Sorafenib and Topotecan in Refractory/Recurrent Pediatric Malignancies
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I, Traditional 3+3, Trial of PO Sorafenib and Topotecan in Refractory or Recurrent Pediatric Solid Malignancies|
- Maximum Tolerated Dose (MTD) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]Establish the recommended phase II dose of the combination of topotecan and sorafenib in children. This will be the maximum tolerated dose.
- Time to Progression (TTP) [ Time Frame: 24 months ] [ Designated as safety issue: No ]Determine Time to Progression (TTP) for all patients, comparing TTP on study to TTP on previous regimen. This study will use the (RECIST 1.1) Response Evaluation Criteria in Solid Tumors from the NCI for assessment of radiographic response in patients with solid tumors and in order to determine if patients have met off study criteria, i.e. disease progression. Progressive Disease (PD): At least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of laboratory or clinical progression.
- The Number of Participants with Adverse Events as a Measure of Safety and Feasibility [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]Describe the toxicity as per NCI Common Toxicity Criteria, version 4.0 (CTCAE 4.0).
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Experimental: Combination Chemotherapy
Combination Chemotherapy: Topotecan and Sorafenib. Participants will receive the treatment in cycles. Every cycle is 28 days long. For the first cycle participants will get the chemotherapy drugs:
Topotecan will be given by mouth as outlined in treatment arm.
Other Name: Topoisomerase-I inhibitorDrug: Sorafenib
Sorafenib will be given by mouth as outlined in treatment arm.
Other Name: BAY 43-9006
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683149
|United States, California|
|Childrens Hospital Los Angeles|
|Los Angeles, California, United States, 90027|
|United States, Connecticut|
|Connecticut Childrens Medical Center|
|Hartford, Connecticut, United States, 06106|
|United States, Delaware|
|Nemours/Alfred I. duPont Hospital for Children, Delaware|
|Wilmington, Delaware, United States, 19803|
|United States, Florida|
|University of Florida, Gainesville|
|Gainesville, Florida, United States, 32610|
|Nemours Children's Clinic, Jacksonville|
|Jacksonville, Florida, United States, 32207|
|University of Miami, Sylvester Comprehensive Cancer Center|
|Miami, Florida, United States, 33136|
|All Children's Hospital, St. Petersburg|
|St. Petersburg, Florida, United States, 33701|
|United States, New York|
|Montefiore Medical Center, Children's Hospital at Montefiore|
|Bronx, New York, United States, 10467|
|United States, Utah|
|Primary Children's Medical Center/Utah|
|Salt Lake City, Utah, United States, 84113|
|Principal Investigator:||Damon Reed, M.D.||H. Lee Moffitt Cancer Center and Research Institute|
|Principal Investigator:||G. Douglas Letson, M.D.||H. Lee Moffitt Cancer Center and Research Institute|