Sorafenib + Cyclophosphamide/Topotecan for Neuroblastoma
(N2013-02 Trial)

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: New Approaches to Neuroblastoma Therapy Consortium

No Placebo Group

Trial Summary

What is the purpose of this trial?This study will combine three drugs: sorafenib, cyclophosphamide and topotecan. Adding sorafenib to cyclophosphamide and topotecan may increase the effectiveness of this combination. The investigators first need to find out the highest dose of sorafenib that can be given safely together with cyclophosphamide and topotecan. This is the first study to test giving these three drugs together and will help determine the highest dose of sorafenib that can safely be given together with cyclophosphamide and topotecan to patients with resistant/relapsed neuroblastoma.

Eligibility Criteria

This trial is for patients under 30 with high-risk neuroblastoma that's come back or didn't respond to treatment. They should have a certain level of bone marrow activity, no recent other cancer treatments, and be able to perform daily activities at least half the time. Not eligible if pregnant, breastfeeding, had an allogeneic transplant, uncontrolled infections or certain heart conditions.

Inclusion Criteria

Serum albumin > 2.5 g/dl

I am not on blood thinners.

My cancer has come back, hasn't responded well, or still exists after initial treatment.

+34 more

Exclusion Criteria

I or my close family had blood clots before 40, but only if not caused by a central line.

Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events

I do not have any active or uncontrolled infections.

+7 more

Participant Groups

The study tests combining sorafenib with cyclophosphamide and topotecan in children and young adults with relapsed/refractory neuroblastoma. It aims to find the highest safe dose of sorafenib when used with these drugs for this specific condition.

1Treatment groups

Experimental Treatment

Group I: Sorafenib and Cyclophosphamide/TopotecanExperimental Treatment3 Interventions

Sorafenib and Cyclophosphamide/Topotecan with growth factor support.

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

🇺🇸 Approved in United States as Cytoxan for: