Clinical trialNCT01683149CompletedPhase 1Interventional

Sorafenib and Topotecan in Refractory/Recurrent Pediatric Malignancies

SponsorH. Lee Moffitt Cancer Center and Research InstituteEnrollment13Solid Tumor

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Damon Reed, M.D.
H. Lee Moffitt Cancer Center and Research Institute
Principal Investigator
clinicaltrials.gov ↗
G. Douglas Letson, M.D.
H. Lee Moffitt Cancer Center and Research Institute
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

9 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Childrens Hospital Los Angeles
Los Angeles, California, United States
Connecticut Childrens Medical Center
Hartford, Connecticut, United States
Nemours/alfred I. Dupont Hospital for Children, Delaware
Wilmington, Delaware, United States
University of Florida, Gainesville
Gainesville, Florida, United States
Nemours Children'S Clinic, Jacksonville
Jacksonville, Florida, United States
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, United States
All Children'S Hospital, St. Petersburg
St. Petersburg, Florida, United States
Montefiore Medical Center, Children'S Hospital at Montefiore
The Bronx, New York, United States
Primary Children'S Medical Center/utah
Salt Lake City, Utah, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Sorafenib →Topotecan →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Jan 2013
Primary completion: 31 Jan 2016
Completion: 31 Jan 2016
Last update posted: 4 Mar 2016
Registered enrollment: 13
Registry id: NCT01683149

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.