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
Trial Information
Current as of July 24, 2025
Completed
Keywords
ClinConnect Summary
No description provided
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).
About Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is a leading research and treatment facility dedicated to advancing the understanding and treatment of cancer. Renowned for its multidisciplinary approach, the center integrates cutting-edge research with patient care, fostering innovation in cancer therapies and prevention strategies. With a commitment to translational medicine, the center conducts clinical trials that aim to bring laboratory discoveries directly to patients, enhancing therapeutic options and improving outcomes. As a National Cancer Institute-designated comprehensive cancer center, it emphasizes collaboration among researchers, clinicians, and patients to tackle the complexities of cancer and develop personalized treatment plans.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Baltimore, Maryland, United States
Patients applied
Trial Officials
Evan J Lipson, M.D.
Principal Investigator
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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