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Sorafenib and Topotecan in Refractory/Recurrent Pediatric Malignancies

NCT01683149 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2016-03-04

No results posted yet for this study

Summary

H. Lee Moffitt Cancer Center and Research Institute will be the Sunshine Project Coordinator, but will not be recruiting locally.

The purpose of this research study is to establish a dose of the combination of drugs, Topotecan and Sorafenib in children. This will be called the maximum tolerated dose. The chemotherapy in this study is a combination of Topotecan and Sorafenib. The investigators are trying to find the highest dose of Topotecan and Sorafenib that can be given safely to children with Refractory or Recurrent Pediatric Solid Malignancies. The investigators will do this by testing different doses of these drugs in different groups of children. The investigators will also study how the body processes these drugs.

Conditions

Interventions

DRUG

Topotecan

Topotecan will be given by mouth as outlined in treatment arm.

DRUG

Sorafenib

Sorafenib will be given by mouth as outlined in treatment arm.

Sponsors & Collaborators

  • Pediatric Cancer Foundation

    collaborator OTHER

  • Bayer

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Damon Reed, M.D. · H. Lee Moffitt Cancer Center and Research Institute

  • G. Douglas Letson, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01683149 on ClinicalTrials.gov