Full Text View
Tabular View
No Study Results Posted
Related Studies
Dimethylxanthenone Acetic Acid in Treating Patients With Solid Tumors
This study is ongoing, but not recruiting participants.
Study NCT00003697   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: June 17, 2009   History of Changes

November 1, 1999
June 17, 2009
October 1995
 
 
 
Complete list of historical versions of study NCT00003697 on ClinicalTrials.gov Archive Site
 
 
 
Dimethylxanthenone Acetic Acid in Treating Patients With Solid Tumors
A Phase I Trial of 5, 6 Dimethyl Xanthenone - 4 - Acetic Acid (DMXAA) in Solid Tumors

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.

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.

Phase I
Interventional
Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Drug: dimethylxanthenone acetic acid
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
3
 
 

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

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00003697
 
CDR0000066804, CRC-PHASE-I/II-PH1/048, EU-98065
University of Glasgow
 
Study Chair: Gordon J.S. Rustin, MD Mount Vernon Cancer Centre at Mount Vernon Hospital
National Cancer Institute (NCI)
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP