At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed adenocarcinoma of colorectal, breast, ovarian, or non-colorectal origin with CEA or MUC-1 expression (≥20% by immunohistochemistry or serum CEA >5 µg/L), except ovarian and breast which presumed to express these markers.
- ✓Prior treatment: colorectal cancer patients must have completed ≥1 5-FU-containing chemotherapy regimen; non-colorectal, breast, and ovarian cancer patients must have failed or be ineligible for therapy of proven efficacy.
- ✓Age ≥18 years.
- ✓HLA-A2 positivity required for all colorectal adenocarcinoma patients and at least 10 non-colorectal adenocarcinoma patients; not required for breast or ovarian cohorts.
- ✕HIV positivity or other evidence of immunocompromise.
- ✕Active autoimmune disease requiring treatment or history of autoimmune disease that might be stimulated by vaccine (except controlled endocrine disease, thyroid disease, adrenal disease, or vitiligo).
- ✕Current systemic corticosteroids except physiologic replacement doses or topical/nasal/inhaled preparations; limited IV contrast allergy prophylaxis allowed.
- ✕History of allergy or adverse reaction to prior vaccinia vaccination.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label Pilot Study to Evaluate the Safety and Tolerability of PANVAC-V (Vaccinia) and PANVAC-F (Fowlpox) in Combination With Sargramostim in Adults With Metastatic Carcinoma
In Brief
A Phase 2 clinical trial evaluating PANVAC-V, PANVAC-F, and 1 other intervention for Adenocarcinoma and 3 related conditions. Completed, enrolled 51 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Patients receive 2 x 10(8) pfu PANVAC-V (vaccinia) subcutaneously on Day 1.
Patients receive 1 x 10(9) pfu PANVAC-F (fowlpox) or about days 15, 29, and 43 then every month for 12 doses then every 3 months until disease progression or toxicity.
100g sargramostim will be given subcutaneously at the site of the vaccination on each vaccination day and for three consecutive days thereafter.