Phase I Study of MGI-114 (NSC#683863) in Patients With Refractory Myelodysplastic Syndromes, Acute Leukemia and Chronic Myelogenous Leukemia in Blastic Phase (CML-BP)
I. Determine the maximum tolerated dose for 6-hydroxymethylacylfulvene in patients with
refractory myelodysplastic syndrome, acute myeloid leukemia, acute lymphocytic leukemia, or
blastic phase chronic myelogenous leukemia.
II. Determine the qualitative and quantitative toxicities of this treatment in these
III. Determine the duration and reversibility of the qualitative and quantitative toxicities
of this treatment in these patients.
IV. Evaluate, in a preliminary manner, the antileukemic activity of this treatment in these
V. Assess relative mRNA levels of selected NER genes (ERCC1, ERCC2, and ERCC3) in tumor
tissues of patients treated with this regimen and correlate with clinical outcome.
OUTLINE: This is a dose escalation study.
Patients receive 6-hydroxymethylacylfulvene (HMAF) IV over 5 minutes on days 1-5. Treatment
repeats every 3-4 weeks for at least 2 courses in the absence of disease progression or
unacceptable toxicity. Cohorts of 3 patients receive escalating doses of HMAF. The maximum
tolerated dose is defined as the dose at which dose limiting toxicity occurs in at least 40%
Patients are followed every 3 months for 1 year and then every 6 months thereafter.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Francis J. Giles, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|University of Texas - MD Anderson Cancer Center
|Houston, Texas 77030-4009