Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077532
Status:
COMPLETED
Last Update Posted:
2012-06-22
First Post:
2004-02-10
Brief Title:
Monoclonal Antibody With or Without gp100 Peptides Plus Montanide ISA-51 in Treating Patients With Stage IV Melanoma
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Study of Intra-Patient Escalating Doses of MDX-010 Given Alone or in Combination With Two gp100 Peptides Emulsified With Montanide ISA-51 in the Treatment of Patients With Stage IV Melanoma
Status:
COMPLETED
Status Verified Date:
2012-06
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:
RATIONALE Biological therapies such as MDX-010 work in different ways to stimulate the immune system and stop tumor cells from growing Vaccines made from gp100 peptides may make the body build an immune response to kill tumor cells Combining the vaccines with Montanide ISA-51 may cause a stronger immune response and kill more tumor cells It is not yet known whether monoclonal antibody therapy is more effective with or without vaccine therapy in treating advanced melanoma
PURPOSE This randomized phase II trial is studying monoclonal antibody therapy alone to see how well it works compared to monoclonal antibody therapy gp100 peptides and Montanide ISA-51 in treating patients with stage IV melanoma
PURPOSE This randomized phase II trial is studying monoclonal antibody therapy alone to see how well it works compared to monoclonal antibody therapy gp100 peptides and Montanide ISA-51 in treating patients with stage IV melanoma
Detailed Description:
OBJECTIVES
Primary
Determine the clinical response in patients with stage IV melanoma treated with escalating doses of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody MDX-010 with or without gp100 peptides emulsified in Montanide ISA-51
Secondary
Determine the safety and toxicity profile of these regimens in these patients
Determine the immunologic response in patients treated with these regimens
Determine the pharmacokinetics of these regimens in these patients
Determine in HLA-A0201-positive patients the differences in responses between patients previously vaccinated with gp100 peptides and patients not previously vaccinated
OUTLINE This is a 2-part partially randomized study
Part I closed as of 372005
HLA-A0201-negative patients Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody MDX-010 IV over 90 minutes on day 1 Treatment repeats every 3 weeks for up to 6 doses 3 courses of 3 escalating doses in the absence of disease progression or unacceptable toxicity
HLA-A0201-positive patients Patients are stratified according to prior exogenous gp100 peptide immunization yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive MDX-010 in the same manner as the HLA-A0201-negative patients
Arm II Patients receive MDX-010 as in arm I Patients also receive gp100209-217 and gp100280-288 peptides emulsified in Montanide ISA-51 subcutaneously immediately after each MDX-010 infusion
Part II
HLA-A0201-negative patients closed as of 372005 Patients receive MDX-010 as in part I Treatment repeats every 3 weeks for up to 4 doses 2 courses of 2 escalating doses beginning with a higher dose level than in part I in the absence of disease progression or unacceptable toxicity
HLA-A0201-positive patients Patients are stratified and randomized as in part I
Arm I Patients receive MDX-010 in the same manner as the HLA-A0201-negative patients
Arm II Patients receive MDX-010 as in arm I Patients also receive gp100209-217 and gp100280-288 peptides emulsified in Montanide ISA-51 subcutaneously immediately after each MDX-010 infusion
In both parts patients with stable disease or a complete response CR after completing all courses of MDX-010 may receive 1 additional course of therapy in the absence of unacceptable toxicity Patients achieving a partial response may continue to recieve treatment with MDX-010 at the same dose in the absence of unacceptable toxicity until CR or until tumor is no longer shrinking
Patients are followed at 3 weeks every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 35-179 patients up to 35 for part I closed as of 3705 and 69-141 23-47 per arm arm I closed as of 3705 for part II will be accrued for this study within 3-4 years
Primary
Determine the clinical response in patients with stage IV melanoma treated with escalating doses of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody MDX-010 with or without gp100 peptides emulsified in Montanide ISA-51
Secondary
Determine the safety and toxicity profile of these regimens in these patients
Determine the immunologic response in patients treated with these regimens
Determine the pharmacokinetics of these regimens in these patients
Determine in HLA-A0201-positive patients the differences in responses between patients previously vaccinated with gp100 peptides and patients not previously vaccinated
OUTLINE This is a 2-part partially randomized study
Part I closed as of 372005
HLA-A0201-negative patients Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody MDX-010 IV over 90 minutes on day 1 Treatment repeats every 3 weeks for up to 6 doses 3 courses of 3 escalating doses in the absence of disease progression or unacceptable toxicity
HLA-A0201-positive patients Patients are stratified according to prior exogenous gp100 peptide immunization yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive MDX-010 in the same manner as the HLA-A0201-negative patients
Arm II Patients receive MDX-010 as in arm I Patients also receive gp100209-217 and gp100280-288 peptides emulsified in Montanide ISA-51 subcutaneously immediately after each MDX-010 infusion
Part II
HLA-A0201-negative patients closed as of 372005 Patients receive MDX-010 as in part I Treatment repeats every 3 weeks for up to 4 doses 2 courses of 2 escalating doses beginning with a higher dose level than in part I in the absence of disease progression or unacceptable toxicity
HLA-A0201-positive patients Patients are stratified and randomized as in part I
Arm I Patients receive MDX-010 in the same manner as the HLA-A0201-negative patients
Arm II Patients receive MDX-010 as in arm I Patients also receive gp100209-217 and gp100280-288 peptides emulsified in Montanide ISA-51 subcutaneously immediately after each MDX-010 infusion
In both parts patients with stable disease or a complete response CR after completing all courses of MDX-010 may receive 1 additional course of therapy in the absence of unacceptable toxicity Patients achieving a partial response may continue to recieve treatment with MDX-010 at the same dose in the absence of unacceptable toxicity until CR or until tumor is no longer shrinking
Patients are followed at 3 weeks every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 35-179 patients up to 35 for part I closed as of 3705 and 69-141 23-47 per arm arm I closed as of 3705 for part II will be accrued for this study within 3-4 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-C-0083 | None | None | None |
| MDX-010-19 | None | None | None |
| NCI-6532 | None | None | None |
| CDR0000352187 | None | None | None |