Sargramostim, Vaccine Therapy, or Sargramostim and Vaccine Therapy in Preventing Disease Recurrence in Patients With Melanoma That Has Been Removed By Surgery

Summary

This randomized phase III trial studies sargramostim or vaccine therapy alone to see how well they work compared to sargramostim and vaccine therapy together in preventing disease recurrence in patients with melanoma that has been removed by surgery. Sargramostim may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known whether yeast derived sargramostim and vaccine therapy are more effective alone or together in preventing recurrence of melanoma.

Conditions

• Iris Melanoma
• Medium/Large Size Posterior Uveal Melanoma
• Mucosal Melanoma
• Ocular Melanoma With Extraocular Extension
• Recurrent Melanoma
• Recurrent Uveal Melanoma
• Small Size Posterior Uveal Melanoma
• Stage IIA Cutaneous Melanoma AJCC v6 and v7
• Stage IIA Uveal Melanoma AJCC v7
• Stage IIB Cutaneous Melanoma AJCC v6 and v7
• Stage IIB Uveal Melanoma AJCC v7
• Stage IIC Cutaneous Melanoma AJCC v6 and v7
• Stage IIIA Cutaneous Melanoma AJCC v7
• Stage IIIA Uveal Melanoma AJCC v7
• Stage IIIB Cutaneous Melanoma AJCC v7
• Stage IIIB Uveal Melanoma AJCC v7
• Stage IIIC Cutaneous Melanoma AJCC v7
• Stage IIIC Uveal Melanoma AJCC v7
• Stage IV Cutaneous Melanoma AJCC v6 and v7
• Stage IV Uveal Melanoma AJCC v7

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Placebo

Given GM-CSF placebo SC

OTHER

Placebo

Given peptide placebo SC

BIOLOGICAL

Sargramostim

Given SC

BIOLOGICAL

Tyrosinase Peptide

Given SC

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• David H Lawson · Eastern Cooperative Oncology Group

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2000-02-23

Primary Completion

2012-10-08

Completion

2013-01-31

Countries

• United States

Study Locations