Leukemia Clinical Trial
Official title:
Phase I Study of Bevacizumab and Sorafenib Combined With Low Dose Cyclophosphamide in Patients With Refractory Solid Tumors and Leukemia
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 patients with refractory or recurrent leukemia and an expanded cohort of patients with refractory or recurrent solid tumors.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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