Sorafenib and Cyclophosphamide/Topotecan in Patients With Relapsed and Refractory Neuroblastoma

Summary

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.

Conditions

• Neuroblastoma

Interventions

DRUG

Sorafenib

Sorafenib -100-200mg/m2/dose (dose escalation), Orally BID continuously Days 1 thru 28 Cyclophosphamide - 250 mg/m2/day IV x 5 days - day 1 thru day 5 Topotecan - 0.75 mg/m2/day IV x 5 days - day 1 thru day 5

DRUG

Cyclophosphamide

250mg/m2/day IV x5 days (Day 1 through Day 5 of each course)

DRUG

Topotecan

0.75mg/m2.day IV x5 days (Day 1 through Day 5 of each course)

Sponsors & Collaborators

• University of California, San Francisco

  collaborator OTHER

• Children's Hospital Los Angeles

  collaborator OTHER

• Lucile Packard Children's Hospital

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• Seattle Children's Hospital

  collaborator OTHER

• Dana-Farber Cancer Institute

  collaborator OTHER

• The Hospital for Sick Children

  collaborator OTHER

• Children's Healthcare of Atlanta

  collaborator OTHER

• University of Chicago

  collaborator OTHER

• Cook Children's Health Care System

  collaborator OTHER

• Children's Hospital Colorado

  collaborator OTHER

• New Approaches to Neuroblastoma Therapy Consortium

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-10-08

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• United States
• Canada

Study Locations