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Cancer Vaccine

Combination Vaccine for Neuroblastoma (CHESAT Trial)

Q: Does this research trial have any vacancies for participants?

<p>As discovered on clinicaltrials.gov, this specific trial is not currently enrolling patients. This study was initially posted in June 2008 and last edited in March 2022; however, there are 161 other studies actively accepting participants at the moment.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

CHESAT Trial Summary

This trial will test the safety of a new combination vaccine for patients with high risk neuroblastoma, as well as its ability to elicit an immune response and shrink tumors.

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.Check my eligibility

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.See study design

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.

CHESAT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I was diagnosed before turning 21.

Select...

My diagnosis was high-risk neuroblastoma.

Select...

I am preparing for a stem cell transplant after intensive chemotherapy.

Select...

I meet all requirements for high dose chemotherapy with stem cell support.

CHESAT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Evaluate the immune response to these immunizations.

Side effects data

From 2019 Phase 2 trial • 10 Patients • NCT03007238

30%

Anemia

20%

Sepsis

20%

Hypertension

20%

Hypophosphatemia

20%

Hyperglycemia

20%

Dyspnea

10%

Bronchial infection

10%

Pneumonitis

10%

Hypotension

10%

Catheter related infection

10%

Hypokalemia

10%

Headache

10%

Anal pain

10%

Anorexia

10%

Oral pain

10%

CD4 lymphocytes decreased

10%

Alanine aminotransferase increased

10%

Lymphocyte count decreased

10%

Nausea

10%

Non-cardiac chest pain

10%

Hypercalcemia

10%

Vascular access complication

10%

Adult respiratory distress syndrome

10%

Atrial flutter

10%

Platelet count decreased

10%

Hyponatremia

100%

80%

60%

40%

20%

Study treatment Arm

Overall Study

CHESAT 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,001,945 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

2,810 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research trial have any vacancies for participants?

"As discovered on clinicaltrials.gov, this specific trial is not currently enrolling patients. This study was initially posted in June 2008 and last edited in March 2022; however, there are 161 other studies actively accepting participants at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase I/II Study Of Immunization With Lymphotactin And Interleukin 2 Gene Modified Neuroblastoma Tumor Cells

Andras Heczey 2008. "A Phase I/II Study Of Immunization With Lymphotactin And Interleukin 2 Gene Modified Neuroblastoma Tumor Cells". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00703222.

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