Safety Study of a Melanoma Vaccine (GVAX) With or Without Cyclophosphamide in Patients With Surgically Resected Melanoma
| Status: | Completed |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/25/2016 |
| Start Date: | September 2011 |
| End Date: | March 2016 |
A Feasibility and Toxicity Study of a Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Secreting Allogeneic Melanoma Vaccine Administered Alone or in Combination With Cyclophosphamide in Subjects With Surgically Resected At-Risk Melanoma
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 or in combination with low dose cyclophosphamide (CPM), for the
adjuvant treatment of patients with surgically resected stage IIB-IV melanoma. Secondarily,
the investigators will assess in vitro correlates of anti-melanoma immunization by melanoma
GVAX, including serological and cellular immune responses in patients treated with either
the vaccine alone or the vaccine given with low dose CPM.
administering an allogeneic GM-CSF-secreting lethally irradiated whole melanoma cell vaccine
("melanoma GVAX"), alone or in combination with low dose cyclophosphamide (CPM), for the
adjuvant treatment of patients with surgically resected stage IIB-IV melanoma. Secondarily,
the investigators will assess in vitro correlates of anti-melanoma immunization by melanoma
GVAX, including serological and cellular immune responses in patients treated with either
the vaccine alone or the vaccine given with low dose CPM.
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).
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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