Vaccine Therapy With or Without Recombinant Interleukin-12 Followed by Daclizumab in Treating Patients With Metastatic Melanoma

This is an interventional treatment trial for Recurrent Melanoma Read More

Inclusion Criteria:

• Patients must have histologically confirmed melanoma with evidence of metastatic disease either by radiologic or physical examination

  • In-transit metastases are allowed
  • Biopsy should be performed to reconfirm the diagnosis in cases of doubt

• Patients must have measurable disease

  • For computed tomography (CT) imaging, this is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral CT scan
  • For cutaneous lesions, these must be measurable with a ruler and documented photographically with a ruler in place
• There are no limits on the number of prior therapies; patients must not have received a vaccine containing any of the melanoma antigen peptides, nor previously received daclizumab; at least 4 weeks must have passed since prior chemotherapy or radiation therapy (6 weeks for BCNU [carmustine] or mitomycin C)
• Life expectancy greater than or equal to 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky ≥ 80%)
• Leukocytes ≥ 3,000/mcL
• Absolute neutrophil count (ANC) ≥ 1,500/mcL
• Hemoglobin ≥ 9 g/dL
• Platelets ≥ 100,000/mcL
• Creatinine ≤ 1.5 x upper limit of normal (ULN)
• Total bilirubin ≤ 1.5 x ULN
• Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) ≤ 2 x institutional ULN
• Lactate dehydrogenase (LDH) < 1.25 x ULN
• Human leukocyte antigen (HLA) typing: patient must express HLA-A2, either by flow cytometry or by standard HLA typing
• Patient must agree to undergo biopsy of accessible tumor before and after therapy, when feasible, to study tumor cell properties and characteristics of immune cells; if a biopsy cannot be done, then a prior pathologic specimen from the patient must show tumor cells that are positive for melanosome specific antigen (HMB45) and MLANA (MelanA); the tumor must express at least 2 antigens in the vaccine for the patient to be eligible
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal, barrier method of birth control, or abstinence) prior to study entry, for the duration of treatment, and for 2 months after completion of treatment; a pregnancy test must be done and be negative for women of child-bearing potential; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Patients who have had chemotherapy, biological or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• Patients may not be receiving any other investigational agents
• Presence of untreated brain metastases; all patients must undergo brain imaging as part of the pre-study evaluation; only patients with no brain metastases, or with brain lesions successfully treated by stereotactic radiation or surgical removal without progression at 28-day follow-up and off corticosteroids for 4 weeks, will be eligible
• History of allergic reactions attributed to compounds of similar chemical or biologic composition IL-12 or other agents used in the study
• Concurrent systemic corticosteroids (except physiologic replacement doses) or other immunosuppressive drugs (eg. cyclosporin A)
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with IL-12; women of child-bearing age must be tested for urinary or serum beta-human chorionic gonadotropin (HCG)
• Patients with intrinsic immunosuppression, including seropositivity for human immunodeficiency virus (HIV) antibody; patients should be tested for HIV; HIV-positive patients are ineligible
• Psychiatric illness that may make compliance to the clinical protocol unmanageable or may compromise the ability of the patient to give informed consent; patients with clinical evidence of dementia should have a competent designee participate in decision making
• Serious concurrent infection, including active tuberculosis, hepatitis B, or hepatitis C; patients should be tested for hepatitis B surface antigen and hepatitis C antibody; patients who are hepatitis C antibody (Ab) positive can be eligible if they are polymerase chain reaction (PCR)-negative
• Active or history of autoimmune disease including but not limited to: rheumatoid arthritis (rheumatoid factor [RF]-positive with current or recent flare), inflammatory bowel disease, systemic lupus erythematosis (clinical evidence with antinuclear antibody [ANA] 1:80 or greater), ankylosing spondylitis, scleroderma, multiple sclerosis, autoimmune hemolytic anemia, and immune thrombocytopenic purpura; seropositivity alone will not be considered active autoimmunity; patients with immune-mediated hypothyrodisim and/or vitiligo are allowed
• Active gastrointestinal bleeding or uncontrolled peptic ulcer disease