Dimethylxanthenone Acetic Acid in Treating Patients With Solid Tumors - Full Text View

Sponsored by:	University of Glasgow
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003697

Purpose

RATIONALE: Dimethylxanthenone acetic acid may stop the growth of cancer cells by stopping blood flow to the tumor.

PURPOSE: Phase I trial to study the effectiveness of dimethylxanthenone acetic acid in treating patients with solid tumors that have not responded to previous therapy.

Condition	Intervention	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Drug: dimethylxanthenone acetic acid	Phase I

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase I Trial of 5, 6 Dimethyl Xanthenone - 4 - Acetic Acid (DMXAA) in Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Acetic acid 5,6-Dimethylxanthenoneacetic acid

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	3
Study Start Date:	October 1995

Detailed Description:

OBJECTIVES: I. Determine the toxicity of dimethylxanthenone acetic acid (DMXAA) in patients with solid tumors. II. Establish a maximum tolerated dose for this drug in these patients. III. Determine the pharmacokinetics of DMXAA in these patients. IV. Determine the effect of this regimen on coagulation parameters, TNF and other cytokine production, nitric oxide, and serotonin production in these patients. V. Assess the efficacy of this drug in this patient population. VI. Determine the effect of this drug on tumor vasculature by evaluating any changes apparent on MRI scans in these patients.

OUTLINE: This is a dose escalation, multicenter study. Patients receive dimethylxanthenone acetic acid (DMXAA) IV over 20 minutes once weekly for 6 weeks, followed by 2 weeks of rest. An additional course of therapy may be administered in the absence of unacceptable toxicity or disease progression.

Cohorts of 3 patients receive escalated doses of DMXAA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicity.

PROJECTED ACCRUAL: A minimum of 3 patients will be accrued to each dose level used to determine the maximum tolerated dose.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed solid tumor that is not amenable to any standard therapy or is refractory to conventional therapy Tumor mass larger than 3 cm accessible to MRI scan Documented progression within the past 2 months

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-2 Life expectancy: Greater than 3 months Hematopoietic: Hemoglobin at least 9 g/dL WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.2 mg/dL ALT less than 2 times upper limit of normal (ULN) Alkaline phosphatase less than 2 times ULN Renal: Creatinine less than 1.5 mg/dL Other: Fertile patients must use effective contraception No concurrent malignancy except cone biopsied carcinoma in situ of the cervix and adequately treated basal or squamous cell carcinoma of the skin No other serious medical condition No uncontrolled infection or serious infection within the past 28 days Must live within 1 hour of Mount Vernon Hospital, UK

PRIOR CONCURRENT THERAPY: At least 4 weeks since prior anticancer therapy (6 weeks for nitrosoureas and mitomycin) and recovered

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003697

Locations

United Kingdom, England
Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN

Sponsors and Collaborators

University of Glasgow

Investigators

Study Chair:

Gordon J.S. Rustin, MD

Mount Vernon Cancer Centre at Mount Vernon Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Rustin GJ, Galbraith S, Taylor N, et al.: Impact on tumour perfusion measured by dynamic magnetic resonance imaging (MRI) in the phase I trial of 5,6-dimethyl xanthenone-4-acetic acid (DMXAA). [Abstract] Ann Oncol 9 (suppl 2): A-483, 126, 1998.

Jameson M, Thompson P, Baguley B, et al.: Comparative pharmacokinetics and plasma protein binding of the novel anti-cancer agent 5,6-dimethylxanthenone-4-acetic acid in humans and mice. [Abstract] Proceedings of the American Society of Clinical Oncology A-746, 1997.

Jameson MB, Sharp DM, Sissingh JI, Hogg CR, Thompson PI, McKeage MJ, Jeffery M, Waller S, Acton G, Green C, Baguley BC. Transient retinal effects of 5,6-dimethylxanthenone-4-acetic acid (DMXAA, ASA404), an antitumor vascular-disrupting agent in phase I clinical trials. Invest Ophthalmol Vis Sci. 2009 Jun;50(6):2553-9. Epub 2009 Apr 22.

Study ID Numbers:	CDR0000066804, CRC-PHASE-I/II-PH1/048, EU-98065
Study First Received:	November 1, 1999
Last Updated:	June 17, 2009
ClinicalTrials.gov Identifier:	NCT00003697 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Retinol
Anticarcinogenic Agents
5,6-dimethylxanthenoneacetic acid
Immunologic Factors
Retinol palmitate

Vitamin A
Retinol acetate
Adjuvants, Immunologic
Acetic Acid

Additional relevant MeSH terms:

Anticarcinogenic Agents
5,6-dimethylxanthenoneacetic acid
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Retinol acetate
Adjuvants, Immunologic
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009