CEA-Expressing Liver Metastases Safety Study of Intrahepatic Infusions of Anti-CEA Designer T Cells

NCT01373047 | Completed Phase 1 DMC

• 1 other identifier: RWH 335-99
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to collect data on the safety and potential effectiveness of 2nd generation designer T cells delivered into the hepatic circulation in patients with liver metastases expressing the CEA tumor marker. Designer T cells are prepared by collecting white blood cells from the participant, and then modifying these cells in the laboratory so that they recognize the tumor antigen, CEA. These modified cells are then given back into the participant so that they can attack and kill tumor cells. The investigators hypothesize that regional delivery of the designer T cells directly into the hepatic artery will minimize systemic toxicity and optimize the changes for therapeutic effect.

Conditions

Liver Metastases

Keywords

liver metastases; immunotherapy; regional therapy; T cells

Outcome Measures

Primary Outcomes (1)

• Determine the safety of modified T cells delivered into the hepatic artery by documenting the type and severity of any side effects and establishing the Maximum Tolerated Dose (MTD).

  1 month

Secondary Outcomes (3)

• Tumor Response by CT or MRI and PET scan

  1 month

• Designer T cell distribution following infusion

  1 month

• Designer T cell survival and phenotype following infusion

  1 month

Study Arms (1)

Intrahepatic anti-CEA designer T cells

EXPERIMENTAL

Biological: anti-CEA 2nd generation designer T cells

Interventions

anti-CEA 2nd generation designer T cells BIOLOGICAL

Three infusions of gene-modified T cells over the course of 6 weeks into the hepatic artery via a percutaneous approach.

Also known as: anti-CEA T cells, designer T cells

Intrahepatic anti-CEA designer T cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of CEA+ adenocarcinoma and liver metastases
• Liver metastases must be CEA-expressing as demonstrated by elevated serum CEA levels (≥10ng/ml) or immunohistochemistry on a biopsy specimen
• Failure on at least one line of standard systemic chemotherapy and have unresectable liver disease
• Measurable liver disease (\> 1.0 cm by CT or MRI)
• Extrahepatic disease is acceptable when limited to the lungs and/or abdominal lymph nodes
• At least 18 years of age
• Able to understand and sign informed consent
• Life expectancy of greater than four months
• Good performance status (PS 0-1)

You may not qualify if:

• Pregnancy
• Serious medical conditions including but not limited to liver, cardiopulmonary, and renal disease
• Patients with a history of portal hypertension, cirrhosis, hepatitis, or with radiographic evidence of cirrhosis
• Concurrent malignancy
• Use of systemic steroids

Sponsors & Collaborators

• Roger Williams Medical Center: lead

Study Sites (1)

Roger Williams Medical Center

Providence, Rhode Island, 02908, United States

Location

Related Links

• Roger Williams Surgical Oncology

Study Officials

• Steven C Katz, MD

  Roger Williams Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2011
• First Posted: June 14, 2011
• Study Start: June 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 30, 2013

Record last verified: 2013-07

Locations

US (1)