Vaccination of Melanoma Patients With Total or CD25-depleted Peripheral Blood Mononuclear Cell (PBMC)
|ClinicalTrials.gov Identifier: NCT00961376|
Recruitment Status : Terminated (PI Discretion)
First Posted : August 19, 2009
Last Update Posted : September 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Biological: PBMC re-infusion Biological: CD25 depletion||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vaccination of Chemotherapy Induced Lymphopenic Unresectable Stage III or Stage IV Melanoma Patients Following Reconstitution With Total or CD25-depleted PBMC|
|Study Start Date :||July 2009|
|Primary Completion Date :||January 2015|
|Estimated Study Completion Date :||December 2016|
Active Comparator: Cohort A
Biological: PBMC re-infusion
Autologous PBMC re-infusion
Experimental: Cohort B
Biological: CD25 depletion
Autologous, CD25-depleted PBMC re-infusion
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00961376
|United States, Oregon|
|Providence Portland Medical Center|
|Portland, Oregon, United States, 97213|
|Principal Investigator:||Brendan Curti, MD||Providence Health & Services|