Expired Study
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Durham, North Carolina 27705


RATIONALE: Vaccines made from a person's white blood cells mixed with peptides may make the body build an immune response to kill cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with refractory stage IV cancer.

Study summary:

OBJECTIVES: - Determine the safety and feasibility of administering 1 or 2 courses of vaccination with carcinoembryonic antigen peptide 1-6D (CAP 1-6D)- and CMV pp65 peptide-pulsed autologous dendritic cells in patients with refractory stage IV CEA-expressing malignancies. - Determine the ability of this regimen to induce CAP 1-6D- and CMV pp65-specific T cells in these patients. - Determine the antitumor effect of this regimen, in terms of progression-free survival, of these patients. OUTLINE: This is an open-label, dose-escalation study. Patients undergo leukapheresis and collection of peripheral blood mononuclear cells from which dendritic cells (DC) are generated and pulsed with carcinoembryonic antigen peptide 1-6D (CAP 1-6D) and CMV pp65 peptide. Patients are assigned to 1 of 2 vaccination cohorts. - Cohort I: Patients receive vaccination with CAP 1-6D-pulsed DC and CMV pp65 peptide-pulsed DC subcutaneously and intradermally every 3 weeks for a total of 4 vaccinations. - Cohort II: Patients receive vaccinations as in cohort I every 3 weeks for a total of 8 vaccinations. For both cohorts, a safe dose of the vaccine is defined as the dose at which no more than 1 of 6 patients experiences unacceptable toxicity. Patients are followed every 3 months for 1 year. PROJECTED ACCRUAL: A total of 12 patients (6 per cohort) will be accrued for this study within 24 months.


DISEASE CHARACTERISTICS: - Histologically confirmed malignancy that is refractory to standard therapy known to have a survival benefit - Stage IV disease - Carcinoembryonic antigen (CEA)-expressing tumor, as evidenced by 1 of the following: - Immunohistochemistry with at least 50% of the tumor with at least moderate intensity of staining - Peripheral blood CEA greater than 2.5 mg/dL - Tumor known to be universally CEA positive (i.e., colon or rectal cancer) - HLA-A201 positive - Measurable disease* - At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan NOTE: *Histologic or cytologic confirmation is not required for measurable disease restricted to a solitary lesion - Received at least 1 prior standard chemotherapy regimen known to have a survival benefit - Previously resected brain metastases allowed provided CT scan or MRI was performed within the past month and shows no metastasis PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% Life expectancy - More than 6 months Hematopoietic - WBC at least 3,000/mm^3 - Hemoglobin at least 9 g/dL (transfusions or red blood cell growth factors [e.g., epoetin alfa] allowed) - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin less than 2.0 mg/dL (unless patient has Gilbert's disease) - SGOT/SGPT less than 1.5 times upper limit of normal - No hepatic disease that would preclude study participation - No viral hepatitis (including chronic hepatitis) by hepatitis B surface antigen and hepatitis C serology Renal - Creatinine less than 2.5 mg/dL - No urinary tract infection Cardiovascular - No New York Heart Association class III or IV heart disease Immunologic - No history of autoimmune disease, including any of the following: - Inflammatory bowel disease - Systemic lupus erythematosus - Ankylosing spondylitis - Scleroderma - Multiple sclerosis - No active acute or chronic infection - HIV negative Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other serious chronic or acute illness that would preclude study participation - No medical or psychological impediment that would preclude study compliance - No other malignancy within the past 5 years except nonmelanoma skin cancer, controlled carcinoma in situ of the cervix, or controlled superficial bladder cancer - No allergy to study vaccine components PRIOR CONCURRENT THERAPY: Biologic therapy - At least 4 weeks since prior immunotherapy - No other concurrent immunotherapy Chemotherapy - See Disease Characteristics - At least 4 weeks since prior chemotherapy - No concurrent chemotherapy Endocrine therapy - At least 6 weeks since prior steroid therapy (except steroids administered as premedication for chemotherapy or contrast-enhanced studies) - Concurrent hormonal therapy allowed for patients with breast cancer - No concurrent steroid therapy Radiotherapy - At least 4 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - Recovered from prior therapy - At least 4 weeks since prior investigational therapy - At least 4 weeks since other prior therapy - Any number of prior therapies are allowed - Concurrent bisphosphonates allowed for bone metastases - No concurrent immunosuppressive therapy (e.g., azathioprine or cyclosporine) - No other concurrent experimental therapies



Primary Contact:

Study Chair
Herbert K. Lyerly, MD
Duke Cancer Institute

Backup Contact:


Location Contact:

Durham, North Carolina 27705
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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