A Pilot Trial of Therapeutic Vaccination With a Modified gp100 Melanoma Peptide (gp100:209-217(210M)), Montanide ISA 51, and KLH With Reconstitution After Chemotherapy to Induce Lymphopenia in Patients With Metastatic Melanoma
- Determine the toxicity and immune effects of vaccination comprising modified gp100
peptide (gp100:209-217[210M]), Montanide ISA-51, and keyhole limpet hemocyanin followed
by peripheral blood mononuclear cell reinfusion after treatment-induced lymphopenia
with fludarabine in patients with unresectable or metastatic melanoma.
- Determine the induction of antigen-specific T-cell responses in patients treated with
- Determine the kinetics and duration of immune response in patients treated with this
- Compare the immunologic effects of this regimen in these patients with historical
- Compare 2 different dosing schedules of fludarabine, in terms of induction of
lymphopenia and granulocytopenia and on the induction of a specific immune response to
this vaccine, in these patients.
OUTLINE: This is a pilot, randomized study. Patients are randomized to 1 of 2 treatment
Within 2 weeks before the start of fludarabine, all patients undergo leukapheresis over 4-6
hours for the collection of peripheral blood mononuclear cells (PBMCs).
- Arm I: Patients receive fludarabine IV over 30 minutes on days 1-5.
- Arm II: Patients receive fludarabine as in arm I on days 1, 3, and 5. In both arms,
patients receive autologous PBMCs IV over approximately 30 minutes on day 8 and
vaccination comprising gp100:209-217(210M) peptide, Montanide ISA-51, and keyhole
limpet hemocyanin subcutaneously on days 8, 22, 36, 50, and 64. Patients with stable or
responding disease continue to receive vaccination on day 78 and then every 28-31 days
for up to 1 year.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 20 patients (10 per treatment arm) will be accrued for this
study within 2 years.
Allocation: Randomized, Primary Purpose: Treatment
Toxicity by clinical and laboratory observation at 1 month
Walter J. Urba, MD, PhD
Providence Cancer Center, Earle A. Chiles Research Institute
United States: Federal Government
|Providence Cancer Center at Providence Portland Medical Center||Portland, Oregon 97213-2967|