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Alkylating Agent

Tolcapone and Oxaliplatin for Neuroblastoma

Phase 1
Waitlist Available
Research Sponsored by Giselle Sholler
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

The purpose of this research study is to evaluate an investigational drug (Tolcapone) alone and in combination with oxaliplatin, for relapsed and refractory neuroblastoma. Tolcapone is approved by the U.S. Food and Drug Administration (FDA) for adults, but is an investigational drug in this study because it has not been approved in pediatrics for this indication. Oxaliplatin, although a drug approved by the FDA for other cancers, is investigational for treatment of neuroblastoma in this study. This study will look at the safety and tolerability of tolcapone in combination with oxaliplatin as well as the tumors response to this study drug.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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
Determine the Overall Response Rate (ORR) of Participants using RECIST criteria
Determine the Progression Free Survival (PFS) of Participants using days until progression
To evaluate the drug levels and pharmacokinetics (PK) of Tolcapone from blood samples at multiple time points within the first 24 hours on study based on Area Under the Curve (AUC).
+4 more

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: Tolcapone and OxaliplatinExperimental Treatment2 Interventions
Subjects will receive oral tolcapone at their assigned dose level on each day of this 21-day cycle. Oxaliplatin will be given at 100 mg/m2 IV on Day 1 of Cycle 2 through 5 and any subsequent 21-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tolcapone
2014
Completed Phase 2
~630
Oxaliplatin
2011
Completed Phase 4
~2890

Find a Location

Who is running the clinical trial?

Giselle ShollerLead Sponsor
22 Previous Clinical Trials
2,485 Total Patients Enrolled
19 Trials studying Neuroblastoma
1,858 Patients Enrolled for Neuroblastoma
Giselle SaulnierShollerLead Sponsor
21 Previous Clinical Trials
2,400 Total Patients Enrolled
18 Trials studying Neuroblastoma
1,773 Patients Enrolled for Neuroblastoma
Wake Forest University Health SciencesLead Sponsor
1,352 Previous Clinical Trials
1,031,360 Total Patients Enrolled
19 Trials studying Neuroblastoma
1,830 Patients Enrolled for Neuroblastoma
~1 spots leftby Oct 2025
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