Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090896
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2004-09-07
Brief Title:
CP-675206 CTLA4-Blocking Monoclonal Antibody Combined With Dendritic Cell Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed With Surgery
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Phase I Open Label Study To Evaluate The Safety And Immune Function Effects Of CP-675206 In Combination With MART-1 Peptide-Pulsed Dendritic Cells In Patients With Advanced Melanoma
Status:
COMPLETED
Status Verified Date:
2012-08
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 Biological therapies such as CP-675206 work in different ways to stimulate the immune system and stop tumor cells from growing Vaccines may make the body build an immune response to kill tumor cells Combining CP-675206 with vaccine therapy may cause a stronger immune response and kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of CP-675206 when given with vaccine therapy in treating patients with stage III or stage IV melanoma that cannot be removed with surgery
PURPOSE This phase I trial is studying the side effects and best dose of CP-675206 when given with vaccine therapy in treating patients with stage III or stage IV melanoma that cannot be removed with surgery
Detailed Description:
OBJECTIVES
Primary
Determine the safety and maximum tolerated dose of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody CTLA4-blocking monoclonal antibody CP-675206 administered with autologous dendritic cells pulsed with MART-1 antigen in patients with unresectable stage III or stage IV melanoma
Determine the biological activity and immune effects of this regimen in these patients
Secondary
Correlate CTLA4 genotype with safety of this regimen andor immune response in these patients
Determine preliminarily the efficacy of this regimen in terms of clinical benefit rate in these patients
OUTLINE This is an open-label dose-escalation study of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody CTLA4-blocking monoclonal antibody CP-675206
Patients receive CP-675206 IV on days 0 28 60 and 90 and autologous dendritic cells pulsed with MART-1 antigen intradermally on days 0 14 and 28 After day 120 patients with stable or responding disease may receive additional doses of CP-675206 monthly in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of CP-675206 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 3-21 patients will be accrued for this study within 3-10 months
Primary
Determine the safety and maximum tolerated dose of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody CTLA4-blocking monoclonal antibody CP-675206 administered with autologous dendritic cells pulsed with MART-1 antigen in patients with unresectable stage III or stage IV melanoma
Determine the biological activity and immune effects of this regimen in these patients
Secondary
Correlate CTLA4 genotype with safety of this regimen andor immune response in these patients
Determine preliminarily the efficacy of this regimen in terms of clinical benefit rate in these patients
OUTLINE This is an open-label dose-escalation study of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody CTLA4-blocking monoclonal antibody CP-675206
Patients receive CP-675206 IV on days 0 28 60 and 90 and autologous dendritic cells pulsed with MART-1 antigen intradermally on days 0 14 and 28 After day 120 patients with stable or responding disease may receive additional doses of CP-675206 monthly in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of CP-675206 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 3-21 patients will be accrued for this study within 3-10 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 |
|---|---|---|---|
| UCLA-0312023 | None | None | None |
| PFIZER-NRA3670003 | None | None | None |