Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00108875
Status:
UNKNOWN
Last Update Posted:
2006-07-28
First Post:
2005-04-19
Brief Title:
Survivin Peptide Vaccination for Patients With Advanced Melanoma Pancreatic Colon and Cervical Cancer
Sponsor:
Julius-Maximilians University
Organization:
Julius-Maximilians University
Study Overview
Official Title:
Vaccination of Patients With Advanced Melanoma Pancreatic Colon and Cervical Cancer With HLA-A1 -A2 and -B35 Restricted Survivin Peptides
Status:
UNKNOWN
Status Verified Date:
2005-06
Last Known Status:
RECRUITING
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:
This study evaluates the safety the immunological response and the clinical outcome of a vaccination with survivin peptides for patients with advanced melanoma pancreatic colon and cervical carcinoma
Detailed Description:
As prognosis of advanced melanoma pancreatic colon and cervical cancer remains gloomy new therapeutic modalities have to be developed to improve the patients clinical outcome Immunotherapy which targets tumor associated antigens of tumor cells or tumor stroma is currently an intensively investigated novel therapeutic option As survivin is expressed both by neoplastic cells as well as by endothelial cells of the tumor vasculature this antigen is an intriguing target molecule Spontaneous cytotoxic T-cell responses against different survivin epitopes in cancer patients underline the relevance of survivin-directed immunological trials This study is comprised of a peptide vaccine with HLA-A1 -A2 and -B35 restricted survivin epitopes in Montanide ISA-51 for patients with stage IV melanoma advanced pancreatic colon and cervical carcinoma The vaccine is applicated as a deep subcutaneous injection Vaccination is administered for the first 2 months weekly afterwards every 4 weeks Standard staging examinations are performed every three months Clinical laboratory and immunological monitoring is done every monthDiagnostic leucapheresis is performed before first vaccination and afterwards every 2 months
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 |
|---|---|---|---|
| IRB 0703 | None | None | None |
| PEI 089901 | None | None | None |