Ignite Creation Date:
2024-05-05 @ 11:05 PM
Last Modification Date:
2024-10-26 @ 10:28 AM
Study NCT ID:
NCT01253096
Status:
COMPLETED
Last Update Posted:
2014-11-20
First Post:
2010-12-02
Brief Title:
Intratumoral Application of L19IL2 in Patients With Malignant Melanoma
Sponsor:
Philogen SpA
Organization:
Philogen SpA
Study Overview
Official Title:
A Phase II Study of Intratumoral Application of L19IL2 in Patients With Stage IIIIV Melanoma
Status:
COMPLETED
Status Verified Date:
2014-11
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:
Phase II non-randomized multicenter prospective study designed to test the efficacy and safety of intratumorally administered L19IL2 in patients suffering from metastatic melanoma
Detailed Description:
Phase II non-randomized multicenter prospective study designed to test the efficacy and safety of intratumorally administered L19IL2 L19IL2 binds with high affinity to the EDB domain of Fibronectin a marker of angiogenesis which is strongly upregulated in malignant melanoma lesions This binding leads to an increased residence time of the protein at the site of disease The biologic effect of the IL2 moiety is identical to the one of free IL-2
The study treatment is up to 20 MioIU L19IL2 per week in patients suffering from histopathologically-proven malignant melanoma with presence of injectable soft-tissue metastases either in clinical stage III or stage IV M1a without visceral metastases The duration of treatment could be up to 20 weeks After the end of study visit follow-up is performed every 6 weeks until 12 months from enrollment of each patient
Tumor assessment will be performed within 2 weeks before start of treatment and at week 12 using immune-related response criteria and RECIST 11 To assure that patients do not develop visceral metastases under treatment an additional tumor assessment will be performed already at week 6 after start of therapy Assessments at week 24 and 36 will be performed according to RECIST vs 11 criteria only
Treatment emergent adverse events will be summarized by Common Toxicity Criteria version 402 CTCAE and worst grade for all treated patients Laboratory values and change in vital signs will be summarized
The study treatment is up to 20 MioIU L19IL2 per week in patients suffering from histopathologically-proven malignant melanoma with presence of injectable soft-tissue metastases either in clinical stage III or stage IV M1a without visceral metastases The duration of treatment could be up to 20 weeks After the end of study visit follow-up is performed every 6 weeks until 12 months from enrollment of each patient
Tumor assessment will be performed within 2 weeks before start of treatment and at week 12 using immune-related response criteria and RECIST 11 To assure that patients do not develop visceral metastases under treatment an additional tumor assessment will be performed already at week 6 after start of therapy Assessments at week 24 and 36 will be performed according to RECIST vs 11 criteria only
Treatment emergent adverse events will be summarized by Common Toxicity Criteria version 402 CTCAE and worst grade for all treated patients Laboratory values and change in vital signs will be summarized
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