Recombinant Interleukin-15 in Treating Patients With Advanced Melanoma, Kidney Cancer, Non-small Cell Lung Cancer, or Squamous Cell Head and Neck Cancer

Completed · Phase 1

Conditions studied: Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Carcinoma, Recurrent Non-Small Cell Lung Carcinoma, Recurrent Renal Cell Carcinoma, Recurrent Skin Carcinoma, Stage III Renal Cell Cancer, Stage IIIA Cutaneous Melanoma AJCC v7, Stage IIIA Non-Small Cell Lung Cancer AJCC v7, Stage IIIB Cutaneous Melanoma AJCC v7, Stage IIIB Non-Small Cell Lung Cancer AJCC v7, Stage IIIC Cutaneous Melanoma AJCC v7, Stage IV Cutaneous Melanoma AJCC v6 and v7, Stage IV Non-Small Cell Lung Cancer AJCC v7, Stage IV Renal Cell Cancer

In brief

This phase I trial studies the side effects and best dose of recombinant interleukin-15 in treating patients with melanoma, kidney cancer, non-small cell lung cancer, or head and neck cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Recombinant interleukin-(IL)15 is a biological product, a protein, made naturally in the body and when made in the laboratory may help stimulate the immune system in different ways and stop tumor cells from growing.

Key facts

Study ID

NCT01727076

Run by

National Cancer Institute (NCI)

People needed

20

Starts

2013-02-15

Expected to finish

2016-06-30

Last updated by the study team

2017-09-15

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histological or cytological confirmed malignancy in the following disease groups: melanoma, non-small cell lung carcinoma, renal cell carcinoma or squamous cell head and neck carcinoma, for which no standard effective or curative options are available
• Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Documented evidence of disease progression during 6 month period prior to the time of enrollment
• Prior therapy requirements:
• At least >= 1 prior completed chemotherapy regimen including chemotherapy, biologic, immunologic or targeted therapy
• At least 4 weeks from last dose of prior chemotherapy with resolution of the acute toxic effects of the therapy
• At least 2 weeks from completion of prior radiation therapy
• At least 4 weeks from last dose of prior investigational therapy
• Not receiving any current anti-cancer therapy
• At least 4 weeks from last dose of interferon or IL-2 therapy
• At least 8 weeks from completion of antibody therapy with anti-checkpoint antibodies, such as anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) and anti-programmed cell death 1 (PD1)
• At least 4 weeks from last dose of prior other biologic agents
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (Karnofsky > 70%)
• Absolute lymphocytes > 500/mcL
• Absolute neutrophil count > 1,000/mcL
• Platelets > 100,000/mcL
• Total bilirubin within normal institutional limits
• Prothrombin time (PT)/partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN)
• Hemoglobin (Hgb) > 9 g/dL
• Alkaline phosphatase =< 2.5 x ULN
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2 x institutional upper limit of normal
• Serum creatinine < 1.5 x ULN or creatinine clearance > 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
• No known central nervous system (CNS) metastases or neurological symptoms possibly related to active CNS metastasis
• Females of childbearing potential must have a negative pregnancy test within 48 hours prior to initiation of protocol therapy; NOTE: subjects are considered not of child bearing potential if they are surgically sterile, they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy or they are postmenopausal; menopause is the age associated with complete cessation of menstrual cycles, menses, and implies the loss of reproductive potential; by a practical definition, it assumes menopause after 1 year without menses with an appropriate clinical profile at the appropriate age; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time the consent is signed and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; women of child-bearing potential and men treated or enrolled on this protocol must also agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) 4 months after completion of rhIL15
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if…

• Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C), or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• Class II or greater congestive heart failure as described in the New York Heart Association Functional Classification criteria
• Patients with thyroid disease should be excluded unless their T4 is normal or they are on replacement therapy
• Patients with primary brain cancer or known brain metastases should be excluded from this clinical trial
• Patients who have received prior anti-CTLA4 or anti-PD1 therapy less than 8 weeks prior to enrollment
• Patients who have received prior biologic agents less than 4 weeks prior to enrollment
• Patients who have received prior interferon or IL-2 therapy less than 4 weeks prior to enrollment
• ECOG score greater than 1 (Karnofsky < 70%)
• HIV-positive patients
• Positive hepatitis C serology
• Patients who are receiving any other investigational agents
• Inability to home monitor blood pressure
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Where it is running

• Stanford Cancer Institute Palo Alto — Palo Alto, California, United States
• National Institutes of Health Clinical Center — Bethesda, Maryland, United States
• University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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