- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01672450
A Study of Intratumoral Injection of Interleukin-2 and Ipilimumab in Patients With Unresectable Stages III-IV Melanoma
July 7, 2015 updated by: University of Utah
A Phase I Study of Intratumoral Injection of Interleukin-2 and Ipilimumab in Patients With Unresectable Stages III-IV Melanoma
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Utah
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Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: All patients
All participants in this study will receive the same treatment.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Adverse Events per patient
Time Frame: 24 months
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To assess safety of interleukin-2 and Ipilimumab combination and to select the recommended dose regimen for future phase II studies
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24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Starting and Ending measurements of treated lesions
Time Frame: 24 months
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Clinical response rate of treated lesions
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24 months
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Starting and ending measurement of untreated lesions
Time Frame: 24 months
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Clinical response rate of untreated lesions
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24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hung Khong, MD, Huntsman Cancer Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
August 21, 2012
First Submitted That Met QC Criteria
August 23, 2012
First Posted (Estimate)
August 24, 2012
Study Record Updates
Last Update Posted (Estimate)
July 8, 2015
Last Update Submitted That Met QC Criteria
July 7, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Ipilimumab
- Interleukin-2
Other Study ID Numbers
- HCI56809
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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