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Protocol No. 2012CG003 Principal Investigator Miller, Jeffrey
Phase Phase I
Age Group Adult Scope National
Secondary Protocol No. CITN 11-02
Title CITN 11-02: A phase 1 study of recombinant human IL15 (rhIL15) in adults with advanced solid tumors
Objective To determine the maximum tolerated dose (MTD) of recombinant human IL15 (rhIL15) administered subcutaneous.
Treatment The dosing of rhIL15 will be given on a daily basis beginning on Monday and ending with the last dose of the week given on Friday, for two weeks. Saturday and Sunday will be rest days with no rhIL15 administered. Dosing must begin on a Monday and end on Friday.
Description This trial is a phase I, open-label, non-randomized, dose-escalation study of NCI rhIL15 in patients with advanced solid tumors in melanoma, renal cell, non-small cell lung and head and neck carcinoma. Patients will receive daily subcutaneous injection of rhIL15, five doses per week for two weeks (10 total doses) followed by 2 weeks observation. Then the cycle is repeated.
Key Eligibility Confirmed malignancy for which standard curative or palliative measures do not exist or are no longer effective in the following disease groups: melanoma, renal cell, non-small cell lung and head and neck cancer.
Applicable Disease Sites Head and Neck
Kidney
Lung
Skin
Drugs Involved IL-15
Status Open
Participating Institutions Masonic Cancer Center
Detailed Eligibility Must be at least 18 years of age and have normal organ and marrow function. Anyone with central nervous system disease is not eligible. Women who are pregnant are not eligible. Anyone with a significant active infection, who has a history of any hematopoietic malignancy, has a history of severe asthma or pulmonary disease is not eligible for this study. A signed informed consent and HIPAA authorization are required.
Treatment Type Treatment
Contact Dixie Lewis Phone:612-624-4601
Email:lewis029@umn.edu
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