Vaccine Immunotherapy for Pediatric Brain Cancer

(Re-MATCH Trial)

Recruiting at 2 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Florida

Must not be taking: Immunosuppressants, Anticancer drugs

Disqualifiers: Pregnancy, Active infection, Immunosuppressive disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

26 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Duane Mitchell, MD, PhD

Principal Investigator

University of Florida

Eligibility Criteria

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.

Inclusion Criteria

I am 30 years old or younger.

Signed informed consent according to institutional guidelines must be obtained prior to registration

My neurological symptoms have been stable for at least a week.

Exclusion Criteria

I do not have HIV, Hepatitis B or C, or any known immunosuppressive disease.

Patients receiving any other concurrent anticancer or investigational drug therapy

I am taking medication that weakens my immune system for another health issue.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Resection/Biopsy

Surgical resection, biopsy, or cytology examination with confirmatory pathologic diagnosis

1-2 weeks

Chemotherapy and Stem Cell Transplantation

High dose or non-myeloablative chemotherapy followed by peripheral blood stem cell transplant

4-6 weeks

Immunotherapy

Administration of TTRNA-xALT and TTRNA-loaded dendritic cell vaccines

6 weeks

Weekly visits for 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 60 months

Treatment Details

Interventions

• TTRNA-DCs
• TTRNA-xALT

Trial Overview 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.

Participant Groups

Group I: Group B Experimental Treatment 2 Interventions

NMA Salvage chemotherapy plus peripheral blood stem cell transplant followed by TTRNA-xALT and TTRNA-DCs.

Group II: Group A Experimental Treatment 2 Interventions

High dose chemotherapy plus peripheral blood stem cell transplant followed by TTRNA-xALT and TTRNA-DCs.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+