Trial | NCT00863733  Report issue

Title

Study of DMXAA (Now Known as ASA404) in Solid Tumors
Phase I Trial of 5,6 Dimethylxanthenone - 4 - Acetic Acid (DMXAA) in Solid Tumors

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    63
This is a phase I study aimed at identifying safe doses of DMXAA in patients with 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.
Study Started
May 31
1996
Primary Completion
Mar 31
2000
Study Completion
Mar 31
2000
Last Update
Mar 18
2009
Estimate

Drug DMXAA

Administered as a 20 minute IV infusion, once every three weeks at doses ranging from 6 mg/m2 to 4900 mg/m2

  • Other names: 5,6 Dimethylxanthenone-4-Acetic Acid, ASA404, AS1404, NSC-640488

Criteria 

Inclusion Criteria:

Histologically confirmed solid tumor that is not amenable to any standard therapy or is refractory to conventional therapy
Performance status WHO 0-2
Life expectancy greater than 3 months
Hemoglobin at least 90 g/L; WBC at least 3,000/mm3; Platelet count at least 100,000/mm3
Bilirubin within normal limits; ALT less than 2 times upper limit of normal (ULN); Alkaline phosphatase less than 2 times ULN
Creatinine less than 130 umol/L
INR and APTT within normal limits
Fertile patients must use effective contraception
At least 4 weeks since prior anticancer therapy and recovered from toxic effects

Exclusion Criteria:

Concurrent malignancy except cone biopsied carcinoma in situ of the cervix and adequately treated basal or squamous cell carcinoma of the skin
Other serious medical condition
Uncontrolled infection or serious infection within the past 28 days
Pregnant or lactating
Treatment with glucocorticosteroids within previous two weeks
No Results Posted