AlloStim® In-Situ Vaccine in Pre-Treated Metastatic Colorectal Cancer

PHASE2/PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

December 31, 2017

Primary Completion Date

December 31, 2019

Study Completion Date

October 31, 2020

Conditions
Metastatic Colorectal Cancer
Interventions
BIOLOGICAL

AlloStim®

AlloStim® is derived from the blood of normal blood donors and is intentionally mismatched to the recipient. CD4+ T-cells are separated from the blood and differentiated and expanded for 9-days in culture to make an intermediary called T-Stim. AlloStim is made by incubating T-Stim cells for 4h with antibody coated microbeads. The cells with the beads still attached are suspended in infusion media and loaded into syringes. The syringes are shipped refrigerated to the point-of-care.

PROCEDURE

cryoablation

percutaneous ablation of a single metastatic tumor lesion usually in liver. The procedure is conducted under CT or ultrasound image-guidance.

OTHER

Physician's Choice (PC)

Physician's Choice therapy can consist of best supportive care (BSC) or any US-FDA approved cancer drug (e.g. Cetuximab) administrated as a monotherapy at the manufacturer's recommended dose. The treatment schedule shall be prospectively determined and administered as tolerated

Trial Locations (1)

Unknown

National Cancer Institute of Thailand, Bangkok

Sponsors
All Listed Sponsors
lead

Mirror Biologics, Inc.

INDUSTRY

NCT01741038 - AlloStim® In-Situ Vaccine in Pre-Treated Metastatic Colorectal Cancer | Biotech Hunter | Biotech Hunter