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Cancer Vaccine

Combination Vaccine for Neuroblastoma (CHESAT Trial)

Phase 1 & 2
Waitlist Available
Led By Andras A. Heczey, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age <21 years at time of diagnosis
Histological proof of high-risk neuroblastoma at diagnosis
Must not have
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Patients must not be currently receiving any investigational agents or have received any tumor vaccines within the previous six months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include reactions related to immune response due to the vaccine components (IL-2/Lptn), such as inflammation at injection site, fever, fatigue, allergic reactions, and possibly autoimmune-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was diagnosed before turning 21.
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My diagnosis was high-risk neuroblastoma.
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I am preparing for a stem cell transplant after intensive chemotherapy.
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I meet all requirements for high dose chemotherapy with stem cell support.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
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I am not currently on experimental drugs or had cancer vaccines in the last 6 months.
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I am HIV-positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate the safety of repeated immunization with gene-modified, IL-2/lymphotactin secreting SJNB-JF-IL2 and SJNB-JF-Lptn cells co-administered with the unmodified SKNLP neuroblastoma cell line.
Secondary study objectives
Evaluate the immune response to these immunizations.

Side effects data

From 2019 Phase 2 trial • 10 Patients • NCT03007238
30%
Anemia
20%
Hypophosphatemia
20%
Dyspnea
20%
Sepsis
20%
Hyperglycemia
20%
Hypertension
10%
Atrial flutter
10%
Headache
10%
Bronchial infection
10%
Anal pain
10%
Nausea
10%
Anorexia
10%
Hyponatremia
10%
Adult respiratory distress syndrome
10%
Pneumonitis
10%
Catheter related infection
10%
Oral pain
10%
Non-cardiac chest pain
10%
Vascular access complication
10%
Alanine aminotransferase increased
10%
CD4 lymphocytes decreased
10%
Lymphocyte count decreased
10%
Platelet count decreased
10%
Hypokalemia
10%
Hypercalcemia
10%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose Level 2Experimental Treatment1 Intervention
SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 2 SKNLP
Group II: Dose Level 1Experimental Treatment1 Intervention
SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 1 SKNLP

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
Common treatments for Neuroblastoma often involve immunotherapy strategies that aim to enhance the body's immune response against cancer cells. The trial involving SKNLP and SJNB-JF-IL2/Lptn vaccines uses genetically modified neuroblastoma cells to secrete IL-2 and lymphotactin. IL-2 stimulates the growth and activity of T cells, which are crucial for attacking tumor cells, while lymphotactin attracts immune cells to the tumor site, improving the immune system's ability to target and destroy cancer cells. This approach is significant for Neuroblastoma patients as it offers a targeted, potentially less toxic alternative to conventional treatments like chemotherapy, by harnessing the body's own immune system to fight the cancer.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,018 Previous Clinical Trials
6,031,422 Total Patients Enrolled
13 Trials studying Neuroblastoma
298 Patients Enrolled for Neuroblastoma
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
111 Previous Clinical Trials
2,816 Total Patients Enrolled
11 Trials studying Neuroblastoma
256 Patients Enrolled for Neuroblastoma
Andras A. Heczey, MDPrincipal InvestigatorBaylor College of Medicine
2 Previous Clinical Trials
22 Total Patients Enrolled
2 Trials studying Neuroblastoma
22 Patients Enrolled for Neuroblastoma

Media Library

SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 1 SKNLP (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT00703222 — Phase 1 & 2
Neuroblastoma Research Study Groups: Dose Level 1, Dose Level 2
Neuroblastoma Clinical Trial 2023: SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 1 SKNLP Highlights & Side Effects. Trial Name: NCT00703222 — Phase 1 & 2
SNJB-JF-IL2 and SJNB-JF-Lptn + Dose Level 1 SKNLP (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00703222 — Phase 1 & 2
~0 spots leftby Sep 2025
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