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

This study has been completed.
Sponsor:
Collaborator:
Cancer Society Auckland
Information provided by:
Cancer Research UK
ClinicalTrials.gov Identifier:
NCT00863733
First received: March 17, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial of 5,6 Dimethylxanthenone - 4 - Acetic Acid (DMXAA) in Solid Tumors

Resource links provided by NLM:


Further study details as provided by Cancer Research UK:

Primary Outcome Measures:
  • Toxicity of DMXAA [ Designated as safety issue: Yes ]
  • Maximum tolerated dose of DMXAA [ Designated as safety issue: Yes ]
  • Pharmacokinetics of DMXAA [ Designated as safety issue: No ]
  • Effect of DMXAA on coagulation parameters, TNF and other cytokine production, nitric oxide, and serotonin production [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy of DMXAA [ Designated as safety issue: No ]
  • Effect of DMXAA on tumor vasculature [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00863733

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

Publications:
Responsible Party: Dr Paul Thompson, Auckland Hospital
ClinicalTrials.gov Identifier: NCT00863733     History of Changes
Other Study ID Numbers: PHI/050
Study First Received: March 17, 2009
Last Updated: March 17, 2009
Health Authority: New Zealand: Health Research Council

Additional relevant MeSH terms:
Neoplasms
Vadimezan
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014