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Phase II Trial of Hu14.18-IL2 (EMD 273063) in Subjects With Advanced Melanoma

Phase 2
18 Years
Open (Enrolling)
Melanoma (Skin)

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Trial Information

Phase II Trial of Hu14.18-IL2 (EMD 273063) in Subjects With Advanced Melanoma



- 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

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

Inclusion Criteria


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:


Principal Investigator

Mark R. Albertini, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison


United States: Federal Government

Study ID:




Start Date:

May 2005

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • recurrent melanoma
  • stage IV melanoma
  • Melanoma



University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792-6164