Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039000
Status:
COMPLETED
Last Update Posted:
2012-09-07
First Post:
2002-06-06
Brief Title:
Study of Heat Shock Protein-Peptide Complex HSPPC-96 Versus IL-2DTIC for Stage IV Melanoma
Sponsor:
Agenus Inc
Organization:
Agenus Inc
Study Overview
Official Title:
A Phase III Study of Heat Shock Protein-Peptide Complex HSPPC-96 Versus Physicians Choice Including Interleukin-2 andor DacarbazineTemozolomide-based Therapy andor Complete Tumor Resection in Stage IV Melanoma
Status:
COMPLETED
Status Verified Date:
2012-09
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 primary goal of this study is to determine if people with metastatic melanoma who receive Heat Shock Protein-Peptide Complex - 96 HSPPC-96 or Oncophage after surgery live longer than people who may or may not have surgery but who receive conventional chemotherapy including IL-2DTIC A second goal is to determine the safety and frequency of side effects in subjects who receive therapy with HSPPC-96
Detailed Description:
Primary Objective
To determine whether subjects with stage IV melanoma randomized to HSPPC-96 have longer survival than subjects randomized to physicians choice including interleukin-2 andor dacarbazinetemozolomide andor complete tumor resection
Secondary Objective
To determine frequency of adverse events in subjects randomized to HSPPC-96
To determine whether subjects with stage IV melanoma randomized to HSPPC-96 have longer survival than subjects randomized to physicians choice including interleukin-2 andor dacarbazinetemozolomide andor complete tumor resection
Secondary Objective
To determine frequency of adverse events in subjects randomized to HSPPC-96
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