Expired Study
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Bethesda, Maryland 20892


Purpose:

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.


Criteria:

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


NCT ID:

NCT00085241


Primary Contact:

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


Backup Contact:

N/A


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: June 25, 2018

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