A Phase I Study of Intratumoral Injection of Interleukin-2 and Ipilimumab in Patients With Unresectable Stages III-IV Melanoma
- Histological diagnosis of melanoma, unresectable stages III-IV with accessible
cutaneous, subcutaneous, and/or nodal lesions , according to the AJCC Staging Manual, 7th
Note: Patients who are considered to have resectable disease but decline resection are
- At least one lesion > 0.5 cm and < 2 cm
- ECOG performance status 0, 1 or 2
- Negative pregnancy test for women of childbearing potential within 7 days of
enrollment on study.
- WBC > 2,000/mm3; ANC > 1,000/mm3; platelet > 100,000/mm3;hemoglobin > 9 gm/dL (may be
- Serum bilirubin levels <1.5 mg/dL except for patients with Gilbert's syndrome.
- Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) < 2.5 X upper
limit of normal, alkaline phosphatase < 2.5 X upper limit of normal.
- Serum creatinine levels <1.5 mg/dL
- Women of childbearing potential should be advised to avoid becoming pregnant and men
should be advised to not father a child while receiving treatment with ipilimumab or
interleukin-2. Patients should agree to use an appropriate method of birth control
while on study. Examples of adequate forms of birth control for women include oral
or implanted contraceptives, intrauterine device (IUD), diaphragm with spermicide,
cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual
partner and also based on the judgment of the investigator.
- Age > 18 years and of any gender or race.
- Able to provide informed consent and have signed an approved consent form that
conforms to federal and institutional guidelines.
- Concurrent therapy with any other non-protocol anti-cancer therapy
- Prior local therapy within 2 weeks or prior systemic therapy within 4 weeks of
starting protocol treatment
- History of any other malignancy requiring active treatment
- Pre-existing autoimmunity: History of inflammatory bowel disease; history of
symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive
sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g.,
Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g.,
Guillain-Barre Syndrome). History of vitiligo is allowed.
- Chronic use immunosuppressants or systemic corticosteroids. Note: Chronic use is
defined as requiring corticosteroids for greater than one month prior to enrollment
on study. Corticosteroid use for less than 1 month prior to enrollment is allowed,
but use must stop prior to starting study treatment.
- Clinically significant cardiovascular disease (e.g., uncontrolled hypertension [BP
>150/100], myocardial infarction or stroke within 6 months, unstable angina), New
York Heart Association (NYHA) Grade II or greater congestive heart failure, or
serious cardiac arrhythmia requiring medication
- Currently active systemic infection
- Known history of HIV infection or chronic hepatitis B or C.
- The presence of any other medical or psychiatric disorder that, in the opinion of the
treating physician, would contraindicate the use of the drugs in this protocol or
place the subject at undue risk for treatment complications
- Pregnancy or breast feeding
- A history of a severe hypersensitivity reaction to ipilimumab or interleukin-2
- Any reason why, in the opinion of the investigator, the patient should not