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

Solid Tumors Clinical Trial

— DMXAA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00863733
• Other study ID #: PHI/050
• Status: Completed
• Phase: Phase 1
• First received: March 17, 2009
• Last updated: March 17, 2009
• Start date: May 1996
• Est. completion date: March 2000

Study information

• Verified date: March 2009
• Source: Cancer Research UK
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Health Research Council
• Study type: Interventional

Clinical Trial Summary

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

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 2000
• Est. primary completion date: March 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 100,000/mm3

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

Study Design

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

Related Conditions & MeSH terms

• Solid Tumors

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Cancer Research UK	Cancer Society Auckland

References & Publications (1)

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity of DMXAA			Yes
Primary	Maximum tolerated dose of DMXAA			Yes
Primary	Pharmacokinetics of DMXAA			No
Primary	Effect of DMXAA on coagulation parameters, TNF and other cytokine production, nitric oxide, and serotonin production			No
Secondary	Efficacy of DMXAA			No
Secondary	Effect of DMXAA on tumor vasculature			No