The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat certain hematologic malignancies not responding to standard treatment.
852A will be administered as a subcutaneous injection (SC) 2 times per week for 12 weeks (24 doses) with provisions for dose escalation or reduction based on tolerability
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Subcutaneous injection 0.6 mg/m2 2 times/week/12 weeks, may increase by 0.2 mg/m2 up to 1.2 mg/m2.
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors
Stable disease in Non-Hogkin's Lymphoma = disease that does not satisfy complete (complete regression), partial (\> or = 50% reduction) or progressive disease (increase of 25%) by at least a 4-week period. Since Acute Myelogenous Leukemia is not a solid tumor, Complete Response (CR) = \<5% blasts with hematopoietic recovery (absolute neutrophil count \>500) at 4 weeks.
Time frame: Up to Week 12
Number of Patients Who Received Steroids
Number of patients who received steroids allowing successful continuation of therapy.
Time frame: Up to Week 12
Measure of Immune Activation With Correlative Laboratory Studies
Time frame: Up to Week 12
Peak Concentrations of 852A
Measurement of peak concentrations of 852A to correlate the side effects of tolerability in patients.
Time frame: Up to Week 12
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