Ipilimumab Administered to Stage IIIC Stage IV Melanoma After Reg. T Cell Depletion With Denileukin Diftitox

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 2

Inclusion Criteria

Male or female patients ≥18 years of age;
Patients with histological confirmed melanoma (Stage IIIC or Stage IV, American Joint Commission on Cancer);
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2;
Life expectancy ≥3 months;
Treatment with Denileukin Diftitox within 42 days prior to first dose of Ipilimumab;
At least 1 site of radiographically measurable disease by immune-related response criteria (irRC);
Adequate hematologic, renal, and liver function as defined by laboratory values performed within 42 days prior to initiation of dosing:
- Absolute neutrophil count (ANC) ≥1.0 x 109/L;
- Platelet count ≥100 x 109/L;
- Hemoglobin ≥8 g/dL;
- Serum creatinine ≤3 x upper limit of normal (ULN)
- Total serum bilirubin ≤2 x ULN;
- Serum aspartate transaminase (AST/SGOT) or serum alanine transaminase (ALT/SGPT) ≤2x ULN, and ≤3 x ULN if liver metastases are present.
Fertile males should use an effective method of contraception during treatment and for at least 3 months after completion of treatment, as directed by their physician;
Pre-menopausal females and females <2 years after the onset of menopause should have a negative pregnancy test at Screening. Pre-menopausal females must agree to use an acceptable method of birth control from the time of the negative pregnancy test up to 90 days after the last dose of study drug. Females of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year;
Before study entry, written informed consent must be obtained from the patient prior to performing any study-related procedures.

Exclusion Criteria

Prior treatment with Ipilimumab;
Known hypersensitivity to Ipilimumab or any of its components;
Steroids within one week prior to initiation of Ipilimumab.
Pre-existing autoimmune colitis.
Patients with an allograft requiring immunosuppression;
Known positive human immunodeficiency virus (HIV)
Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives, or avoidance of pregnancy measures;
Have any other uncontrolled infection or medical condition that could interfere with the conduct of the study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ipilimumab	Ipilimumab	IV ipilimumab

Primary Outcome Measures

Name	Time	Method
Change From Baseline Using Immune-related Response Criteria (irRC)	baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks	no outcomes available, Study was Terminated due to low subject enrollment \[r/t requirement of prior treatment with denileukin diftitox\] Data was not analyzed

Secondary Outcome Measures