Tumor Cell Vaccine + Cytoxan for Neuroblastoma
(ATOMIC Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAndras 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?Neuroblastoma is the second most common solid tumor seen in children, but causes approximately 15% of childhood cancer deaths each year. Patients with high-risk disease require treatment with a combination of chemotherapy, surgery, radiation, and stem cell transplant; however, many will have their disease come back within 3 years. Due to this high rate of relapse, this study is being done to investigate an experimental treatment option for children whose disease has returned. This clinical trial is for patients with neuroblastoma that has either come back after treatment or never went away in the first place. A series of immunizations will be administered using a tumor vaccine and add low-dose chemotherapy to be 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. Daily low-dose chemotherapy, also know as metronomic chemotherapy, works by attacking the blood vessels that allow tumors to grow. Using metronomic doses of a drug called cytoxan can also decrease T regulatory cells, a specific type of cell that tumors use to hide from the immune system. The purpose of this study is to test the safety and anti-tumor effect of the tumor cell vaccination plus low dose, metronomic chemotherapy in treating patients with relapsed/refractory neuroblastoma.

Eligibility Criteria

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.

Inclusion Criteria

I am able to live with some level of independence.

My neuroblastoma is high risk and has either come back, didn't respond to treatment, or I couldn't complete standard therapy.

I was diagnosed before turning 21.

+10 more

Exclusion Criteria

I am HIV positive.

Due to the unknown effects of this therapy on a fetus, pregnant women will be excluded from this research

Women who are breast-feeding

+4 more

Participant Groups

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.

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)

Cytoxan is already approved in European Union, United States, Canada, Japan, Australia for the following indications:

🇪🇺 Approved in European Union as Cyclophosphamide for: