Dose Escalation Study of Sorafenib and Irinotecan Combination Therapy in Pediatric Patients With Solid Tumors
|ClinicalTrials.gov Identifier: NCT01518413|
Recruitment Status : Completed
First Posted : January 26, 2012
Last Update Posted : February 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Rhabdomyosarcoma and Other Soft Tissue Sarcomas Ewing's Sarcoma Family of Tumors Osteosarcoma Neuroblastoma Brain Tumors||Drug: sorafenib Drug: irinotecan||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Dose Escalation Study of Sorafenib and Irinotecan Combination Therapy in Pediatric Patients With Relapsed or Refractory Solid Tumors|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Experimental: Combination Therapy
Three to 6 patient will be enrolled at each dose level and dose escalations will proceed in the absence of dose-limiting toxicity attributed to therapy, first with dose escalation of sorafenib and then, if tolerated, escalation of irinotecan.
sorafenib (50 and 200 mg tablets) orally twice daily, on a continuous schedule at a starting dose of 150mg/m2/dose.
irinotecan (70 mg/m2/dose) orally, concurrently, once daily,starting at the beginning of the 21 day cycle,repeated every 21 days
- Toxicity Profile [ Time Frame: 24 months ]Determine the toxicity profile, dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of sorafenib, when administered in combination with oral irinotecan in children with relapsed or refractory solid tumors.
- Patient Related Outcomes [ Time Frame: 24 months ]
Demonstrate the feasibility of incorporating measurement of patient-related outcome into a four site phase 1 trial of sorafenib and irinotecan for children and adolescents.
Demonstrate feasibility: defined as 70% of participants will complete the 5 patient-reported outcomes (PROs) (pain, fatigue, worry, sadness and physical functioning) at both baseline (pre-treatment) and at the end of the first course and missing data will not be greater than 15% across the 5 PROs at either data point.
- Pharmacokinetic Profile [ Time Frame: 24 months ]Describe the plasma pharmacokinetic profile of sorafenib and irinotecan when administered as combination therapy in children and adolescents.
- Disease Evaluation [ Time Frame: 24 months ]Evaluate disease response, based on criteria for measurable lesions (RECIST) and evaluable lesions, to guide further development in phase 2 studies.
- Integration of Patient Related Outcomes with other outcome measures [ Time Frame: 24 months ]Correlate and integrate the PRO scores with traditional endpoints of toxicity, pharmacokinetic profile, and tumor response associated with the sorafenib and irinotecan combination.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01518413
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010|
|United States, Maryland|
|National Cancer Institute|
|Bethesda, Maryland, United States, 20892|
|United States, Massachusetts|
|Children's Hospital Boston/Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Holly Meany, MD||Children's Research Institute|