Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058279
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2003-04-07
Brief Title:
Monoclonal Antibody Therapy and Interleukin-2 in Treating Patients With Metastatic Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
MDX-CTLA4 Combined With IL-2 for Patients With Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2006-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 Interleukin-2 may stimulate a persons white blood cells to kill tumor cells Combining monoclonal antibody therapy with interleukin-2 may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of combining monoclonal antibody therapy with interleukin-2 in treating patients who have metastatic melanoma
PURPOSE Phase III trial to study the effectiveness of combining monoclonal antibody therapy with interleukin-2 in treating patients who have metastatic melanoma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose MTD of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody MDX-CTLA4 in combination with high-dose interleukin-2 IL-2 in patients with metastatic melanoma Phase I is closed to accrual as of 4132004
Determine the activity of MDX-CTLA4 administered at the MTD with high-dose IL-2 in these patients
Determine whether the administration of IL-2 alters the pharmacokinetics of MDX-CTLA4 in these patients
Determine the safety and adverse event profile of this regimen in these patients
OUTLINE This is an open-label dose-escalation study of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody MDX-CTLA4
Phase I Patients receive MDX-CTLA4 IV on days 0 21 and 42 Patients also receive high-dose interleukin-2 IL-2 IV over 15 minutes every 8 hours for up to 15 doses beginning on days 22 and 43 Treatment repeats every 63 days for up to 3 courses in the absence of disease progression or unacceptable toxicity Patients with an ongoing partial response and no greater than grade 1 toxicity may receive additional courses of therapy Patients who require discontinuation of MDX-CTLA4 due to toxicity may continue receiving IL-2 at the discretion of the investigator
Cohorts of 3-6 patients receive escalating doses of MDX-CTLA4 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 Phase I is closed to accrual as of 4132004
Phase II Patients receive treatment as in phase I at the MTD of MDX-CTLA4 Patients who achieve a partial or complete response and later develop recurrent or progressive disease may be retreated at the same dose
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 3-51 patients 3-18 for phase I and 19-33 for phase II will be accrued for this study within 1 year Phase I is closed to accrual as of 4132004
Determine the maximum tolerated dose MTD of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody MDX-CTLA4 in combination with high-dose interleukin-2 IL-2 in patients with metastatic melanoma Phase I is closed to accrual as of 4132004
Determine the activity of MDX-CTLA4 administered at the MTD with high-dose IL-2 in these patients
Determine whether the administration of IL-2 alters the pharmacokinetics of MDX-CTLA4 in these patients
Determine the safety and adverse event profile of this regimen in these patients
OUTLINE This is an open-label dose-escalation study of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody MDX-CTLA4
Phase I Patients receive MDX-CTLA4 IV on days 0 21 and 42 Patients also receive high-dose interleukin-2 IL-2 IV over 15 minutes every 8 hours for up to 15 doses beginning on days 22 and 43 Treatment repeats every 63 days for up to 3 courses in the absence of disease progression or unacceptable toxicity Patients with an ongoing partial response and no greater than grade 1 toxicity may receive additional courses of therapy Patients who require discontinuation of MDX-CTLA4 due to toxicity may continue receiving IL-2 at the discretion of the investigator
Cohorts of 3-6 patients receive escalating doses of MDX-CTLA4 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 Phase I is closed to accrual as of 4132004
Phase II Patients receive treatment as in phase I at the MTD of MDX-CTLA4 Patients who achieve a partial or complete response and later develop recurrent or progressive disease may be retreated at the same dose
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 3-51 patients 3-18 for phase I and 19-33 for phase II will be accrued for this study within 1 year Phase I is closed to accrual as of 4132004
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-03-C-0109 | None | None | None |