Combination Vaccine for Neuroblastoma

(CHESAT Trial)

Overseen by Andras A. Heczey, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Baylor College of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new treatment for high-risk neuroblastoma using two types of cancer cell vaccines. One vaccine is modified to release proteins that boost the immune system. The goal is to help the body fight cancer more effectively.

Research Team

Andras A. Heczey, MD

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

This trial is for individuals under 21 years old with high-risk neuroblastoma, who are about to have stem cell rescue after intense chemotherapy. They must not be pregnant, HIV positive, or have received other vaccines or investigational agents in the past six months. Participants should agree to effective birth control during and for six months post-trial.

Inclusion Criteria

HIV negative

I was diagnosed before turning 21.

My diagnosis was high-risk neuroblastoma.

Exclusion Criteria

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

I am not currently on experimental drugs or had cancer vaccines in the last 6 months.

Pregnant

Treatment Details

Interventions

• SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 1 SKNLP (Cancer Vaccine)
• SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 2 SKNLP (Cancer Vaccine)

Trial Overview The study tests the safety and effectiveness of two allogeneic neuroblastoma tumor cell line vaccines combined with IL-2/Lptn secretion on patients with high-risk neuroblastoma undergoing chemotherapy and autologous stem cell rescue as consolidation therapy.

Participant Groups

Group I: Dose Level 2 Experimental Treatment 1 Intervention

SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 2 SKNLP

Group II: Dose Level 1 Experimental Treatment 1 Intervention

SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 1 SKNLP

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Center for Cell and Gene Therapy, Baylor College of Medicine

Collaborator

Trials

114

Recruited

2,900+