Hu14.18-Interleukin-2 Fusion Protein in Treating Patients With Advanced Melanoma

Phase 2

Completed

• Conditions: Melanoma (Skin)

• Registration Number: NCT00109863
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

RATIONALE: Biological therapies, such as hu14.18-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 hu14.18-interleukin-2 fusion protein works in treating patients with advanced melanoma.

Detailed Description

OBJECTIVES:

Primary

* Determine the clinical antitumor activity of hu14.18-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-hu14.18 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 hu14.18-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 Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-05-03
• Study First Submitted QC: 2005-05-03
• Study First Posted: 2005-05-04
• Primary Completion: 2007-07
• Study Completion: 2014-02
• Status Verified: 2015-02
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Objective response rate and duration of response by clinical exam and radiology studies after every 2 courses

Secondary Outcome Measures

Name	Time	Method
Immunologic activation induced by hu14.18-interleukin-2 after every 2 courses
Adverse events by clinical assessment daily during treatment and weekly after completion of study treatment
Induction of anti-idiotypic antibodies on days 1, 3, 4, and 8 of each course

Trial Locations

Locations (1)

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center; 🇺🇸 Madison, Wisconsin, United States