Vaccine Therapy in Treating Patients With Liver or Lung Metastases From Colorectal Cancer
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ClinicalTrials.gov Identifier: NCT00103142 |
Recruitment Status :
Completed
First Posted : February 8, 2005
Results First Posted : April 7, 2014
Last Update Posted : October 14, 2015
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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.
Condition or disease | Intervention/treatment | Phase |
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Colorectal Cancer Metastatic Cancer | Biological: falimarev Biological: inalimarev Biological: sargramostim Biological: therapeutic autologous dendritic cells | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 74 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study of Active Immunotherapy With PANVAC or Autologous, Cultured Dendritic Cells Infected With PANVAC After Complete Resection of Hepatic or Pulmonary Metastases of Colorectal Carcinoma |
Study Start Date : | February 2005 |
Actual Primary Completion Date : | June 2009 |
Actual Study Completion Date : | March 2013 |
Arm | Intervention/treatment |
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Experimental: PANVAC-V + PANVAC-F + DC
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 SC and ID on days 28, 56, and 84.
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Biological: falimarev
Given subcutaneously and intradermally Biological: inalimarev Given subcutaneously and intradermally Biological: therapeutic autologous dendritic cells Given subcutaneously and intradermally |
Experimental: PANVAC-V + PANVAC-F + GM-CSF
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.
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Biological: falimarev
Given subcutaneously and intradermally Biological: inalimarev Given subcutaneously and intradermally Biological: sargramostim Given subcutaneously |
- Recurrence-free Survival at 2 Years [ Time Frame: 2 years ]Recurrence-free survival for randomized patients receiving dendritic cells (DC) loaded with PANVAC or PANVAC plus Granulocyte-macrophage colony-stimulating factor (GM-CSF) measured from the date of metastasectomy, with relapse defined as documented disease recurrence at any site.
- Positive Immune Response as Measured by (Enzyme-linked Immunosorbent Spot) ELISpot Assay [ Time Frame: 13 weeks ]CEA-Specific Immune Responders by enzyme-linked immunosorbent spot (ELISpot). The ELISPOT assay is considered positive for a subject if the mean number of spots with CEA exceeds the number of spots with control by a magnitude of 10 and the difference between CEA and control is statistically significant at a level of p=0.05 by the t-test.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed hepatic or pulmonary metastases secondary to adenocarcinoma of the colon and rectum
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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
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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
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No inflammatory bowel conditions, including, but not limited to, the following:
- Active infectious enteritis
- Eosinophilic enteritis
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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
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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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00103142
United States, District of Columbia | |
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | |
Washington, District of Columbia, United States, 20007 | |
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |
Tampa, Florida, United States, 33612-9497 | |
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 | |
Wake Forest University Baptist Medical Center | |
Winston-Salem, North Carolina, United States, 27157 | |
United States, Oregon | |
Providence Cancer Center at Providence Portland Medical Center | |
Portland, Oregon, United States, 97213-2967 | |
United States, South Carolina | |
Hollings Cancer Center at Medical University of South Carolina | |
Charleston, South Carolina, United States, 29425 |
Study Chair: | Michael A. Morse, MD | Duke Cancer Institute |
Responsible Party: | Michael Morse, MD, Professor of Medicine, Duke University |
ClinicalTrials.gov Identifier: | NCT00103142 |
Other Study ID Numbers: |
Pro00007616 DUMC-5883-04-6RO ( Other Identifier: Legacy Duke IRB Number ) CDR000041079 ( Other Identifier: NCI ) |
First Posted: | February 8, 2005 Key Record Dates |
Results First Posted: | April 7, 2014 |
Last Update Posted: | October 14, 2015 |
Last Verified: | October 2015 |
liver metastases adenocarcinoma of the colon recurrent colon cancer stage IV colon cancer |
adenocarcinoma of the rectum recurrent rectal cancer stage IV rectal cancer lung metastases |
Colorectal Neoplasms Neoplasm Metastasis Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Colonic Diseases Intestinal Diseases Rectal Diseases Neoplastic Processes Pathologic Processes Sargramostim Immunologic Factors Physiological Effects of Drugs |