• Return to search results
• Start new search

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

---

Primary Eligibility:

• Histologically confirmed metastatic cancer
• Tumor expresses carcinoembryonic antigen (CEA) as assessed by one of the following methods:
• CEA antibody ≥ 1+ by IHC analysis of resected tumor tissue
• Circulating CEA level > 10 mcg/L by ELISA analysis of serum samples
• HLA-A*0201 positive
• Must have previously received systemic standard 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
• ECOG 0–1
• Absolute neutrophil count > 1,000/mm³ (without filgrastim [G-CSF] support)
• WBC > 3,000/mm³
• Platelet count > 100,000/mm³
• Hemoglobin > 8 g/dL
• ALT and AST ≤ 2.5 x upper limit of normal
• Serum creatinine ≤ 1.6 mg/dL
• Total bilirubin ≤ 1.5 mg/dL (< 3 mg/dL in patients with Gilbert syndrome)
• No documented LVEF ≤ 45% in patients meeting any of the following criteria:
• History of ischemic heart disease or chest pain
• Clinically significant atrial and/or ventricular arrhythmias
• ≥ 60 years of age and over
• No documented FEV₁ ≤ 60% predicted in patients with a prolonged history of cigarette smoking or symptoms of respiratory dysfunction
• 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
• HIV antibody negative, hepatitis B antigen negative, and hepatitis C antibody negative unless antigen negative
• No history of severe immediate hypersensitivity reaction to any of the agents used in this study
• No contraindications for high-dose aldesleukin administration

---

Treatment Plan:

This is a Phase I dose-escalation study of anti-CEA TCR-engineered autologous lymphocytes 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).

Nonmyeloablative, lymphocyte-depleting preparative regimen:

• Patients receive cyclophosphamide IV over 1 hour on Days -7 and -6 and fludarabine phosphate IV over 30 minutes on Days -5 to -1

Anti-CEA TCR-engineered autologous lymphocytes infusion and high-dose aldesleukin:

• Patients receive anti-CEA TCR-engineered autologous peripheral blood lymphocytes IV over 20–30 minutes on Day 0
• Patients also receive filgrastim (G-CSF) subcutaneously beginning on Day 1 or 2 and continuing until blood counts recover
• Patients receive high-dose aldesleukin IV over 15 minutes every 8 hours on Days 1–4

• Patients are evaluated 4–6 weeks after completion of aldesleukin treatment
• Patients who 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

---

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.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 
Updated: 1/8/09