Interleukin-2 Combined With Monoclonal Antibody Therapy in Treating Patients With Kidney, Bladder, or Lung Cancer That Has Not Responded to Previous Treatment
NCT ID: NCT00016237
Last Updated: 2013-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
2000-12-31
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of interleukin-2 combined with a monoclonal antibody in treating patients who have kidney, bladder, or lung cancer that has not responded to previous treatment.
Detailed Description
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OUTLINE: This is a dose-escalation, multicenter study. Patients receive KSA-interleukin-2 (KSA-IL-2) IV over 1 hour on days 1-5. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of KSA-IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which more than 33% of the patients experience a dose-limiting toxicity. Patients are followed at 30 days.
PROJECTED ACCRUAL: Approximately 12-24 patients will be accrued for this study within 6-12 months.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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tucotuzumab celmoleukin
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL WBC at least 3,500/mm3 OR Granulocyte count at least 2,000/mm3 Hepatic: Bilirubin no greater than 3 times upper limit of normal (ULN) AST and ALT no greater than 3 times ULN Renal: Creatinine less than 2 times ULN Cardiovascular: Normal EKG No prior myocardial infarction No arteriovenous block greater than I, complete hemiblock, hypertrophy, or relevant arrhythmia No uncontrolled hypertension (diastolic at least 100 mmHg) or hypotension (systolic no greater than 90 mmHg) No prior episodes of syncope No prior cardiac disease or significant risk factors for coronary artery disease, unless there is no evidence of myocardial ischemia on exercise thallium scan or other exam (e.g., exercise EKG or dobutamine stress echocardiography) or there is no evidence of significantly impaired left ventricular function on echocardiographic exam Normal thallium scan if patient is at least 65 years old Pulmonary: Normal chest x-ray No pulmonary congestion, pleural effusions, pulmonary fibrosis, or significant emphysema Other: No concurrent infection No clinical evidence of immunosuppression No known hypersensitivity to study drug, interleukin-2, Tween-80, or human immunoglobin No other condition that would preclude study No Addison's disease No Crohn's disease Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study Thyroid-sensitizing hormone no greater than 4.7 mU/L
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 30 days since prior biologic therapy No other concurrent immunotherapy Chemotherapy: At least 30 days since prior chemotherapy (6 weeks since mitomycin or nitrosoureas) No concurrent chemotherapy Endocrine therapy: At least 30 days since prior endocrine therapy No concurrent systemic corticosteroid therapy Radiotherapy: No prior radiotherapy to at least 25% of bone marrow At least 30 days since prior radiotherapy At least 3 months since prior radioisotope therapy (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium) No concurrent radiotherapy Surgery: At least 3 weeks since prior major surgery No prior organ transplantation Other: At least 30 days since prior investigational drug No prior therapy that would preclude study No other concurrent investigational drugs No concurrent immunosuppressive therapy
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Memorial Sloan Kettering Cancer Center
OTHER
EMD Serono
INDUSTRY
Principal Investigators
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Robert J. Motzer, MD
Role: STUDY_CHAIR
Memorial Sloan Kettering Cancer Center
Locations
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Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Countries
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Other Identifiers
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MSKCC-00141
Identifier Type: -
Identifier Source: secondary_id
EMD-EMR-62-206-003
Identifier Type: -
Identifier Source: secondary_id
NCI-G01-1944
Identifier Type: -
Identifier Source: secondary_id
CDR0000068612
Identifier Type: -
Identifier Source: org_study_id