Study of Immune Response Modifier in the Treatment of Hematologic Malignancies
|ClinicalTrials.gov Identifier: NCT00276159|
Recruitment Status : Terminated (Drug was not available.)
First Posted : January 13, 2006
Results First Posted : May 5, 2010
Last Update Posted : December 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Non-Hodgkin's Lymphoma Hodgkin's Lymphoma Multiple Myeloma Chronic Lymphocytic Leukemia||Drug: 852A||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of 852A Administered Subcutaneously in Patients With Hematologic Malignancies Not Responding to Standard Treatment|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
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.
- Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors [ Time Frame: Up to Week 12 ]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 ]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 ]
- Peak Concentrations of 852A [ Time Frame: Up to Week 12 ]Measurement of peak concentrations of 852A to correlate the side effects of tolerability in patients.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276159
|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|