• Return to search results
• Start new search

Investigator(s):
James L. Gulley, M.D., Ph.D., F.A.C.P. Principal Investigator Phone: 301-435-2956 gulleyj@mail.nih.gov
Referral Contact(s):
Laura D. Otten, R.N., B.S.N., O.C.N. Medical Oncology Referral Coordinator Phone: 301-451-1228 1-866-611-6310 (Toll Free) Fax: 301-451-5433 ottenl@mail.nih.gov	Mary Pazdur, C.R.N.P. Nurse Practitioner Phone: 301-496-7870 Fax: 301-480-5094 pazdurm@mail.nih.gov	Myrna Rauckhorst, R.N. Research Nurse Phone: 301-496-7224 mr276f@nih.gov

---

Primary Eligibility:

• Histologically confirmed carcinoma that expresses carcinoembryonic antigen (CEA), as demonstrated by one of the following:
• CEA serum level > 5 ng/mL
• Tumor that stains positive for CEA in > 20% of a tumor block
• Metastatic disease that meets one of the following criteria:
• Measurable disease
• Non-measurable but evaluable disease
• Completed or had disease progression on ≥ 1 prior line of disease-appropriate therapy for metastatic disease OR is not a candidate for therapy of proven efficacy for their disease
• Patients with prostate cancer must continue to receive gonadotropin-releasing hormone agonist therapy unless they have undergone an orchiectomy
• Must be HLA-A2, -A3, or -A24⁺ for immunologic monitoring (extension phase)
• No untreated brain metastasis or local treatment of brain metastasis within the past 6 months
• Hormone receptor status not specified
• Recovered from prior therapy
• ECOG performance status (PS) 0–2 OR Karnofsky PS 50–100% (ECOG PS 0–1 for extension phase)
• Platelet count ≥ 100,000/mm³
• Granulocyte count ≥ 1,500/mm³
• Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR creatinine clearance on a 24-hour urine collection ≥ 60 mL/min
• ALT and AST ≤ 2.5 x ULN
• Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN in patients with Gilbert syndrome)
• Baseline pulse oximetry > 90% on room air
• Not pregnant or nursing; fertile patients must use effective contraception during and for 4 months after completion of study treatment
• No evidence of immune dysfunction
• No concurrent continuous tricyclic antidepressant therapy
• No medical condition that would preclude study participation
• No chronic hepatitis B or C infection
• No hypersensitivity reaction, history of allergy, or history of untoward reaction to yeast-based products
• Negative for yeast-allergy skin test

---

Study Outline:

• Patients receive recombinant yeast CEA-vaccine subcutaneously at 4 injection sites on Days 1, 15, 29, 43, 57, 71 and 85 and then every 28 days
• Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity
• Patients in the extension phase undergo apheresis for immunologic testing on Days 1, 85, and 169

---

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: 9/8/09
Updated: 7/27/09