Recurrent Melanoma Clinical Trial
Official title:
A Randomized, Placebo-Controlled Phase III Trial of Yeast Derived GM-CSF Versus Peptide Vaccination Versus GM-CSF Plus Peptide Vaccination Versus Placebo in Patients With "No Evidence of Disease" After Complete Surgical Resection of "Locally Advanced" and/or Stage IV Melanoma
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.
PRIMARY OBJECTIVES:
I. To compare overall survival and disease-free survival of patients with completely resected
stage IV melanoma or stage III melanoma with gross extranodal extension, satellites, and/or
intransit lesions, treated with granulocyte macrophage colony-stimulating factor (GM-CSF)
(sargramostim) vs. no GM-CSF, or other high risk patients listed in the eligibility section.
SECONDARY OBJECTIVES:
I. To compare, using a 2 x 2 factorial design, overall survival and disease-free survival of
human leukocyte antigen (HLA)-A2 positive patients treated with peptide vaccination vs. no
peptide vaccination.
II. The following descriptive evaluations of survival and disease-free survival are planned
for the HLA-A2 positive patients: (1) GM-CSF plus peptide vaccination vs. peptide vaccination
alone; (2) GM-CSF plus peptide vaccination vs. GM-CSF alone; (3) GM-CSF plus peptide
vaccination vs. placebo.
III. Survival and disease-free survival of HLA-A2 positive patients not receiving peptide
vaccination will be compared to that of HLA-A2 negative patients not receiving peptide
vaccination.
IV. To determine the influence of GM-CSF on circulating dendritic cell numbers and
subpopulations in peripheral blood of patients receiving and not receiving GM-CSF.
V. To determine, in HLA-A2 positive patients, whether immunization with peptides with or
without GM-CSF elicits a measurable T-cell response as assessed by enzyme-linked
immunosorbent spot (ELISPOT) and the major histocompatibility complex (MHC) tetramer assay,
and to determine the functionality of these cells by intracellular cytokine staining.
OUTLINE: HLA-A2 positive patients are randomized to 1 of 4 treatment regimens (Arms I-IV).
HLA-A2 negative patients are randomized to 1 of 2 treatment arms (Arms V-VI).
ARM I: Patients receive sargramostim subcutaneously (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).
ARM II: 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).
ARM III: 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).
ARM IV: Patients receive sargramostim placebo 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).
ARM V: Patients receive sargramostim SC on days 1-14.
ARM VI: Patients receive sargramostim placebo SC on days 1-14.
In all arms, treatment repeats every 28 days for up to 13 courses in the absence of disease
progression or unacceptable toxicity.
In the event of recurrence, patients who undergo complete resection of the recurrence may
continue treatment for 6 courses or until completion of 1 year of therapy (whichever is
longer). For patients with recurrence that is not surgically resectable or experiencing
second recurrence, treatment will be discontinued.
After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 3 years, and then every 12 months for 10 years.
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