Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
Background: * Carcinoembryonic antigen (CEA) and mucin-1 (MUC-1) are overexpressed in multiple adenocarcinomas. * Pox viral vectors can induce a strong immune response to CEA and MUC-1. * The use of agonist epitopes within the tumor associated antigen (TAA) can induce a better immune response than native peptides and have been associated with clinical responses * Heterologous prime and boost regimens are superior in terms of generalizing immune responses; and this may translate into improved clinical responses * The use of granulocyte-macrophage colony-stimulating factor (GM-CSF) does not add significant toxicity and in pre-clinical models is essential for induction for optimal immune responses. * It is possible by using vectors directed against TAA that there may be additive or synergistic immune responses and this may be important in overcoming antigenic escape variance * Evidence of clinical benefit has been noted in some patients treated with this vaccine Objectives: * For colorectal cancer and non-colorectal cancer Cohort: To evaluate the safety and tolerability of the vaccine. * For the Ovarian Cancer and Breast Cancer Cohorts: To evaluate clinical response to the vaccine. Eligibility: * In the first cohort (colorectal and non-colorectal cancer), histologically confirmed adenocarcinoma that is CEA or MUC-1 positive described as metastatic disease (measurable or evaluable) or metastatic disease documented by biopsy but not evaluable by imaging (e.g. small volume peritoneal disease) * For the ovarian and breast cancer cohorts, patients must have evaluable disease * Normal organ function, Eastern Cooperative Oncology Group (ECOG) 0-1 Design: * This is a non-randomized three cohort, pilot trial of pox viral vaccines that contain the transgenes for CEA and MUC-1 (both with modified human leukocyte antigen A2 (HLA-A2) agonist epitopes) as well as 3 human T-cell costimulatory molecules, B7-1, ICAM-1 (CD54), and LFA-3 (CD58) \[PANVAC(TM)-V (vaccinia) and PANVAC(TM)-F (fowlpox)\] in patients with metastatic carcinoma that express CEA or MUC-1 antigen. * The first cohort will enroll 10 patients with metastatic colorectal adenocarcinoma and 10-15 patients with any metastatic non-colorectal carcinoma that expresses either CEA or MUC-1. . * The second cohort will enroll 12 patients with metastatic breast carcinoma and 14 patients with metastatic ovarian carcinoma. * All patients will receive the same vaccines on the same schedule. PANVAC(TM)-V (vaccinia) subcutaneously (s.c.) scheduled on day 1, followed by PANVAC(TM)-F (fowlpox) s.c. scheduled on days 15, 29, and 43 then every 28 days for up to 12 vaccines followed by every 3 months until disease progression or toxicity. * Sargramostim (100 micro g) will be given at the site of the vaccination (PANVAC-V and PANVAC-F) on each vaccination day and for three consecutive days thereafter. * Patients who have radiographic evidence of progressive disease, but who are otherwise clinically stable may revert back to monthly vaccinations.
Age
18–100
Sex
ALL
Healthy volunteers
Not accepted
