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Gene Therapy Using Anti-CEA Cells to Treat Metastatic Cancer

NCT00923806 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2026-01-23

No results posted yet for this study

Summary

Background:

* Carcinoembryonic antigen (CEA) is a protein present mostly in cancer cells.
* An experimental procedure developed for treating patients with cancer uses blood cells found in their tumors or bloodstream. These cells are genetically modified using the anti-CEA gene and a type of virus. The modified cells (anti-CEA cells) are grown in the laboratory and then given back to the patient to try to decrease the size of the tumors. This is called gene therapy.

Objectives:

* To determine whether advanced cancers that that express the CEA antigen can be treated effectively with lymphocytes (white blood cells) that have been genetically engineered to contain an anti-CEA protein.

Eligibility:

* Patients 18 years of age and older with metastatic cancer (cancer that has spread beyond the original site) and for whom standard treatments are not effective.
* Patients' tumors express the CEA antigen.
* Patients have the human leukocyte (HLA-A\*0201) antigen.

Design:

* Workup with scans, x-rays and other tests.
* Leukapheresis to obtain cells for preparing the anti-CEA cells for later infusion.
* 1 week of chemotherapy to prepare the immune system for receiving the anti-CEA cells.
* Infusion of anti-CEA cells, followed by interleukin-2 (IL-2) treatment. The cells are given as an infusion through a vein. IL-2 is given as a 15-minute infusion through a vein every 8 hours for a maximum of 15 doses.
* 1-2 weeks of recovery from the effects of chemotherapy and IL-2.
* Periodic follow-up clinic visits after hospital discharge for physical examination, review of treatment side effects, laboratory tests and scans every 1 to 6 months.

Conditions

Interventions

BIOLOGICAL

PG13-CEA_TCR (Anti-CEA TCR PBL)

DRUG

Aldesleukin

720,000 IU/kg intravenous over 15 minutes every 8 hours for up to 5 days

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Steven Rosenberg, M.D. · National Cancer Institute, National Institutes of Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00923806 on ClinicalTrials.gov