Ignite Creation Date:
2024-05-06 @ 2:13 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01995344
Status:
TERMINATED
Last Update Posted:
2023-04-20
First Post:
2013-11-21
Brief Title:
TIL Therapy in Metastatic Melanoma and IL2 Dose Assessment
Sponsor:
The Christie NHS Foundation Trust
Organization:
The Christie NHS Foundation Trust
Study Overview
Official Title:
A Randomised Phase II Study in Metastatic Melanoma to Evaluate the Efficacy of Adoptive Cellular Therapy With Tumour Infiltrating Lymphocytes TIL and Assessment of High Versus Low Dose Interleukin-2
Status:
TERMINATED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawal of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
METILDA
Brief Summary:
This is a two arm open-labelled phase II randomised trial of Tumour Infiltrating Lymphocytes TIL in metastatic melanoma patients given with preconditioning chemotherapy and Interleukin-2 IL2 Eligible patients will undergo surgical tumour excision from which TIL will be derived cultured and expanded Patients will receive preconditioning chemotherapy with cyclophosphamide 60mgkg day -7 and day -6 followed by fludarabine 25mgm2 day -5 to day -1 The autologous TILs will be re-infused on day 0 and the patients will receive up to 12 doses of intravenous High Dose Interleukin-2 HD-IL2 or Low Dose Interleukin-2 LD-IL2 depending on the randomised arm
The primary objectives are response rate assessed and compared by CT scans carried out at week 6 week 12 and at 12 weekly intervals thereafter and the evaluation of feasibility and tolerability of TIL therapy with HD-IL2 versus LD-IL2
The primary objectives are response rate assessed and compared by CT scans carried out at week 6 week 12 and at 12 weekly intervals thereafter and the evaluation of feasibility and tolerability of TIL therapy with HD-IL2 versus LD-IL2
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2013-001071-20 | EUDRACT_NUMBER | None | None |