Solid Tumors
Conditions
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 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.
Interventions
DRUGDMXAA
Administered as a 20 minute IV infusion, once every three weeks at doses ranging from 6 mg/m2 to 4900 mg/m2
Sponsors
Cancer Society Auckland
Cancer Research UK
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Efficacy of DMXAA | — |
| Effect of DMXAA on tumor vasculature | — |
Outcome results
None listed