Hu14.18-Interleukin-2 Fusion Protein in Treating Patients With Advanced Melanoma
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Hu14.18-IL2 (EMD 273063) in Subjects With Advanced Melanoma|
- Objective response rate and duration of response by clinical exam and radiology studies after every 2 courses [ Designated as safety issue: No ]
- Adverse events by clinical assessment daily during treatment and weekly after completion of study treatment [ Designated as safety issue: Yes ]
- Immunologic activation induced by hu14.18-interleukin-2 after every 2 courses [ Designated as safety issue: No ]
- Induction of anti-idiotypic antibodies on days 1, 3, 4, and 8 of each course [ Designated as safety issue: No ]
|Study Start Date:||May 2005|
|Study Completion Date:||February 2014|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
Experimental: Hu14.18-IL2 Treatment
Hu14.18-IL2 will be given on days 1, 2, and 3 of each course of therapy as a 4 hour continuous IV infusion at a daily dose of 6 mg/m2. Treatment courses will be repeated every 28 days at the same dose.
|Biological: hu14.18-IL2 fusion protein|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109863
|United States, Wisconsin|
|University of Wisconsin Paul P. Carbone Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792-6164|
|Study Chair:||Mark R. Albertini, MD||University of Wisconsin, Madison|