Interleukin-2 Combined With Monoclonal Antibody Therapy in Treating Patients With Kidney, Bladder, or Lung Cancer That Has Not Responded to Previous Treatment

This study has been completed.
Sponsor:
Collaborators:
Memorial Sloan-Kettering Cancer Center
Information provided by:
EMD Serono
ClinicalTrials.gov Identifier:
NCT00016237
First received: May 6, 2001
Last updated: October 22, 2013
Last verified: June 2002

May 6, 2001
October 22, 2013
December 2000
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Complete list of historical versions of study NCT00016237 on ClinicalTrials.gov Archive Site
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Interleukin-2 Combined With Monoclonal Antibody Therapy in Treating Patients With Kidney, Bladder, or Lung Cancer That Has Not Responded to Previous Treatment
Phase I Dose-Escalation Study of the Pharmacokinetic, Safety, Tolerability, and Biologic Activity of huKS-IL-2 Administered Daily as a 1-Hour Intravenous Infusion for Five Consecutive Days for Treatment of Refractory Epithelial Cancer

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Interleukin-2 combined with a monoclonal antibody may be an effective treatment for kidney, bladder, or lung cancer.

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.

OBJECTIVES: I. Determine the maximum tolerated dose of KSA-interleukin-2 in patients with refractory epithelial carcinoma. II. Characterize the pharmacokinetics of this drug in these patients. III. Assess the overall toxicity and safety of this drug in these patients. IV. Determine the rate of objective response in patients treated with this drug.

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.

Interventional
Phase 1
Primary Purpose: Treatment
  • Bladder Cancer
  • Kidney Cancer
  • Lung Cancer
Biological: tucotuzumab celmoleukin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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DISEASE CHARACTERISTICS: Histologically confirmed epithelial carcinoma of 1 of the following: Renal cell carcinoma Bladder carcinoma Lung carcinoma Refractory disease or with no anticipated benefit from conventional treatment No brain metastases

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00016237
CDR0000068612, MSKCC-00141, EMD-EMR-62-206-003, NCI-G01-1944
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EMD Serono
  • National Cancer Institute (NCI)
  • Memorial Sloan-Kettering Cancer Center
Study Chair: Robert J. Motzer, MD Memorial Sloan-Kettering Cancer Center
EMD Serono
June 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP