Ignite Creation Date:
2024-05-06 @ 8:39 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02796352
Status:
TERMINATED
Last Update Posted:
2018-04-20
First Post:
2016-06-06
Brief Title:
A Phase II Study of High Dose Bolus IL2 in Patients With Inoperable Stage III or Stage IV Melanoma Who Have Failed Prior Anti-PD1 Immunotherapy Efficacy and Biomarker Study
Sponsor:
Ahmad Tarhini
Organization:
University of Pittsburgh
Study Overview
Official Title:
A Phase II Study of High Dose Bolus IL2 in Patients With Inoperable Stage III or Stage IV Melanoma Who Have Failed Prior Anti-PD1 Immunotherapy Efficacy and Biomarker Study
Status:
TERMINATED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is for patients with advanced stage III or stage IV melanoma not adequately treated by surgery who have progressed after treatment with nivolumab or pembrolizumab The purpose of this study is to see if giving high dose interleukin-2 IL-2 after progression on nivolumab or pembrolizumab is effective in treating metastatic melanoma This study is also being done to look at the severity of side effects of IL-2 in patients
IL-2 is approved by the US Food and Drug Administration FDA for the treatment of advanced melanoma
IL-2 is approved by the US Food and Drug Administration FDA for the treatment of advanced melanoma
Detailed Description:
This is a phase II study of high dose bolus interleukin-2 HD IL2 in patients with advanced inoperable stage III or stage IV melanoma who have prior anti-PD1 immunotherapy
Each course consists of 2 cycles of HD IL2 as follows high-dose IL2 at 600000 IUkg is given intravenously IV every 8 hours for up to 14 doses one cycle followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses second cycle
The planned treatment consists of 3 courses 6 cycles of HD IL-2 Response assessment will occur at the end of each course of therapy and patients without evidence of disease progression Response Evaluation Criteria in Solid Tumors RECIST version 11 or limiting toxicities will be offered additional courses of treatment of HD IL2 for a maximum of 3 courses
Each course consists of 2 cycles of HD IL2 as follows high-dose IL2 at 600000 IUkg is given intravenously IV every 8 hours for up to 14 doses one cycle followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses second cycle
The planned treatment consists of 3 courses 6 cycles of HD IL-2 Response assessment will occur at the end of each course of therapy and patients without evidence of disease progression Response Evaluation Criteria in Solid Tumors RECIST version 11 or limiting toxicities will be offered additional courses of treatment of HD IL2 for a maximum of 3 courses
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