Study of Immune Response Modifier in the Treatment of Hematologic Malignancies
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.
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Chronic Lymphocytic Leukemia
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of 852A Administered Subcutaneously in Patients With Hematologic Malignancies Not Responding to Standard Treatment|
- Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]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.
- Number of Patients Who Received Steroids [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]Number of patients who received steroids allowing successful continuation of therapy.
- Measure of Immune Activation With Correlative Laboratory Studies [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]
- Peak Concentrations of 852A [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]Measurement of peak concentrations of 852A to correlate the side effects of tolerability in patients.
|Study Start Date:||January 2006|
|Study Completion Date:||November 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Experimental: 852A Treatment
Patients receiving at least one dose of 852A.
Subcutaneous injection 0.6 mg/m2 2 times/week/12 weeks, may increase by 0.2 mg/m2 up to 1.2 mg/m2.
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
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Sarah Cooley, MD||Masonic Cancer Center, University of Minnesota|