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

Phase 1
18 Years
Not Enrolling
Solid Tumors

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Trial Information

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

This is a dose escalation study conducted at a single center in New Zealand. Patients
received dimethylxanthenone acetic acid (DMXAA) IV over 20 minutes once every three weeks,
up to a maximum of 12 courses.

Cohorts of 3 patients received escalated doses of DMXAA until the maximum tolerated dose
(MTD) was determined. The MTD is defined as the dose preceding that at which 2 of 3 patients
experience dose limiting toxicity.

Patients had solid tumors for which there was no standard therapy or were refractory to
conventional therapy.

Inclusion Criteria:

1. Histologically confirmed solid tumor that is not amenable to any standard therapy or
is refractory to conventional therapy

2. Performance status WHO 0-2

3. Life expectancy greater than 3 months

4. Hemoglobin at least 90 g/L; WBC at least 3,000/mm3; Platelet count at least

5. Bilirubin within normal limits; ALT less than 2 times upper limit of normal (ULN);
Alkaline phosphatase less than 2 times ULN

6. Creatinine less than 130 umol/L

7. INR and APTT within normal limits

8. Fertile patients must use effective contraception

9. At least 4 weeks since prior anticancer therapy and recovered from toxic effects

Exclusion Criteria:

1. Concurrent malignancy except cone biopsied carcinoma in situ of the cervix and
adequately treated basal or squamous cell carcinoma of the skin

2. Other serious medical condition

3. Uncontrolled infection or serious infection within the past 28 days

4. Pregnant or lactating

5. Treatment with glucocorticosteroids within previous two weeks

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity of DMXAA

Safety Issue:


Principal Investigator

Dr Paul Thompson

Investigator Role:

Principal Investigator

Investigator Affiliation:

Auckland Hospital


New Zealand: Health Research Council

Study ID:




Start Date:

May 1996

Completion Date:

March 2000

Related Keywords:

  • Solid Tumors
  • Neoplasms