Overview

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

Status:
Completed

Trial end date:
2000-03-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Cancer Research UK

Collaborator:

Cancer Society Auckland

Treatments:

Acetic Acid
Retinol acetate
Vadimezan

Criteria

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