Pilot hu14.18-IL2 in Resectable Recurrent Stage III or Stage IV Melanoma

Phase 2

Completed

• Conditions: Melanoma
• Interventions: Drug: hu14.18-IL2

• Registration Number: NCT00590824
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

Evaluate the antitumor activity of hu14.18-IL2 in the minimal residual disease setting. Evaluate the time to recurrence and overall survival of patients treated with hu14.18-IL2.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-17
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2008-01-10
• Study First Posted: 2008-01-11
• Primary Completion: 2018-09-20
• Study Completion: 2018-09-20
• Results First Submitted: 2019-08-01
• Results First Submitted QC: 2019-10-03
• Results First Posted: 2019-10-22
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-13
• Last Update Posted: 2019-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	hu14.18-IL2	Hu14.18-IL2 --\>Resection--\>Hu14.18-IL2
B	hu14.18-IL2	Resection --\>Hu14.18-IL2--\>Hu14.18-IL2

Primary Outcome Measures

Name	Time	Method
Recurrence Free Survival (RFS)	up to 24 months	RFS was defined as the number of days from the day of evaluation following course 2 of immunocytokine treatment to the day the subject experienced an event of recurrence or death, whichever occurred first. Participants who did not experience an event of recurrence or death at the time of analysis were censored at the date of the last evaluation for recurrence.
Overall Survival (OS)	up to 24 months	OS was defined as the number of days from randomization to the date of the participant's death. Participants who did not experience an event of death at the time of analysis were censored at the date of the last follow-up.
Ganglioside Expressed by Tumor Cells (GD2)	up to 1 week	Histological analysis of anti-tumor activity is a primary endpoint. This is measured after surgical resection via staining to indicate GD2 expression. The GD2 results were summarized in terms of positive (GD2 expression high or low/moderate) and negative (GD2 expression undetectable).

Secondary Outcome Measures

Name	Time	Method
Anti-Idiotypic Antibodies	up to 12 weeks	Detection of anti-idiotypic will be performed on participants' serum obtained approximately 10 minutes prior to initiation of treatment, and serum samples on Days 3, 4, 8, and 29/1 of 3 cycles.
Anti-Fc-IL2 Antibodies	up to 12 weeks	Detection of anti-FcIL2 will be performed on participants' serum obtained approximately 10 minutes prior to initiation of treatment, and serum samples on Days 3, 4, 8, and 29/1, for 3 cycles
C-Reactive Protein (CRP)	up to 29 days	CRP measured at baseline, cycle 1 day 3, and cycle 2 day 1.
Lymphocyte Count	up to 29 days	Lymphocyte count measured at baseline, cycle 1 day 3, cycle 1 day 8, and cycle 2 day 1
In Vitro Soluble Interleukin-2 (IL2) Receptor Alpha Levels	up to 12 weeks	Soluble IL2 receptor α levels will be performed on participants approximately 10 minutes prior to initiation of treatment, and serum samples on Days 3, 4, 8, and 29/1.

Trial Locations

Locations (1)

University of Wisconsin Hospitals and Clinics; 🇺🇸 Madison, Wisconsin, United States