Study of DT388GMCSF Fusion Protein in Acute Myelogenous Leukemia (AML) and Chronic Myelomonocytic Leukemia (CMML)
NCT00074750 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2012-02-22
Summary
DTGM belongs to a new generation of drugs designed to target leukemic cells. To achieve this, DTGM takes advantage of the ability of naturally-produced growth factor (GM, granulocyte-macrophage stimulating factor) to deliver a drug (diphtheria toxin) to cells; preferably leukemic cells. It then attaches to the cells and allows the toxin to enter the leukemic cells and destroy them.
Conditions
- Acute Myelogenous Leukemia
- Chronic Myelomonocytic Leukemia
Interventions
- DRUG
-
DTGM
Starting dose: 2 mcg/kg by vein three times a week (M,W,F) for two consecutive weeks.
Sponsors & Collaborators
-
Wake Forest University
collaborator OTHER -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Miloslav Beran, MD, PhD, DVM · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-12-31
- Primary Completion
- 2004-12-31
- Completion
- 2004-12-31
Countries
- United States
Study Locations
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