What side effects are associated with this type of intervention?

Common side effects of immune stimulation therapies for neuroblastoma, such as those involving IL-2 and lymphotactin, include flu-like symptoms (fever, chills, fatigue), gastrointestinal issues (nausea, vomiting, diarrhea), and injection site reactions. More severe side effects can involve immune-related adverse events like organ inflammation (colitis, hepatitis) and, rarely, severe allergic reactions or autoimmune conditions. The investigational combination of SKNLP and SJNB-JF-IL2/Lptn vaccines may present additional specific side effects due to the genetic modifications and combined cytokine secretion.

What prior FDA approvals exist?

The FDA has approved several treatments for Neuroblastoma, but specific approvals for therapies involving immune stimulation via IL-2 and lymphotactin secretion are not well-documented. Generally, immunotherapy approaches for Neuroblastoma include the use of monoclonal antibodies like dinutuximab, which targets the GD2 antigen on neuroblastoma cells, and cytokine-based therapies that enhance the immune response. The combination of SKNLP and SJNB-JF-IL2/Lptn vaccines represents an innovative approach, focusing on genetically modified tumor cells to secrete IL-2 and lymphotactin, aiming to boost the patient's immune system to fight the cancer.

What other types of research exist?

Promising novel alternatives for neuroblastoma treatment in 2024 include: 1) Anti-GD2 monoclonal antibodies (e.g., dinutuximab) combined with cytokines and chemotherapy, which have shown improved survival rates. 2) CAR T-cell therapy targeting GD2, which is being actively researched and has shown potential in early trials. 3) ALK inhibitors (e.g., crizotinib) for patients with ALK mutations, offering a targeted approach. 4) Immune checkpoint inhibitors (e.g., nivolumab, pembrolizumab) being explored for their potential to enhance anti-tumor immunity. 5) Oncolytic virotherapy, using genetically modified viruses to selectively infect and kill cancer cells while stimulating an immune response.

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Cancer Vaccine

Combination Vaccine for Neuroblastoma (CHESAT Trial)

Q: What is the mechanism of action of this treatment?

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.

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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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.

Awards & 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: 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

0 / 7Eligibility criteria met

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.