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Modified White Blood Cells That Secrete IL-2 and Express a Protein That Targets the ESO-1tumor Protein for Metastatic Cancer

NCT01457131 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-01-08

No results posted yet for this study

Summary

Background:

\- A new cancer treatment involves collecting white blood cells from an individual, modifying them to secrete IL-2 and target the ESO-1 protein expressed on some cancers, and returning them to the body. The cells may then be able to seek out the cancer cells and destroy them. Some kinds of cancer contain a protein called ESO-1, which is found on the surface of the cells. Doctors want to modify white blood cells to have an anti-ESO-1 effect, and use them to treat the cancer that has the ESO-1. In addition to adding genes that target the ESO-1 protein to the cells, the genes for IL-12 are added to the cells. IL-12 is a protein that stimulates the immune system. This type of therapy is called gene transfer.

Objectives:

\- To test the safety and effectiveness of anti-ESO-1/IL-12 white blood cells against metastatic cancer.

Eligibility:

\- Individuals at least 18 years of age who have metastatic cancer that expresses ESO-1 and has not responded to standard treatments.

Design:

* Participants will be screened with a medical history and physical exam. They will also have blood tests and imaging studies.
* Participants will have leukapheresis about a month before the treatment to collect white blood cells.
* They will have chemotherapy 5 days before the treatment to suppress the immune system, and prepare the body for the anti-ESO-1/IL-12 cells.
* The anti-ESO-1/IL-12 cells will be given as an infusion.
* Participants will be monitored in the hospital during their recovery from the treatment.
* Participants will have regular followup exams every 1 to 6 months. The exams will include blood tests, imaging studies, and other studies.

Due to toxicities seen with the regimen, it was decided not to pursue the phase 2 portion of the study.

Conditions

Interventions

DRUG

Fludarabine

50 mg/m2, IV(in the vein)on day 5 of each 25 day cycle

DRUG

Cyclophosphamide

60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days

OTHER

IL-12 & Anti-NY ESO1 TCR PBL

10(7) cells to 3 X 10(10) cells

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Steven A Rosenberg, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-06
Primary Completion
2013-08-07
Completion
2013-08-07

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT01457131 on ClinicalTrials.gov