Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003224
Status:
COMPLETED
Last Update Posted:
2014-11-20
First Post:
1999-11-01
Brief Title:
Vaccine Therapy in Treating Patients With Metastatic Melanoma
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Phase I Protocol for the Evaluation of the Safety and Immunogenicity of Vaccination With a Synthetic Melanoma Peptide in Patients With High Risk Melanoma
Status:
COMPLETED
Status Verified Date:
2014-11
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 Vaccines made from peptide 946 may make the body build an immune response to kill tumor cells Combining these vaccines with proteins from the tetanus vaccine andor with either QS21 or Montanide ISA-51 may be an effective treatment for metastatic melanoma
PURPOSE Randomized phase I trial to study the effectiveness of vaccines made from peptide 946 with or without tetanus peptide QS21 or Montanide ISA-51 in treating patients with metastatic melanoma that cannot be surgically removed or with melanoma that is likely to recur
PURPOSE Randomized phase I trial to study the effectiveness of vaccines made from peptide 946 with or without tetanus peptide QS21 or Montanide ISA-51 in treating patients with metastatic melanoma that cannot be surgically removed or with melanoma that is likely to recur
Detailed Description:
OBJECTIVES
I Determine the safety of peptide 946 melanoma vaccine peptide 946 peptide 946 combined with tetanus peptide melanoma vaccine or peptide 946-tetanus peptide conjugate in patients with high risk melanoma
II Determine the immunogenicity of peptide 946 melanoma vaccine peptide 946 peptide 946 combined with tetanus peptide melanoma vaccine or peptide 946-tetanus peptide conjugate in patients with high risk melanoma
OUTLINE This is a randomized open-label study Patients are randomized to 1 of 6 treatment arms Arm I Patients receive peptide 946 melanoma vaccine peptide 946 emulsified with QS21 subcutaneously SQ Arm II Patients receive peptide 946 emulsified with Montanide ISA-51 ISA-51 SQ Arm III Patients receive peptide 946 combined with tetanus peptide melanoma vaccine tetanus peptide emulsified with QS21 SQ Arm IV Patients receive peptide 946 combined with tetanus peptide emulsified with ISA-51 SQ Arm V Patients receive peptide 946-tetanus peptide conjugate emulsified with QS21 SQ Arm VI Patients receive peptide 946-tetanus peptide conjugate emulsified with ISA-51 SQ Initially 4 patients are randomized to Arm I and 4 patients are randomized to Arm II If no dose limiting toxicities are observed in these patients then additional patients are randomized to arms III-VI Patients in each arm receive vaccine on day 0 and at months 1 2 3 6 9 and 12 Patients are followed at 6 and 12 months
PROJECTED ACCRUAL A maximum of 36 patients will be accrued for this study
I Determine the safety of peptide 946 melanoma vaccine peptide 946 peptide 946 combined with tetanus peptide melanoma vaccine or peptide 946-tetanus peptide conjugate in patients with high risk melanoma
II Determine the immunogenicity of peptide 946 melanoma vaccine peptide 946 peptide 946 combined with tetanus peptide melanoma vaccine or peptide 946-tetanus peptide conjugate in patients with high risk melanoma
OUTLINE This is a randomized open-label study Patients are randomized to 1 of 6 treatment arms Arm I Patients receive peptide 946 melanoma vaccine peptide 946 emulsified with QS21 subcutaneously SQ Arm II Patients receive peptide 946 emulsified with Montanide ISA-51 ISA-51 SQ Arm III Patients receive peptide 946 combined with tetanus peptide melanoma vaccine tetanus peptide emulsified with QS21 SQ Arm IV Patients receive peptide 946 combined with tetanus peptide emulsified with ISA-51 SQ Arm V Patients receive peptide 946-tetanus peptide conjugate emulsified with QS21 SQ Arm VI Patients receive peptide 946-tetanus peptide conjugate emulsified with ISA-51 SQ Initially 4 patients are randomized to Arm I and 4 patients are randomized to Arm II If no dose limiting toxicities are observed in these patients then additional patients are randomized to arms III-VI Patients in each arm receive vaccine on day 0 and at months 1 2 3 6 9 and 12 Patients are followed at 6 and 12 months
PROJECTED ACCRUAL A maximum of 36 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-H98-0010 | None | None | None |