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Completed

NCT Number: NCT00863733

Study of DMXAA (Now Known as ASA404) in Solid Tumors

This is a phase I study aimed at identifying safe doses of DMXAA in patients with solid tumors.

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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DMXAA

Drug

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

Primary outcomes

  1. Toxicity of DMXAA

  2. Maximum tolerated dose of DMXAA

  3. Pharmacokinetics of DMXAA

  4. Effect of DMXAA on coagulation parameters, TNF and other cytokine production, nitric oxide, and serotonin production

Secondary outcomes

  1. Efficacy of DMXAA

  2. Effect of DMXAA on tumor vasculature

Sponsors and collaborators

Lead sponsor

Cancer Research UK

Other

Collaborators

  • Cancer Society Auckland

Registry information

Official study title

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

Acronym: DMXAA

Important dates

Study start
1996
Primary completion
2000
Study completion
2000
First posted
Mar 18, 2009
Registry last updated
Mar 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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