Safety Study of a Melanoma Vaccine (GVAX) With or Without Cyclophosphamide in Patients With Surgically Resected Melanoma

Launched by SIDNEY KIMMEL COMPREHENSIVE CANCER CENTER AT JOHNS HOPKINS · Sep 14, 2011

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Any patient age ≥18 years with melanoma of cutaneous or mucosal origin, and with clinicopathologic stage IIB, IIC, III or IV that has been completely resected
• • Patients must be able to provide informed consent.
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• • Life expectancy of at least 6 months.
• • Adequate hematologic function.
• • Adequate renal function
• • Adequate hepatic function
• • Patients of both genders must agree to practice effective birth control during the study period and for at least 4 weeks after the last treatment.
• Exclusion Criteria:
• • Patients whose primary site of melanoma is ocular.
• • Are undergoing or have undergone in the past 4 weeks any systemic treatment for melanoma.
• • Are undergoing or have undergone in the past 2 weeks any surgery or focal radiation therapy.
• • Have active systemic infections, coagulation disorders (including therapeutic anticoagulation), or other major medical or psychiatric illnesses.
• • Are known to be positive for hepatitis B surface antigen, anti-Hepatitis C Virus or anti-Human Immunodeficiency Virus (HIV) antibody (because of possible immune effects of these conditions).
• • Documented history of autoimmune disease, for example, systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis.
• • Any form of primary or secondary immunodeficiency. This would include hereditary disorders such as ataxia-telangiectasia or Wiskott-Aldrich syndrome, or acquired immune deficiencies such as following bone marrow transplantation.
• • Requirement for systemic steroid therapy or immunosuppressive therapy.
• • Have received any type of cancer immunotherapy, including but not limited to interleukin-2, interferon alfa or melanoma vaccines.
• • Have been diagnosed with another invasive cancer within the past 3 years.
• • Radiographic evidence of melanoma recurrence.
• • Pregnant or lactating women.
• • Known or suspected hypersensitivity to GM-CSF, pentastarch, hetastarch, corn, Dimethyl sulfoxide, fetal bovine serum or trypsin (porcine origin).