Spots Global Cancer Trial Database for Booster Vaccination in Preventing Disease Recurrence in Previously Vaccinated Patients With Melanoma That Has Been Removed By Surgery

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Trial Identification

Brief Title: Booster Vaccination in Preventing Disease Recurrence in Previously Vaccinated Patients With Melanoma That Has Been Removed By Surgery

Official Title: A Pilot Study to Assess the Immunologic Response to Booster Vaccination With a Modified gp100 Melanoma Peptide (209-2M) Vaccine in Previously Vaccinated HLA-A2.1+ Patients With Melanoma

Study ID: NCT01989559

Conditions

Recurrent Melanoma

Stage IA Skin Melanoma

Stage IB Skin Melanoma

Stage IIA Skin Melanoma

Stage IIB Skin Melanoma

Stage IIC Skin Melanoma

Stage IIIA Skin Melanoma

Stage IIIB Skin Melanoma

Stage IIIC Skin Melanoma

Stage IV Skin Melanoma

Interventions

gp100:209-217(210M) Peptide Vaccine

HPV 16 E7:12-20 Peptide Vaccine

Laboratory Biomarker Analysis

Study Description

Brief Summary: This pilot clinical trial studies booster vaccination in preventing disease recurrence in previously vaccinated patients with melanoma that has been removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer.

Detailed Description: PRIMARY OBJECTIVES: I. To assess the toxicity of booster vaccination with the gp100 (gp100:209-217(210M) peptide vaccine) and human papilloma virus (HPV) peptides in Montanide ISA 51 or Montanide ISA 51 VG administered \>= 12 months after the last immunization. II. To measure the T-cell response to the modified gp100: 209-217 (210M) peptide and the unmodified native gp100 peptide following booster vaccination \>= 12 months after the last immunization. III. To measure the T-cell response to the control human leukocyte antigen (HLA)-A2 restricted clusters of differentiation (CD)8 epitope of papilloma virus HPV16E7:12-20 following booster vaccination \>= 12 months after the last immunization. IV. To perform detailed studies of the memory T cells persisting \>= 12 months after immunization. OUTLINE: Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine with Montanide ISA 51 VG or Montanide ISA 51 subcutaneously (SC) on day 1 and between days 25-30. After 6 months, patients free of disease receive booster injections every 6 months for 3 years in the absence of unacceptable toxicity or disease progression. After completion of study treatment, patients are followed up at 6 months, every 6 months for 5 years, and then annually thereafter.