Vaccination of Chemotherapy Induced Lymphopenic Unresectable Stage III or Stage IV Melanoma Patients Following Reconstitution With Total or CD25-depleted PBMC
This is an open-label, outpatient Phase II, prospective, randomized, single-center, clinical
trial. Up to 14 patients with a diagnosis of unresectable stage III or stage IV melanoma.
All patients will undergo leukapheresis to collect PBMC.
All patients will receive Cyclophosphamide 350 mg/m2 dl-3 and Fludarabine 20 mg/m2 dl-3.
Following chemotherapy to induce lymphopenia, patients will be re-infused with PDMC as
Autologous PBMC re-infusion (Cohort A) Autologous, CD25-depleted PBMC re-infusion (Cohort B)
Following PBMC re-infusion, all patients will receive subcutaneous GM-CSF Infusion (50
micrograms/24 hrs) continuously for 6 days.
All patients will then receive 4 booster vaccinations as follows:
Intradermal injection of autologous tumor cells in the lower abdomen to deliver a total dose
of at least 2x107 cells administered week 3, week 5, week 9 and week 13. Subcutaneous GM-CSF
Infusion (50 micrograms/24 hrs) adjacent to the vaccine site begins at time of vaccination
(week 3, 5, 9 and 13) and continues for 6 days.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Immunologic effects (changes in the number of tumor specific T cells)
The absolute number and frequency of tumor specific T cells will be measured at days 7, 21, 35, 64, 91, and day 119.
Up to day 119
United States: Food and Drug Administration
PHS IRB 06-55
|Providence Portland Medical Center||Portland, Oregon 97213-3635|