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

Recruiting in Palo Alto (17 mi)

+147 other locations

Overseen byDavid H Lawson

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

David H Lawson

Principal Investigator

Eastern Cooperative Oncology Group

Eligibility Criteria

Inclusion Criteria

Stage II disease with gross extracapsular extension

Recurrence in a previously resected nodal basin

Four or more involved lymph nodes or matted lymph nodes

See 7 more

Treatment Details

Interventions

Sargramostim (Cytokine)
Tyrosinase Peptide (Cancer Vaccine)

Participant Groups

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm V (sargramostim)Experimental Treatment2 Interventions

Patients receive sargramostim SC on days 1-14.

Group II: Arm III (sargramostim, peptide placebo)Experimental Treatment3 Interventions

Patients receive sargramostim SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

Group III: Arm II (sargramostim placebo, peptide vaccine)Experimental Treatment3 Interventions

Patients receive sargramostim placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

Group IV: Arm I (sargramostim, peptide vaccine)Experimental Treatment3 Interventions

Patients receive sargramostim SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

Group V: Arm VI (sargramostim placebo)Placebo Group2 Interventions

Patients receive sargramostim placebo SC on days 1-14.

Group VI: Arm IV (placebo, peptide placebo)Placebo Group2 Interventions

Patients receive placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).