Status:
COMPLETED
Safety Study of a Melanoma Vaccine (GVAX) With or Without Cyclophosphamide in Patients With Surgically Resected Melanoma
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
The John P. Hussman Foundation
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to evaluate the safety and feasibility of administering an allogeneic GM-CSF-secreting lethally irradiated whole melanoma cell vaccine ("melanoma GVAX"), alone o...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01435499
Start Date
September 1 2011
End Date
March 1 2016
Last Update
May 24 2016
Active Locations (1)
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1
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231