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A Phase I Trial of 5, 6 Dimethyl Xanthenone - 4 - Acetic Acid (DMXAA) in Solid Tumors

Phase 1
18 Years
75 Years
Open (Enrolling)
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed solid tumor that is not amenable to any
standard therapy or is refractory to conventional therapy Tumor mass larger than 3 cm
accessible to MRI scan Documented progression within the past 2 months

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-2 Life expectancy:
Greater than 3 months Hematopoietic: Hemoglobin at least 9 g/dL WBC at least 3,000/mm3
Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.2 mg/dL ALT less than 2
times upper limit of normal (ULN) Alkaline phosphatase less than 2 times ULN Renal:
Creatinine less than 1.5 mg/dL Other: Fertile patients must use effective contraception No
concurrent malignancy except cone biopsied carcinoma in situ of the cervix and adequately
treated basal or squamous cell carcinoma of the skin No other serious medical condition No
uncontrolled infection or serious infection within the past 28 days Must live within 1
hour of Mount Vernon Hospital, UK

PRIOR CONCURRENT THERAPY: At least 4 weeks since prior anticancer therapy (6 weeks for
nitrosoureas and mitomycin) and recovered

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Gordon J.S. Rustin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mount Vernon Cancer Centre at Mount Vernon Hospital


United States: Federal Government

Study ID:




Start Date:

October 1995

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms