Dimethylxanthenone Acetic Acid in Treating Patients With Solid Tumors

NCT00003697 | Completed Phase 1

• 3 other identifiers: CDR0000066804CRC-PHASE-I/II-PH1/048EU-98065
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

vadimezan DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Glasgow: lead

Study Sites (1)

Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Related Publications (3)

• 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. doi: 10.1167/iovs.08-2068. Epub 2009 Apr 22.

  PMID: 19387077 BACKGROUND

• 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.

  RESULT

• 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.

  RESULT

MeSH Terms

Interventions

vadimezan

Study Officials

• Gordon J.S. Rustin, MD

  Mount Vernon Cancer Centre at Mount Vernon Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 20, 2004
• Study Start: October 1, 1995
• Study Completion: December 1, 1998
• Last Updated: December 19, 2013

Record last verified: 2009-06

Locations

GB (1)