Yervoy With Sylatron Unresectable Stage 3 or 4 Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Sylatron; Yervoy
Intervention description: Sylatron - Once per week for 12 weeks, given as an injection under the skin.; Yervoy - Once every 3 weeks for 12 weeks (4 times total), given over a 90-minute intravenous infusion (through the vein).
Intervention MeSH terms: Peginterferon alfa-2b; Ipilimumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: unresectable; stage 3; stage 4; autoimmune; antibodies

Summary:

      The purpose of this study is to see how much of the drug Yervoy can be safely tolerated when
      it is given to people who are also receiving a drug called Sylatron. Investigators also wish
      to find out whether the addition of Yervoy increases the chance that Sylatron will cause a
      rise in the level of antibodies in the patient's blood that recognize their own tissues,
      known as "autoimmune" antibodies. Investigators also want to find out how likely it is that
      their tumor will shrink.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have cytologically or histologically-confirmed and unresectable melanoma,
             previously untreated systemically other than a BRAF inhibitor for metastatic disease,
             meeting one of the following American Joint Committee on Cancer (AJCC) staging
             criteria: AJCC Stage IV (Tany,Nany,M1); AJCC Stage IIIB/C patients with unresectable
             nodal/locoregional involvement; Patients with cutaneous, ocular or mucosal melanoma
             are eligible

          -  Must have adequate hepatic, renal and bone marrow function as defined by the following
             parameters obtained within 4 weeks prior to initiation of study treatment. Hematologic
             Criteria: white blood count (WBC) >/= 3.0 x 10^9/L, Platelet > 100 x 10^9/L,
             Hemoglobin >/= 9 g/dL or 5.6 mmol/L; Renal and Hepatic Functional Criteria: Serum
             creatinine < 2.0 mg/dL or < 140 μmol/L, serum glutamic oxaloacetic transaminase (SGOT)
             and serum glutamic pyruvic transaminase (SGPT) < 2 times upper normal limit of
             laboratory normal (ULN)

          -  Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Must give informed consent according to institutional policy

          -  Must be willing to give written informed consent and must be able to adhere to dose
             and visit schedules

          -  Female patients of childbearing potential must be using a medically accepted method of
             birth control prior to Screening and agree to continue its use during the study or be
             surgically sterilized (e.g., hysterectomy or tubal ligation). Females of childbearing
             potential should be counseled in the appropriate use of birth control while in this
             study. Females who are not currently sexually active must agree and consent to use one
             of the above-mentioned methods should they become sexually active while participating
             in the study.

          -  Female patients of childbearing potential must have a negative serum pregnancy test
             (beta-hCG) at Screening.

        Exclusion Criteria:

          -  Female patients who are pregnant, intend to become pregnant, or are nursing

          -  Previously treated with interferon alpha 2b, Sylatron or Yervoy therapy for melanoma

          -  Patients whose disease can be completely surgically resected

          -  Have not recovered from the effects of recent surgery

          -  Patients with a history of prior malignancy within the past 2 years other than
             surgically cured squamous or basal cell carcinoma of the skin, or cervical carcinoma
             in situ

          -  Have severe cardiovascular disease, i.e., arrhythmias requiring chronic treatment,
             congestive heart failure (NYHA Class III or IV) or symptomatic ischemic heart disease

          -  Patients with thyroid dysfunction not responsive to therapy

          -  Patients who, in the opinion of the investigator, have uncontrolled diabetes mellitus

          -  Suffering from an active autoimmune disease except medically controlled hypothyroidism
             and vitiligo

          -  An active and/or uncontrolled infection, including active hepatitis

          -  Have a history of seropositivity for HIV

          -  Pre-existing psychiatric condition, including but not limited to: History of severe
             depression (including Hospitalization for depression, Electroconvulsive therapy for
             depression, Depression that resulted in a prolonged absence from work and/or
             significant disruption of daily functions); Suicidal of homicidal ideation and/or
             suicidal or homicidal attempt; History of severe psychiatric disorders (e.g.,
             psychosis, post-traumatic stress disorder or mania); Past history or current use of
             lithium and/or antipsychotic drugs

          -  A clinical diagnosis of substance abuse of the one or more of the following drugs,
             within the following timeframes, (not including time spent in detoxification,
             hospitalization or incarceration): Alcohol, intravenous drug use (IVDU), inhalational,
             psychotropics, narcotics, cocaine, prescription or over-the-counter drugs: within 1
             year of the Screening visit; Receiving methadone, buprenorphine hydrochloride (HCL),
             and/or butorphanol tartrate within 1 year of Screening visit, unless participant has
             drug screen negative for other (non-narcotic) drugs documented in past year and
             repeated negative within 2 months of Screening visit; Multi-drug abuse (2 or more
             substances in 17a and 17b) within 3 years of Screening visit; If the patient's
             historic marijuana use is deemed excessive by the principal investigator (PI), or
             medically qualified individual or is interfering with the patient's life, then the
             patient is not eligible and should not be screened. If patient's marijuana use is not
             deemed excessive by PI and does not interfere with life, the patient must be
             instructed to discontinue any current use of recreational marijuana prior to entry
             into study.

          -  Patients with a medical condition requiring chronic systemic corticosteroids

          -  Known to be allergic to the drug substance or any of the excipients in the Sylatron or
             Yervoy formulation

          -  Patients who are in a situation or have any condition that, in the opinion of the
             investigator, may interfere with optimal participation in the study

          -  Have used any investigational drugs within 30 days of study entry

          -  Are participating in any other clinical treatment study