A Study of Intratumoral Injection of Interleukin-2 and Ipilimumab in Patients With Unresectable S… (NCT01672450) | Clinical Trial Compass
CompletedPhase 1
A Study of Intratumoral Injection of Interleukin-2 and Ipilimumab in Patients With Unresectable Stages III-IV Melanoma
United States12 participantsStarted 2012-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 info…