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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00109863
Recruitment Status : Completed
First Posted : May 4, 2005
Last Update Posted : February 16, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: hu14.18-IL2 fusion protein Phase 2

Detailed Description:



  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Hu14.18-IL2 (EMD 273063) in Subjects With Advanced Melanoma
Study Start Date : May 2005
Actual Primary Completion Date : July 2007
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Objective response rate and duration of response by clinical exam and radiology studies after every 2 courses

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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed malignant melanoma

    • Advanced disease
  • Measurable disease by clinical assessment or imaging
  • No known standard curative therapy exists

    • Disease no longer controlled by surgery, chemotherapy, or radiotherapy
  • No clinically detectable pleural effusion or ascites
  • No brain metastases



  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified


  • WBC ≥ 3,500/mm^3 OR
  • Granulocyte count ≥ 2,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10.0 g/dL


  • AST and ALT < 2 times normal
  • Bilirubin < 2.0 mg/dL
  • Hepatitis B surface antigen negative
  • No clinical evidence of hepatitis


  • Creatinine < 2.0 mg/dL OR
  • Creatinine clearance ≥ 60 mL/min


  • No ischemic cardiac disease, congestive heart failure, or myocardial infarction within the past 6 months
  • No uncontrolled cardiac rhythm disturbance
  • No myocardial ischemia or heart failure by exercise radionuclide scan for patients with a history of cardiac disease, significant risk factors for coronary artery disease, or ≥ 65 years of age


  • Pulmonary function normal by exercise radionuclide scan for patients with a history of cardiac disease, significant risk factors for coronary artery disease, or ≥ 65 years of age


  • HIV negative
  • No known hypersensitivity to the study drug, Tween-80®, or human immunoglobulin
  • No uncontrolled active infection


  • No seizure disorder
  • No objective peripheral neuropathy ≥ grade 2
  • No clinically significant neurologic deficit


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Must consent to the placement of a central venous line OR demonstrate stable peripheral IV access
  • Must be willing and able to discontinue antihypertensive medications (if advised to do so) on the days of study drug infusion
  • No uncontrolled active peptic ulcer
  • No known grade 4 side effects related to prior interleukin-2
  • No diabetes mellitus that has required systemic therapy (e.g., oral hypoglycemic agents or insulin) within the past 3 months
  • No other significant illness
  • No significant psychiatric disability


Biologic therapy

  • Prior monoclonal antibodies for biologic therapy, tumor imaging, purging of autologous bone marrow/stem cells for re-infusion, or for any other reason allowed provided there is documented absence of detectable antibody to hu14.18 by serology
  • No concurrent growth factors


  • No immediate requirement for palliative chemotherapy
  • No concurrent anticancer chemotherapy

Endocrine therapy

  • More than 2 weeks since prior and no concurrent corticosteroids (e.g., dexamethasone)
  • No immediate requirement for palliative hormonal therapy


  • No immediate requirement for palliative radiotherapy

    • Concurrent palliative radiotherapy to localized painful lesions allowed provided ≥ 1 measurable or evaluable lesion is not irradiated AND the irradiated lesion is not used to assess tumor response


  • More than 3 weeks since prior major surgery
  • No prior organ allografts


  • More than 2 weeks since other prior and no concurrent immunosuppressive drugs
  • No prior standard or experimental systemic therapy for stage IV melanoma
  • No concurrent myelosuppressive antineoplastic drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00109863

United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)
Study Chair: Mark R. Albertini, MD University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison Identifier: NCT00109863     History of Changes
Other Study ID Numbers: CDR0000426431
P30CA014520 ( U.S. NIH Grant/Contract )
First Posted: May 4, 2005    Key Record Dates
Last Update Posted: February 16, 2015
Last Verified: February 2015

Keywords provided by University of Wisconsin, Madison:
recurrent melanoma
stage IV melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents