Vaccination of Melanoma Patients With Total or CD25-depleted Peripheral Blood Mononuclear Cell (PBMC)
|Melanoma||Biological: PBMC re-infusion Biological: CD25 depletion||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Vaccination of Chemotherapy Induced Lymphopenic Unresectable Stage III or Stage IV Melanoma Patients Following Reconstitution With Total or CD25-depleted PBMC|
- Immunologic effects (changes in the number of tumor specific T cells) [ Time Frame: Up to day 119 ]The absolute number and frequency of tumor specific T cells will be measured at days 7, 21, 35, 64, 91, and day 119.
- The number and severity of adverse events [ Time Frame: Up to day 119 ]Adverse events will be assessed on Days 7, 21, 35, 64, 91, and 119. Of special interest will be any adverse events thought to represent an autoimmune reaction.
|Study Start Date:||July 2009|
|Estimated Study Completion Date:||December 2016|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Cohort A
Biological: PBMC re-infusion
Autologous PBMC re-infusion
Experimental: Cohort B
Biological: CD25 depletion
Autologous, CD25-depleted PBMC re-infusion
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 follows:
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00961376
|United States, Oregon|
|Providence Portland Medical Center|
|Portland, Oregon, United States, 97213|
|Principal Investigator:||Brendan Curti, MD||Providence Health & Services|