Phase I Study of Bevacizumab and Sorafenib Combined With Low Dose Cyclophosphamide in Patients With Refractory Solid Tumors and Leukemia
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|ClinicalTrials.gov Identifier: NCT00665990|
Recruitment Status : Completed
First Posted : April 24, 2008
Last Update Posted : January 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Refractory Solid Tumors Leukemia||Drug: Bevacizumab Drug: Sorafenib Drug: Cyclophosphamide||Phase 1|
Phase I Study of Bevacizumab and Sorafenib Combined with Low Dose Cyclophosphamide in Patients with Refractory Solid Tumors and Leukemia. Patients with solid tumors (including central nervous tumors) that are recurrent or refractory to standard therapy, or for whom standard therapy is not available. Once a maximum tolerated dose (MTD) has been established in patients with recurrent or refractory solid tumors, the tolerability of this dose will be tested in a maximum of 6 patients, in cohorts of 3, with refractory or recurrent leukemia and a maximum of 24 evaluable patients, in cohorts of 6, with refractory or recurrent solid tumors.
Approximately 21-24 patients with refractory solid tumors to define the maximum tolerated dose (MTD) and 6 patients with recurrent or refractory leukemia,12 patients with refractory or recurrent bone or soft tissue sarcomas and 12 patients with other refractory or recurrent solid tumors (including lymphomas) to test the tolerability of this MTD in patients with hematological malignancies. Bevacizumab will be administered intravenously at a starting dose of 5 mg/kg every 3 weeks with sorafenib by mouth every 12 hrs at a starting dose of 90 mg/m2 every 12 hours and cyclophosphamide by mouth daily at a dose of 50 mg/m2/day (dose level 1). A course of therapy will be considered to be of 21 days duration. Once a maximum tolerated dose of sorafenib (sMTD) in combination with bevacizumab and cyclophosphamide has been determined, 6 patients with recurrent or refractory leukemia will be then be evaluated at the solid tumor MTD to test the tolerability of this combination in patients with hematological malignancies.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Bevacizumab and Sorafenib Combined With Low Dose Cyclophosphamide in Patients With Refractory Solid Tumors and Leukemia|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
All participants will receive bevacizumab, sorafenib, and cyclophosphamide until maximum tolerated dose is reached.
Bevacizumab starting dose of 5 mg/kg every 3 weeks increasing in combination with Sorafenib and Cyclophosphamide until maximum tolerated dose
Sorafenib 90 mg/m2 PO every 12 hours increasing in combination with Bevacizumab and Cyclophosphamide until maximum tolerated dose
Cyclophosphamide 50 mg/m2 PO once daily increasing in combination with Bevacizumab and Sorafenib until maximum tolerated dose
Other Name: Cytoxan(R)
- Determine the maximum tolerated dose and dose limiting toxicity of bevacizumab and sorafenib administered in combination with low dose cyclophosphamide to patients with refractory solid tumors. [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00665990
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105|
|Principal Investigator:||Sara Federico, MD||St. Jude Children' Research Hospital|