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Anti-metabolites

Tumor Cell Vaccine + Cytoxan for Neuroblastoma (ATOMIC 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
Histologically proven high risk neuroblastoma in first or subsequent relapse or with primary refractory disease or inability to complete standard therapy
Age less than 21 at time of initial diagnosis
Must not have
Severe intercurrent infection or uncontrolled condition 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing an experimental treatment for neuroblastoma, which is a solid tumor that is the second most common cancer in children. The treatment consists of a series of immunizations using a tumor vaccine, combined with low-dose chemotherapy taken by mouth on a daily basis. The hope is that the vaccine will cause the immune system to recognize and kill more types of neuroblastoma tumors. Additionally, the immunizations will be combined with daily low dose chemotherapy.

Who is the study for?
This trial is for children under 21 with high-risk neuroblastoma that's relapsed or didn't respond to treatment. They must have a certain level of physical function, blood counts, liver and kidney function, not be pregnant or breastfeeding, and able to follow the study plan. Those who've had certain recent treatments or have severe infections, heart issues, HIV, or psychiatric conditions can't join.
What is being tested?
The trial tests a new approach combining a neuroblastoma vaccine (with unmodified SKNLP cells and gene-modified SJNB-JF-IL2/SJNB-JF-LTN cells) with daily low-dose oral Cytoxan chemotherapy. The goal is to boost the immune system's ability to fight cancer by reducing tumor-protecting cells and attacking tumor blood vessels.
What are the potential side effects?
Potential side effects include immune reactions from the vaccine leading to inflammation in various organs. Low-dose Cytoxan may cause nausea, hair loss, mouth sores, lowered immunity increasing infection risk; however specific side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My neuroblastoma is high risk and has either come back, didn't respond to treatment, or I couldn't complete standard therapy.
Select...
I was diagnosed before turning 21.
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My kidney function is within the required range.
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I am not pregnant and will use effective birth control during the study.
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I am able to live with some level of independence.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any severe infections or uncontrolled conditions that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Secondary study objectives
Number of Participants with Disease Progression as a Measure of Efficacy
Participants with T-cell changes as a Measure of Immune Response
Other study objectives
Analysis of Immunologic Measurements

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment PlanExperimental Treatment2 Interventions
Neuroblastoma Vaccine (unmodified SKNLP, with gene-modified SJNB-JF-IL2 and SJNB-JF-LTN neuroblastoma cells) and Cytoxan (Cyclophosphamide)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytoxan
2007
Completed Phase 3
~1460

Find a Location

Who is running the clinical trial?

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
112 Previous Clinical Trials
2,844 Total Patients Enrolled
11 Trials studying Neuroblastoma
270 Patients Enrolled for Neuroblastoma
Baylor College of MedicineLead Sponsor
1,024 Previous Clinical Trials
6,029,499 Total Patients Enrolled
13 Trials studying Neuroblastoma
312 Patients Enrolled for Neuroblastoma
Andras A. Heczey, MDPrincipal InvestigatorBaylor College of Medicine
2 Previous Clinical Trials
18 Total Patients Enrolled
2 Trials studying Neuroblastoma
18 Patients Enrolled for Neuroblastoma

Media Library

Cytoxan (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT01192555 — Phase 1 & 2
Neuroblastoma Research Study Groups: Treatment Plan
Neuroblastoma Clinical Trial 2023: Cytoxan Highlights & Side Effects. Trial Name: NCT01192555 — Phase 1 & 2
Cytoxan (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01192555 — Phase 1 & 2
~1 spots leftby Nov 2025
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