Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Bethesda, Maryland 20892


RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining vaccine therapy and radiation therapy may kill more tumor cells. PURPOSE: This clinical trial is studying how well giving vaccine therapy together with radiation therapy works in treating patients with carcinoembryonic antigen-positive solid tumors that have metastasized to the liver.

Study summary:

OBJECTIVES: Primary - Determine the clinical safety of vaccinia-CEA-TRICOM vaccine, fowlpox-CEA-TRICOM vaccine, recombinant fowlpox GM-CSF vaccine, and radiotherapy in patients with carcinoembryonic antigen (CEA)-positive solid tumors metastatic to the liver. Secondary - Determine the clinical response in patients receiving this regimen. - Determine the immunological response, specifically the CEA-specific T-cell response, in patients receiving this regimen. - Determine the effect of radiotherapy (before and after treatment) on FAS, major histocompatability complex, p53, and CEA in these patients. OUTLINE: Patients receive a priming vaccination of vaccinia (rV)-CEA-TRICOM and recombinant fowlpox GM-CSF (rF-GM-CSF) vaccine subcutaneously (SC) on day 1. Patients receive a booster vaccination of fowlpox (rF)-CEA-TRICOM and rF-GM-CSF SC on days 21, 35, 49, and 63. Patients undergo radiotherapy on days 22-25, 36-39, 50-53, and 64-67. Patients with stable disease or objective response after day 91 continue to receive rF-CEA-TRICOM and rF-GM-CSF SC every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed annually for 15 years. PROJECTED ACCRUAL: A total of 16 patients will be accrued for this study.


DISEASE CHARACTERISTICS: - Diagnosis of solid tumor - Radiographically visible metastatic liver lesions that are life-threatening - Carcinoembryonic antigen (CEA)-positive disease that meets one of the following criteria: - ≥ 20% of cells stained immunohistochemically - Elevated serum CEA (> 5 ng/mL) at any time during disease course - Received at least 1 prior chemotherapy regimen for metastatic disease - Vaccinia-naïve OR vaccinia-immune - No known brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - At least 6 months Hematopoietic - Granulocyte count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 8 g/dL - Absolute lymphocyte count ≥ 400/mm^3 Hepatic - See Disease Characteristics - AST ≤ 2 times upper limit of normal - Bilirubin normal (≤ 3 times ULN with Gilbert's syndrome) - PT and PTT normal - Hepatitis B and C negative - No chronic liver disease, including the following: - End stage cirrhosis - Chronic active hepatitis by surface antigen or core antibody test Renal - Creatinine normal OR - Creatinine clearance ≥ 60 mL/min Cardiovascular - No New York Heart Association class II-IV heart disease - No evidence of congestive heart failure by physical exam or imaging - No clinically significant cardiomyopathy requiring treatment Pulmonary - No pulmonary disease with fatigue or dyspnea after ordinary physical activity Immunological - No autoimmune disease, including the following: - Addison's disease - Hashimoto's thyroiditis - Systemic lupus erythematous - Sjögren syndrome - Scleroderma - Myasthenia gravis - Goodpasture syndrome - Active Grave's disease - HIV negative - No allergy or untoward reaction to prior vaccination with vaccinia virus or to any component of the vaccinia vaccine regimen - No serious hypersensitivity reaction to egg products Other - During and for at least 3 weeks after vaccinia vaccination, patients or their close household contacts must not have contact with the following individuals: - Individuals with active or a history of eczema or other eczematoid skin disorders - Individuals with acute, chronic, or exfoliative skin disorders, including any of the following until the condition resolves: - Atopic dermatitis - Burns - Impetigo - Varicella zoster - Severe acne - Other open rashes or wounds - Pregnant or nursing women - Children ≤ 5 years of age - Individuals who are immunodeficient or immunosuppressed by disease or therapy (including HIV-infected individuals) - No concurrent serious medical illness that would preclude study compliance, including, but not limited to, the following: - Inflammatory bowel disease - Crohn's disease - Ulcerative colitis - Active diverticulitis - No history of seizures, encephalitis, or multiple sclerosis - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 4 months after study treatment PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - Prior immunotherapy allowed - No other concurrent immunotherapy Chemotherapy - See Disease Characteristics - More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - No concurrent chemotherapy Endocrine therapy - No concurrent systemic steroids except physiologic doses for systemic steroid replacement or local (topical, nasal, or inhaled) steroids - At least 2 weeks since prior steroid eye drops - No concurrent steroid eye drops during and for 4 weeks after vaccinia vaccination - No concurrent hormone therapy - No concurrent dexamethasone or other steroid as an antiemetic Radiotherapy - No prior radiotherapy to > 50% of all nodal groups - No prior radiotherapy to the whole liver - No other concurrent radiotherapy Surgery - No prior splenectomy - No concurrent major surgery Other - Recovered from all prior therapy - At least 4 weeks since prior cytotoxic therapy - No concurrent aprepitant - No other concurrent anticancer therapy



Primary Contact:

Principal Investigator
James L. Gulley, MD, PhD, FACP
National Cancer Institute (NCI)

Backup Contact:


Location Contact:

Bethesda, Maryland 20892
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.