PANVAC-V and PANVAC-F Vaccines Plus Sargramostim to Treat Advanced Cancer

Completed · Phase 1/Phase 2

Conditions studied: Adenocarcinoma, Colorectal Cancer, Ovarian Cancer, Breast Cancer

In brief

Background: * Many cancers produce two proteins, carcinoembryonic antigen (CEA) and mucin-1 (MUC-1). * The PANVAC-V (PANVAC vaccinia) priming vaccine and PANVAC-F (PANVAC fowlpox) boosting vaccine contain human genes that cause production of CEA and MUC-1, which can be used as a target for the immune system to attack the cancer. The vaccines also contain genes that cause production of other proteins that enhance immune activity. * Sargramostim is a protein that boosts the immune system. Objectives: * To evaluate the safety and effectiveness of PANVAC-V and PANVAC-F in patients with advanced cancer. * To document the immune response to the vaccines and any anti-tumor responses that may occur. Eligibility: Patients 18 years of age and older with advanced cancer whose tumors produce CEA or MUC-1 protein Design: * This trial has three cohorts: the first cohort includes 10 patients with advanced colorectal cancer and 10 to 15 patients with any advanced non-colorectal cancer that produces either EA or mitochondrial Ca2+ uniporter 1 (MCU-1); the second cohort includes 12 patients with advanced breast cancer and the third cohort includes 14 patients with advanced ovarian cancer. * All patients receive PANVAC-V on study day 1, followed by PANVAC-F 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. The vaccines are given by injection under the skin. Sargramostim is injected at the vaccination site on the day of each vaccination and for the next 3 days following vaccination. * Patients whose scans show that their disease has progressed, but who are otherwise clinically stable may revert back to monthly injections. * Patients undergo apheresis to collect white blood cells (lymphocytes) on day 1 and day 71 of the study to measure the immune response to the treatment. Blood is collected through a needle placed in one arm and directed through a cell separator machine where the lymphocytes are extracted. The rest of the blood components are returned to the patient through the same needle. * Patients are monitored with frequent blood tests and periodic imaging tests (scans) to monitor for safety and the response to treatment.

Key facts

Study ID

NCT00088413

Run by

National Cancer Institute (NCI)

People needed

51

Starts

2004-07-21

Expected to finish

2018-05-31

Last updated by the study team

2019-04-16

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• A. Patients should have no evidence of being immunocompromised as listed below.
• Human immunodeficiency virus positivity due to the potential for decreased tolerance and risk for severe side effects
• Active autoimmune diseases requiring treatment or a history of autoimmune disease that might be stimulated by vaccine treatment. This requirement is due to the potential risks of exacerbating autoimmunity. Patients with endocrine disease that is controlled by replacement therapy including thyroid disease and adrenal disease and vitiligo may be enrolled.
• B. Concurrent use of systemic steroids, except for physiologic doses for systemic steroid replacement or local (topical, nasal, or inhaled) steroid use. Limited doses systemic steroids to prevent intravenous (IV) contrast, allergic reaction, or anaphylaxis (in patients who have known contrast allergies) are allowed.
• C. History of allergy or untoward reaction to prior vaccination with vaccinia virus.
• D. Pregnant or breast-feeding women.
• E. Altered immune function, including immunodeficiency or history of immunodeficiency; eczema; history of eczema, or other eczematoid skin disorders; or those with acute, chronic or exfoliative skin conditions (e.g. atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds).
• F. Serious intercurrent medical illness which would interfere with the ability of the patient to carry out the treatment program, including, but not limited to, inflammatory bowel disease, Crohn's disease, ulcerative colitis, or active diverticulitis
• G. Patients with a history of cardiomyopathy or symptomatic congestive heart failure (unless stable on treatment), symptomatic arrhythmia not controlled by medication. Unstable atherosclerotic heart disease (e.g. unstable angina) who require active intervention and history of myocardial infarction or embolic stroke within the past 6 months.
• H. Clinically active brain metastasis, or a history of encephalitis, multiple sclerosis, or seizures within the last year (from seizure disorder or brain metastasis).
• I. Medical conditions, which, in the opinion of the investigators would jeopardize the patient or the integrity of the data obtained.
• J. Concurrent chemotherapy; an exception to this is to allow for patients with breast cancer who are receiving trastuzumab, to continue therapy with trastuzumab while receiving the vaccine treatment.
• K. Serious hypersensitivity reaction to egg products.
• L. Clinically significant cardiomyopathy requiring treatment.
• M. Chronic hepatitis infection, including B and C, because of potential immune impairment.
• N. Although topical steroids are allowed, steroid eye drop are contraindicated.
• O. Cardiac complications, including recent myocardial infarction or cerebrovascular accident within one year, and/or unstable or uncontrolled angina.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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