Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
With
The John P. Hussman Foundation
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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).
Clareo Health | Safety Study of a Melanoma Vaccine (GVAX) With or Without Cyclophosphamide in Patients With Surgically Resected Melanoma
