A Randomized Phase II Trial of a Mutated gp100 Melanoma Peptide (g209-217(210M) With Hight Dose Interleukin-2 (IL-2) in HLA-A2.1+Patients With Metastatic Melanoma
- Define the antitumor activity of gp100:209-217 (210M), a melanoma peptide derived from
gp100 mixed with Montanide ISA-51, in combination with high-dose interleukin-2 (IL-2)
administered by various schedules in patients with advanced melanoma.
- Examine the effect of the addition of gp100:209-217 (210M) peptide vaccine to high-dose
IL-2 on the toxicity of the treatment in these patients.
- Define the induction of T-cell responses to gp100:209-217 (210M) peptide and its gp100
(parent) protein by ELISA with interferon gamma production or CTL precursor frequencies
in these patients after the initial course of treatment.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
therapy (adjuvant interferon vs chemotherapy for advanced disease vs both vs none), ECOG
performance status (0 vs 1), and number of organ sites involved (1 vs more than 1). Patients
are randomized into 1 of 3 treatment arms. (Arm III closed to accrual as of 11/30/1998.)
- Arm I: Patients receive vaccination comprising gp100:209-217 (210M) peptide mixed with
Montanide ISA-51 subcutaneously on days 1, 22, 43, and 64. Patients also receive
high-dose interleukin-2 (IL-2) IV over 15 minutes every 8 hours on days 2-6 and 16-20.
- Arm II: Patients receive vaccination as in arm I on days 1, 22, 43, and 64. Patients
also receive high-dose IL-2 as in arm I on days 44-48 and 60-64. Patients who
demonstrate rapid visible disease progression during the initial 4 weeks of therapy
while maintaining good performance status may begin high-dose IL-2 on day 23.
- Arm III (closed to accrual as of 11/30/1998): Patients receive vaccination as in arm I
on day 1 and then high-dose IL-2 as in arm I on day 2. Patients with nonhematologic
toxicity may only receive vaccination on weeks 4, 7, and 10. Other patients may also
receive IL-2 beginning on day 2 of each treatment week (4, 7, and 10) for up to 14
Patients in each arm may receive up to a total of 3 courses of treatment.
Patients are followed until death.
PROJECTED ACCRUAL: Approximately 90 patients (25 patients for arms I and II and 40 patients
for arm III [arm III closed to accrual as of 11/30/1998]) will be accrued for this study
within 12-18 months.
Allocation: Randomized, Primary Purpose: Treatment
David M. Gustin, MD
University of Illinois
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|University of Texas Health Science Center at San Antonio||San Antonio, Texas 78284-7811|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|
|Loyola University Medical Center||Maywood, Illinois 60153|
|University of Illinois at Chicago Health Sciences Center||Chicago, Illinois 60612|
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|
|Comprehensive Cancer Center at Our Lady of Mercy Medical CenterOur||Bronx, New York 10466|
|Vanderbilt University Medical Center||Nashville, Tennessee 37232-2516|