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

Johns Hopkins Medicine

Status and phase: Completed; Phase 1

Conditions: Melanoma

Treatments: Biological: melanoma GVAX; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT01435499

J1112

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 3 patient groups

Cohort A

Experimental group

Description:

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

Treatment:

Biological: melanoma GVAX

Cohort B

Experimental group

Description:

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

Treatment:

Biological: melanoma GVAX

Cohort C

Experimental group

Description:

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.

Treatment:

Drug: Cyclophosphamide

Biological: melanoma GVAX