A Phase I/II Trial of a Human Anti-Idiotypic Monoclonal Antibody Vaccine (4B5) Which Mimics the GD2 Antigen, in Patients With Melanoma
OBJECTIVES: I. Determine the toxicity of the human anti-idiotypic monoclonal antibody
vaccine (4B5) plus adjuvant sargramostim (GM-CSF) or alum in patients with stage III or IV
melanoma at high risk for recurrence following surgical resection. II. Determine whether 4B5
is associated with the development of humoral and/or cellular anti-anti-idiotypic immune
response in these patients. III. Determine whether the immune response generated against 4B5
is also directed against the melanoma-associated GD2 antigen in these patients. IV.
Determine whether the 4B5 plus adjuvant GM-CSF or alum can elicit an immune response to GD2
in these patients.
OUTLINE: Patients are assigned sequentially to one of two treatment arms. Arm I: Patients
receive human anti-idiotypic monoclonal antibody vaccine (4B5) in sargramostim (GM-CSF)
subcutaneously (SQ) on days 0, 14, 28, and 42. Patients receive GM-CSF alone SQ at
vaccination site on days 2, 3, and 4 following immunization. Arm II: Patients receive 4B5
plus alum SQ on days 0, 14, 28, and 42. Cohorts of 5 patients receive treatment every 2
weeks for up to 4 courses in the absence of unacceptable toxicity.
PROJECTED ACCRUAL: A maximum of 50 patients (25 per arm) will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Compare AEs and SAES in subjects receiving 4B5 plus adjuvant sargramostim (GM-CSF) to alum in patients with stage III or IV melanoma at high risk for recurrence following surgical resection.
Baseline to last dose of study drug
Donald M. Miller, MD, PhD
James Graham Brown Cancer Center at University of Louisville
United States: Federal Government