Status:
COMPLETED
Hu14.18-Interleukin-2 Fusion Protein in Treating Patients With Advanced Melanoma
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 stu...
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 w...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- 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
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-1
- Life expectancy
- Not specified
- Hematopoietic
- WBC ≥ 3,500/mm\^3 OR
- Granulocyte count ≥ 2,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 10.0 g/dL
- Hepatic
- AST and ALT \< 2 times normal
- Bilirubin \< 2.0 mg/dL
- Hepatitis B surface antigen negative
- No clinical evidence of hepatitis
- Renal
- Creatinine \< 2.0 mg/dL OR
- Creatinine clearance ≥ 60 mL/min
- Cardiovascular
- 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
- 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
- Immunologic
- HIV negative
- No known hypersensitivity to the study drug, Tween-80®, or human immunoglobulin
- No uncontrolled active infection
- Neurologic
- No seizure disorder
- No objective peripheral neuropathy ≥ grade 2
- No clinically significant neurologic deficit
- Other
- 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
- PRIOR CONCURRENT THERAPY:
- 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
- Chemotherapy
- 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
- Radiotherapy
- 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
- Surgery
- More than 3 weeks since prior major surgery
- No prior organ allografts
- Other
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00109863
Start Date
May 1 2005
End Date
February 1 2014
Last Update
November 19 2019
Active Locations (1)
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1
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164