Anti-CD3 x Anti-Erbitux® Armed Activated T Cells (Phase Ib) for Gastrointestinal (GI Cancer)

PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

August 17, 2011

Primary Completion Date

October 19, 2020

Study Completion Date

October 19, 2020

Conditions
Colorectal CancerCancer of PancreasPancreatic NeoplasmMalignant Neoplasm of Large IntestineMalignant Tumor of ColonColon CarcinomaCancer of ColonPancreatic Cancer
Interventions
DRUG

FOLFOX6

IV administration of 85 mb/m(2) oxaliplatin and 400 mg/m(2) leucovorin over 120 mins, followed by 400 mg/m(2) 5-fluorouracil (FU) bolus then 2400 mg/m(2) 5-FU as a 46 hr infusion. All patients must have central intravenous acess (e.g. mediport, PICC line) for continuous infusion of 5-FU. Adv. colorectal and pancreatic pts. w/no other standard chemo available, \& in pts who cannot receive FOLFOX chemo, immunotherapy may be given w/o antecedent chemo.

BIOLOGICAL

EGFRBi armed ATC Infusions

Armed ATC will be infused intravenously (IV) with the rate of infusion based on the endotoxin content of the product. All patients will be observed for at least 4 hours after an infusion. Armed ATC infusions will begin 3 weeks after chemotherapy and subsequent doses will be administered once weekly, for 3 weeks, then 12 weeks post aATC#1. Dose escalation level(per infusion): Level 0-5 billion; Level 1-10 billion; Level 2-20 billion; Level 3-40 billion

Trial Locations (1)

48601

Barbara Ann Karmanos Cancer Institute, Detroit

All Listed Sponsors
lead

Barbara Ann Karmanos Cancer Institute

OTHER

NCT01420874 - Anti-CD3 x Anti-Erbitux® Armed Activated T Cells (Phase Ib) for Gastrointestinal (GI Cancer) | Biotech Hunter | Biotech Hunter