A Phase I Trial of 5, 6 Dimethyl Xanthenone - 4 - Acetic Acid (DMXAA) in Solid Tumors
OBJECTIVES: I. Determine the toxicity of dimethylxanthenone acetic acid (DMXAA) in patients
with solid tumors. II. Establish a maximum tolerated dose for this drug in these patients.
III. Determine the pharmacokinetics of DMXAA in these patients. IV. Determine the effect of
this regimen on coagulation parameters, TNF and other cytokine production, nitric oxide, and
serotonin production in these patients. V. Assess the efficacy of this drug in this patient
population. VI. Determine the effect of this drug on tumor vasculature by evaluating any
changes apparent on MRI scans in these patients.
OUTLINE: This is a dose escalation, multicenter study. Patients receive dimethylxanthenone
acetic acid (DMXAA) IV over 20 minutes once weekly for 6 weeks, followed by 2 weeks of rest.
An additional course of therapy may be administered in the absence of unacceptable toxicity
or disease progression. Cohorts of 3 patients receive escalated doses of DMXAA until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: A minimum of 3 patients will be accrued to each dose level used to
determine the maximum tolerated dose.
Primary Purpose: Treatment
Gordon J.S. Rustin, MD
Mount Vernon Cancer Centre at Mount Vernon Hospital
United States: Federal Government