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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00074750 on ClinicalTrials.gov