The purpose of this study is to determine the safety of bavituximab when administered via a vein, and to examine how bavituximab behaves in the body - how quickly it is taken up by the body and how long it stays there. The effect of bavituximab on tumor responses will also be examined.
The genetic variations observed in most advanced cancers decrease the effectiveness of many anti-cancer agents through the development of drug resistance. Therefore, alternative approaches to the direct targeting of cancer cells are urgently needed. Bavituximab is the generic name for a chimeric (human/murine) monoclonal antibody directed against aminophospholipids. Bavituximab is Peregrine's first investigational product under its anti-phospholipid therapy technology platform. Anti-phospholipid therapy is a novel approach to treating cancer. It is based on the finding that aminophospholipids, which are basic components of the inner surface of cells become externally exposed in response to certain disease states such as cancer. Laboratory and animal studies have demonstrated that bavituximab specifically targets cancer cells and inhibits tumor growth in a variety of experimental cancer models. This study will examine the safety and tolerability of bavituximab when administered to patients with advanced solid tumor cancers that are unresponsive to current therapies. Cohorts of 6 patients each will be treated at the starting dose of 0.1 mg bavituximab per kilogram body weight (0.1 mg/kg). Successive patient cohorts will receive 0.3, 1.0 and 3.0 mg/kg of bavituximab. Patients will be followed for a total of 56 days. Patients who demonstrate an objective tumor response will be offered further bavituximab treatment on an extension protocol.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Bavituximab is a sterile drug solution supplied in glass bottles. Bavituximab will be intravenously administered over approximately 90 minutes on days 0, 7, 14 and 21 (dosage determined based on dose cohort and body weight).
Arizona Cancer Center
Tucson, Arizona, United States
Premiere Oncology
Santa Monica, California, United States
The West Clinic
Memphis, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
adverse events
Time frame: Study Completion
laboratory evaluations
Time frame: Study Completion
human anti-chimeric antibody
Time frame: Study Completion
pharmacokinetic analysis
Time frame: Study Completion
tumor evaluation by Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Study Completion
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MD Anderson Cancer Center
Houston, Texas, United States
Scott & White Hospital, Center for Cancer Prevention and Care
Temple, Texas, United States