Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130442
Status:
COMPLETED
Last Update Posted:
2022-06-23
First Post:
2005-08-12
Brief Title:
Trial of PI-88 With Dacarbazine in Patients With Metastatic Melanoma
Sponsor:
Cellxpert Biotechnology Corp
Organization:
Cellxpert Biotechnology Corp
Study Overview
Official Title:
A Phase II Study of PI-88 With Dacarbazine in Patients With Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2022-06
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:
The aim of the study is to compare the safety and effectiveness of a new drug called PI-88 when used in combination with an approved chemotherapy drug called dacarbazine in the treatment of metastatic melanoma
PI-88 blocks new blood vessel growth in tumours starves it of nutrients and dacarbazine stops the cancer cells from growing The results from this study will be analysed to see if it is worthwhile for the two drugs to be tested in future studies involving larger numbers of melanoma patients
PI-88 blocks new blood vessel growth in tumours starves it of nutrients and dacarbazine stops the cancer cells from growing The results from this study will be analysed to see if it is worthwhile for the two drugs to be tested in future studies involving larger numbers of melanoma patients
Detailed Description:
Metastatic melanoma is a difficult-to-treat cancer for which available treatment options are limited and minimally effective Dacarbazine is currently one of the standard chemotherapy drugs used for the treatment of metastatic melanoma However it is associated with low response rates 10-20 and median survival of less than 12 months 6-11 months in most studies PI-88 is an antiangiogenic and antimetastatic drug that has already shown some evidence of efficacy when used alone in an intermittent dosage regimen 4 consecutive days per week in the treatment of patients with advanced melanoma The FDA has designated PI-88 as an Orphan Drug for this indication as well as for Stage III and high-risk stage II disease The aim of this randomised pilot phase II trial is to determine whether PI-88 in combination with a standard regimen of dacarbazine 1000 mgm2 every 3 weeks should be considered for further investigation in a larger-scale trial
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