Study of DMXAA (Now Known as ASA404) in Solid Tumors
DMXAA
Phase I Trial of 5,6 Dimethylxanthenone - 4 - Acetic Acid (DMXAA) in Solid Tumors
1 other identifier
interventional
63
0 countries
N/A
Brief Summary
This is a phase I study aimed at identifying safe doses of DMXAA in patients with solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 1996
Longer than P75 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 1996
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2000
CompletedFirst Submitted
Initial submission to the registry
March 17, 2009
CompletedFirst Posted
Study publicly available on registry
March 18, 2009
CompletedMarch 18, 2009
March 1, 2009
3.8 years
March 17, 2009
March 17, 2009
Conditions
Outcome Measures
Primary Outcomes (4)
Toxicity of DMXAA
Maximum tolerated dose of DMXAA
Pharmacokinetics of DMXAA
Effect of DMXAA on coagulation parameters, TNF and other cytokine production, nitric oxide, and serotonin production
Secondary Outcomes (2)
Efficacy of DMXAA
Effect of DMXAA on tumor vasculature
Interventions
Administered as a 20 minute IV infusion, once every three weeks at doses ranging from 6 mg/m2 to 4900 mg/m2
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cancer Research UKlead
- Cancer Society Aucklandcollaborator
Related Publications (2)
Jameson MB, Thompson PI, Baguley BC, Evans BD, Harvey VJ, Porter DJ, McCrystal MR, Small M, Bellenger K, Gumbrell L, Halbert GW, Kestell P; Phase I/II Trials Committee of Cancer Research UK. Clinical aspects of a phase I trial of 5,6-dimethylxanthenone-4-acetic acid (DMXAA), a novel antivascular agent. Br J Cancer. 2003 Jun 16;88(12):1844-50. doi: 10.1038/sj.bjc.6600992.
PMID: 12799625RESULTJameson MB, Sharp DM, Sissingh JI, Hogg CR, Thompson PI, McKeage MJ, Jeffery M, Waller S, Acton G, Green C, Baguley BC. Transient retinal effects of 5,6-dimethylxanthenone-4-acetic acid (DMXAA, ASA404), an antitumor vascular-disrupting agent in phase I clinical trials. Invest Ophthalmol Vis Sci. 2009 Jun;50(6):2553-9. doi: 10.1167/iovs.08-2068. Epub 2009 Apr 22.
PMID: 19387077DERIVED
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Dr Paul Thompson
Auckland Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 17, 2009
First Posted
March 18, 2009
Study Start
May 1, 1996
Primary Completion
March 1, 2000
Study Completion
March 1, 2000
Last Updated
March 18, 2009
Record last verified: 2009-03