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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00863733
First Posted: March 18, 2009
Last Update Posted: March 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Cancer Society Auckland
Information provided by:
Cancer Research UK
  Purpose
This is a phase I study aimed at identifying safe doses of DMXAA in patients with solid tumors.

Condition Intervention Phase
Solid Tumors Drug: DMXAA Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of 5,6 Dimethylxanthenone - 4 - Acetic Acid (DMXAA) in Solid Tumors

Further study details as provided by Cancer Research UK:

Primary Outcome Measures:
  • 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:
  • Efficacy of DMXAA
  • Effect of DMXAA on tumor vasculature

Enrollment: 63
Study Start Date: May 1996
Study Completion Date: March 2000
Primary Completion Date: March 2000 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: DMXAA
    Administered as a 20 minute IV infusion, once every three weeks at doses ranging from 6 mg/m2 to 4900 mg/m2
    Other Names:
    • 5,6 Dimethylxanthenone-4-Acetic Acid
    • ASA404
    • AS1404
    • NSC-640488
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00863733


Sponsors and Collaborators
Cancer Research UK
Cancer Society Auckland
Investigators
Principal Investigator: Dr Paul Thompson Auckland Hospital
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Paul Thompson, Auckland Hospital
ClinicalTrials.gov Identifier: NCT00863733     History of Changes
Other Study ID Numbers: PHI/050
First Submitted: March 17, 2009
First Posted: March 18, 2009
Last Update Posted: March 18, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Retinol acetate
Vadimezan
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents