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Cohort A will receive four doses of vaccine, each containing 5E7 melanoma GVAX cells.

Cohort B will receive four doses of vaccine, each containing 2E8 melanoma GVAX cells.

Cohort C will receive four doses of vaccine, each containing 2E8 melanoma GVAX cells. One day prior to each vaccination, patients in cohort C will receive a single, low dose of intravenous cyclophosphamide.

Melanoma GVAX is given as intradermal injections every 28 days x 4 doses. Cohort A will receive 5E7 cells/dose; cohorts B and C will receive 2E8 cells/dose.

melanoma GVAX

200mg/m2 given as a single dose, intravenously, one day prior to each of the 4 vaccinations to patients in cohort C only

Evan J Lipson, M.D.

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.

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

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

To determine the side effects and tolerability of administering an allogeneic GM-CSF-secreting lethally irradiated whole melanoma cell vaccine ("melanoma GVAX"), alone or in combination with low dose cyclophosphamide, for the adjuvant treatment of patients with surgically resected stage IIB-IV melanoma.

We 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 cyclophosphamide. These investigations are exploratory in nature and will not affect clinical care.

The John P. Hussman Foundation

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety Study of a Melanoma Vaccine (GVAX) With or Without Cyclophosphamide in Patients With Surgically Resected Melanoma	NCT01435499	Melanoma	melanoma GVAX Cyclophosphamid...	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Safety Study of a Melanoma Vaccine (GVAX) With or Without Cyclophosphamide in Patients With Surgically Resected Melanoma	NCT01435499	Melanoma	melanoma GVAX Cyclophosphamid...	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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