Valproic Acid Injection |
Depacon; Valproate Sodium |
Clinical Trial: Dimethylxanthenone Acetic Acid in Treating Patients With Solid Tumors
This study is no longer recruiting patients.
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| unspecified adult solid tumor, protocol specific | Drug: dimethylxanthenone acetic acid | Phase I |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of Dimethylxanthenone Acetic Acid in Patients with Solid Tumors
Study start: October 1995
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.
PROTOCOL 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 - 75 Years
Criteria
PROTOCOL ENTRY 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
--Prior/Concurrent Therapy--
- At least 4 weeks since prior anticancer therapy (6 weeks for nitrosoureas and mitomycin) and recovered
--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
Location Information
United Kingdom, England
Mount Vernon Hospital, Northwood, England, HA6 2RN, United Kingdom
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: May 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00003697
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Depacon (Drug Digest)
- Valproate Sodium (Drug Digest)

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