Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109863
Status:
COMPLETED
Last Update Posted:
2019-11-19
First Post:
2005-05-03
Brief Title:
Hu1418-Interleukin-2 Fusion Protein in Treating Patients With Advanced Melanoma
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Phase II Trial of Hu1418-IL2 EMD 273063 in Subjects With Advanced Melanoma
Status:
COMPLETED
Status Verified Date:
2015-02
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 hu1418-interleukin-2 fusion protein may stimulate the immune system in different ways and stop tumor cells from growing
PURPOSE This phase II trial is studying how well hu1418-interleukin-2 fusion protein works in treating patients with advanced melanoma
PURPOSE This phase II trial is studying how well hu1418-interleukin-2 fusion protein works in treating patients with advanced melanoma
Detailed Description:
OBJECTIVES
Primary
Determine the clinical antitumor activity of hu1418-interleukin-2 fusion protein in patients with advanced melanoma
Determine the duration of response in patients treated with this drug
Secondary
Determine the adverse events in patients treated with this drug
Determine the in vivo immunologic activation in patients treated with this drug
Determine the induction of anti-hu1418 and anti-interleukin-2 antibodies in patients treated with this drug
Determine tumor antigen recognition by this drug in select patients with cutaneous metastatic tumors as measured by binding of the drug to the cutaneous metastatic tumor and microscopic changes including immune cell density and phenotype of the tumor tissue
OUTLINE Patients receive hu1418-interleukin-2 fusion protein IV over 4 hours on days 1-3 Treatment repeats every 28 days for 2 courses in the absence of symptomatic disease progression or unacceptable toxicity Patients then undergo disease reassessment Patients with an objective partial or complete clinical response or stable disease receive 2 additional courses of treatment
PROJECTED ACCRUAL A total of 14-30 patients will be accrued for this study within 7-15 months
Primary
Determine the clinical antitumor activity of hu1418-interleukin-2 fusion protein in patients with advanced melanoma
Determine the duration of response in patients treated with this drug
Secondary
Determine the adverse events in patients treated with this drug
Determine the in vivo immunologic activation in patients treated with this drug
Determine the induction of anti-hu1418 and anti-interleukin-2 antibodies in patients treated with this drug
Determine tumor antigen recognition by this drug in select patients with cutaneous metastatic tumors as measured by binding of the drug to the cutaneous metastatic tumor and microscopic changes including immune cell density and phenotype of the tumor tissue
OUTLINE Patients receive hu1418-interleukin-2 fusion protein IV over 4 hours on days 1-3 Treatment repeats every 28 days for 2 courses in the absence of symptomatic disease progression or unacceptable toxicity Patients then undergo disease reassessment Patients with an objective partial or complete clinical response or stable disease receive 2 additional courses of treatment
PROJECTED ACCRUAL A total of 14-30 patients will be accrued for this study within 7-15 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 |
|---|---|---|---|
| P30CA014520 | NIH | None | None |
| CO04601 | OTHER | None | None |
| NCI-6304 | None | None | None |
| H-2004-0396 | OTHER | None | None |
| NCI-2009-00051 | REGISTRY | None | None |
| A533300 | OTHER | None | None |
| R01CA032685 | NIH | None | None |
| SMPHHUMAN ONCOLOGYHUMAN ONCO | OTHER | UW Madison | httpsreporternihgovquickSearchR01CA032685 |