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

March 17, 2009 updated by: Cancer Research UK

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
Efficacy of DMXAA
Effect of DMXAA on tumor vasculature

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Research UK

Collaborators

Cancer Society Auckland

Investigators

  • Principal Investigator: Dr Paul Thompson, Auckland Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1996

Primary Completion (Actual)

March 1, 2000

Study Completion (Actual)

March 1, 2000

Study Registration Dates

First Submitted

March 17, 2009

First Submitted That Met QC Criteria

March 17, 2009

First Posted (Estimate)

March 18, 2009

Study Record Updates

Last Update Posted (Estimate)

March 18, 2009

Last Update Submitted That Met QC Criteria

March 17, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHI/050

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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