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Investigator(s):
Steven A. Rosenberg, M.D., Ph.D. Principal Investigator Phone: 1-866-820-4505 (Toll Free) ncisbirc@mail.nih.gov
Referral Contact(s):
Linda Williams, R.N. Research Nurse Phone: 1-866-820-4505 (Toll Free) Fax: 301-451-1927 ncisbirc@mail.nih.gov	June A. Kryk, R.N. Research Nurse Phone: 1-866-820-4505 (Toll Free) Fax: 301-451-1927 ncisbirc@mail.nih.gov

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Primary Eligibility:

• ≥ 18 years of age
• Histologically confirmed metastatic cancer
• Tumor expresses carcinoembryonic antigen (CEA)
• HLA-A*0201 positive
• Must have previously received systemic standard of care (or effective salvage chemotherapy regimens) for metastatic disease, and have been either non-responders (progressive disease) or have recurred
• No concurrent systemic steroid therapy
• Not pregnant or nursing; fertile patients must use effective contraception during treatment and for up to 4 months after receiving preparative regimen
• No medical condition that would preclude study participation, such as active systemic infections; coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system; myocardial infarction; cardiac arrhythmias; obstructive or restrictive pulmonary disease
• HIV, hepatitis B, and hepatitis C negative
• No contraindications for high-dose aldesleukin administration

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Study Outline:

This is a Phase I dose-escalation study of anti-CEA cells followed by a Phase II study. Patients enrolled in the Phase II portion are stratified according to cancer type (metastatic colorectal cancer vs other types of metastatic cancers).

Leukapheresis and cell preparation:

• Patients undergo leukapheresis to obtain peripheral blood mononuclear cells
• Cells are then genetically modified and grown in the laboratory

Nonmyeloablative, lymphocyte-depleting preparative regimen:

• Patients receive cyclophosphamide IV over 1 hour on Days 1 and 2 and fludarabine phosphate IV over 30 minutes on Days 3–7

Anti-CEA cell infusion and high-dose aldesleukin:

• Patients receive anti-CEA cells IV over 20–30 minutes on Day 8


• Patients will also receive an infusion of aldesleukin three times a day beginning on Day 8 and continuing for up to 5 days; patients are evaluated 4–6 weeks after completion of aldesleukin treatment
• Patients whose tumors achieve partial response or stable disease and then subsequently progress may receive another course of treatment beginning 12–24 weeks after completion of aldesleukin
• Blood samples are collected periodically
• After completion of study treatment, patients are followed periodically for up to 15 years

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/9/09
Updated: 5/14/09