Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003697
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Dimethylxanthenone Acetic Acid in Treating Patients With Solid Tumors
Sponsor:
University of Glasgow
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of 5 6 Dimethyl Xanthenone - 4 - Acetic Acid DMXAA in Solid Tumors
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-98065 | None | None | None |
| CRC-PHASE-III-PH1048 | None | None | None |