1: Group A
- Group 2: Group B
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.