Neoadjuvant Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Cutaneous Stage L-lll Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: GM-CSF; Standard of Care
Intervention description: 14 days in a dose of 125 µg/m^2; No neo-adjuvant therapy prior to surgical intervention
Intervention MeSH terms: Sargramostim
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Randomized trial to determine if neo-adjuvant subcutaneous GM-CSF restores the host regional
      lymph node immunity
    

Eligibility criteria:

        Inclusion Criteria

        To be eligible for the study, patients must satisfy the following criteria:

          -  Histologically confirmed primary cutaneous malignant melanoma

          -  1-4mm Breslow depth

          -  Scheduled for sentinel lymph node biopsy as part of their standard surgical management

          -  Man or woman, age >/= 18 years

          -  Women of childbearing potential (WOCBP) must be using an adequate method of
             contraception to avoid pregnancy throughout the study and for up to 2 weeks after the
             study in such a manner that the risk of pregnancy is minimized. WOCBP include any
             female who has experienced menarche and who has not undergone successful surgical
             sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal.
             Sexually active WOCBP must use an effective method of birth control during the course
             of the study, in a manner such that risk of failure is minimized. All WOCBP must have
             a negative pregnancy test prior to first receiving GM-CSF.

          -  Men must agree to use and utilize an adequate method of contraception throughout
             treatment and for at least 2 weeks after study drug is stopped

          -  All patients must be willing and able to give written informed consent.

        Exclusion Criteria Subjects meeting any of the following criteria are ineligible for study
        entry

          -  Clinical stage III or IV disease

          -  Autoimmune disease: Patients with a history of inflammatory bowel disease are excluded
             from this study as are patients with a history of immunologic disease (e.g. rheumatoid
             arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis, motor
             neuropathy considered of autoimmune origin)

          -  Any underlying medical conditions which, in the opinion of the investigator, will make
             the administration of GM-CSF hazardous or obscure the interpretation of adverse
             events; such as, psychological, familial, sociological or geographical conditions
             potentially hampering compliance with the study protocol and followup schedule

          -  Any vaccination therapy within 4 weeks prior to GM-CSF administration

          -  Concomitant therapy with any of the following within the past 3 months: GM-CSF,
             interferon, other non-study immunotherapy regimes; cytotoxic chemotherapy

          -  Immunosuppressive mediations (steroids, tumor necrosis factor (TNF)-inhibitors,
             azathioprine, etc.) within the past 6 weeks

          -  Active or chronic infection with HIV, hepatitis B or hepatitis C

          -  WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for
             the entire study period and 2 weeks after cessation of the study drug.

          -  Prisoners or subjects who are compulsorily detained