Colon Cancer Clinical Trial
Vaccine Therapy in Treating Patients With Liver or Lung Metastases From Colorectal Cancer
Summary
RATIONALE: Vaccines made from a gene-modified virus and a person's white blood cells may make the body build an effective immune response to kill tumor cells. Biological therapies, such as Granulocyte-macrophage colony-stimulating factor (GM-CSF), may stimulate the immune system in different ways and stop tumor cells from growing. Combining different types of biological therapies may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying giving vaccine therapy together with dendritic cells to see how well it works compared to giving vaccine therapy together with GM-CSF in treating patients with liver or lung metastases from colorectal cancer removed by surgery.
Full Description
OBJECTIVES:
Primary
Compare 2-year disease-free survival of patients with completely resected hepatic or pulmonary metastases secondary to colorectal cancer treated with adjuvant vaccine therapy comprising vaccinia-Carcinoembryonic antigen (CEA)-mucin 1 (MUC-1)- Triad of costimulatory molecules TRICOM vaccine (PANVAC-V) and fowlpox-CEA-MUC-1-TRICOM vaccine (PANVAC-F) administered with autologous dendritic cells or with sargramostim (GM-CSF).
Secondary
Compare the rate and magnitude of immune response, as determined by enzyme-linked immunosorbent spot (ELISpot), in patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine subcutaneously (SC) and intradermally (ID) on days 28, 56, and 84.
Arm II: Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
After completion of study treatment, patients are followed for 2 years.
PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for this study within 2 years.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed hepatic or pulmonary metastases secondary to adenocarcinoma of the colon and rectum
Must have undergone complete resection of hepatic or pulmonary metastases with curative intent
No evidence of gross residual disease after surgery
One or more resected and ablated lesions allowed provided all gross residual tumor was destroyed by ablation
Repeated resections of hepatic metastatic disease or resections of extrahepatic metastases prior to resection of the hepatic metastases allowed provided the most recent hepatic metastatic resection included total disease resection and/or ablation
Must have received at least 2 months of perioperative systemic chemotherapy (including preoperative and/or postoperative chemotherapy) that was completed at least 1 month ago
PATIENT CHARACTERISTICS:
Age
At least 18
Performance status
Karnofsky 70-100%
Life expectancy
At least 6 months
Hematopoietic
Platelet count ≥ 75,000/mm^3
Hemoglobin ≥ 8.5 g/dL (transfusion or epoetin alfa allowed)
Hepatic
Bilirubin ≤ 2.0 mg/dL
Hepatitis B surface antigen negative
Hepatitis C antibody negative
No other serious chronic or acute hepatic disease
Renal
Creatinine ≤ 1.5 mg/dL OR
Creatinine clearance > 60 mL/min
Cardiovascular
No New York Heart Association class III or IV cardiac disease
No other serious chronic or acute cardiac disease
Pulmonary
No asthma
No chronic obstructive pulmonary disease
No other serious chronic or acute pulmonary disease
Immunologic
No history of autoimmune disease, including, but not limited to, any of the following:
Inflammatory bowel disease
Systemic lupus erythematosus
Ankylosing spondylitis
Scleroderma
Multiple sclerosis
No human immunodeficiency virus (HIV) infection by enzyme-linked immunosorbent assay (ELISA) and western blot
Not immunocompromised (by disease or therapy)
No allergy to eggs or any component of the study vaccine
No history of allergy or untoward reaction to prior vaccinia (smallpox) vaccination
No allergy or untoward reaction to sargramostim (GM-CSF)
No active acute or chronic infection, including urinary tract infection within the past 72 hours
No inflammatory bowel conditions, including, but not limited to, the following:
Active infectious enteritis
Eosinophilic enteritis
No acute, chronic, or exfoliative skin disorders, including any of the following:
Extensive psoriasis
Burns
Impetigo
Disseminated zoster
Varicella zoster
Severe acne
Other open rashes or wounds
Other
Not pregnant or nursing
Fertile patients must use effective contraception
Able to avoid close contact or household contact for 3 weeks after each vaccination with the following individuals:
Children under 5 years of age
Pregnant or nursing women
Individuals with prior or concurrent extensive eczema, other eczematoid skin disorders, or other acute or chronic skin conditions
Immunosuppressed or immunodeficient individuals
No medical or psychological condition that would preclude study compliance
No extensive eczema
No other serious chronic or acute illness that would preclude study participation
No other malignancy within the past 5 years except nonmelanoma skin cancer, controlled superficial bladder cancer, or previously treated carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
No other concurrent immunotherapy
Chemotherapy
See Disease Characteristics
No concurrent chemotherapy
Endocrine therapy
More than 6 weeks since prior and no concurrent steroid therapy
Radiotherapy
No concurrent radiotherapy
Surgery
See Disease Characteristics
Other
No other concurrent immunosuppressants (e.g., azathioprine or cyclosporine)
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 6 Locations for this study
Washington District of Columbia, 20007, United States
Tampa Florida, 33612, United States
Durham North Carolina, 27710, United States
Winston-Salem North Carolina, 27157, United States
Portland Oregon, 97213, United States
Charleston South Carolina, 29425, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.