A Study of Intratumoral Injection of Interleukin-2 and Ipilimumab in Patients With Unresectable Stages III-IV Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01672450
Recruitment Status : Completed
First Posted : August 24, 2012
Last Update Posted : July 8, 2015
Information provided by (Responsible Party):
University of Utah

Brief Summary:
This is a single center, open phase I dose escalation study. This study will assess the highest tolerable intratumoral dose of ipilimumab (Yervoy) in combination with IL-2 (Proleukin) in patients with unresectable stages III-IV melanoma with accessible cutaneous, subcutaneous, and/or nodal lesions. The objective is to primarily assess the safety of the drug combination, and to secondarily obtain preliminary data on the clinical efficacy of the combination.

Condition or disease Intervention/treatment Phase
Melanoma Drug: Intratumoral Ipilimumab and Interleukin-2 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Intratumoral Injection of Interleukin-2 and Ipilimumab in Patients With Unresectable Stages III-IV Melanoma
Study Start Date : September 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Ipilimumab

Arm Intervention/treatment
Experimental: All patients
All participants in this study will receive the same treatment.
Drug: Intratumoral Ipilimumab and Interleukin-2
Only 1 lesion, 0.5 -2 cm, will be treated. Interleukin-2, 3 mIU IT TIW x 2 weeks (days 1, 3 and 5), then BIW x 6 weeks (days 1 and 4). Escalating doses of Ipilimumab (0.1, 0.25, 0.5, 1, 2, mg) IT weekly x 8 weeks

Primary Outcome Measures :
  1. Number of Adverse Events per patient [ Time Frame: 24 months ]
    To assess safety of interleukin-2 and Ipilimumab combination and to select the recommended dose regimen for future phase II studies

Secondary Outcome Measures :
  1. Starting and Ending measurements of treated lesions [ Time Frame: 24 months ]
    Clinical response rate of treated lesions

  2. Starting and ending measurement of untreated lesions [ Time Frame: 24 months ]
    Clinical response rate of untreated lesions

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

- Histological diagnosis of melanoma, unresectable stages III-IV with accessible cutaneous, subcutaneous, and/or nodal lesions , according to the AJCC Staging Manual, 7th Edition, 2011.

Note: Patients who are considered to have resectable disease but decline resection are eligible.

  • 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 transfused)
  • 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.

Exclusion Criteria:

  • 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 participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01672450

United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Principal Investigator: Hung Khong, MD Huntsman Cancer Institute

Responsible Party: University of Utah Identifier: NCT01672450     History of Changes
Other Study ID Numbers: HCI56809
First Posted: August 24, 2012    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: July 2015

Keywords provided by University of Utah:
Histologically or cytologically proven melanoma; Stages III-IV; accessible cutaneous, subcutaneous, and/or nodal lesions; ECOG performance status 0 to 2

Additional relevant MeSH terms:
Nevi and Melanomas
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents