Status:
COMPLETED
Study of DMXAA (Now Known as ASA404) in Solid Tumors
Lead Sponsor:
Cancer Research UK
Collaborating Sponsors:
Cancer Society Auckland
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a phase I study aimed at identifying safe doses of DMXAA in patients with solid tumors.
Detailed Description
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2000
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00863733
Start Date
May 1 1996
End Date
March 1 2000
Last Update
March 18 2009
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