αDC1 Vaccine + Chemokine Modulatory Regimen (CKM) as Adjuvant Treatment of Peritoneal Surface Malignancies

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

July 31, 2014

Primary Completion Date

February 18, 2019

Study Completion Date

February 18, 2019

Conditions
Malignant Neoplasm of Pancreas Metastatic to Peritoneal SurfaceMalignant Peritoneal MesotheliomaPeritoneal Carcinomatosis
Interventions
BIOLOGICAL

DC vaccine

Administered on Monday of each cycle: 1 intranodal ultrasound-guided injection (target dose of 3 x 10e6 cells in 0.5 mL) + 1 intradermal injection (target dose of 3 x 10e6 cells in 0.5 mL)

DRUG

Celecoxib

Administered at 200 mg, once a day orally, starting the day of the first DC vaccine through week 4/cycle 2. Participants will not take celecoxib while receiving standard of care chemotherapy as instructed by their local oncologist. Celecoxib will continue starting week 20/cycle 3 and continue until the Friday of the last day of the CKM administration, cycle 4. Administered at 400 mg, 200 mg twice a day orally, on days participants receive vaccine and CKM.

DRUG

Interferon Alfa-2b

Intravenous infusion over 20 minutes: doses tested in Phase 1 portion (5, 10, or 20 MU/m2) will determine the Phase 2 dose. Administered on the Tuesday of each CKM cycle.

BIOLOGICAL

rintatolimod

Intravenous infusion of 200 mg on Wednesday and Friday only of the CKM regimen. The protocol allows for de-escalation to 100 mg if attributable adverse effects are observed.

Trial Locations (1)

15232

UPMC Hillman Cancer Center, Pittsburgh

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

David Bartlett

OTHER

NCT02151448 - αDC1 Vaccine + Chemokine Modulatory Regimen (CKM) as Adjuvant Treatment of Peritoneal Surface Malignancies | Biotech Hunter | Biotech Hunter