- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00103142
Vaccine Therapy in Treating Patients With Liver or Lung Metastases From Colorectal Cancer
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
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.
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
District of Columbia
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Washington, District of Columbia, United States, 20007
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
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Florida
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Tampa, Florida, United States, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Baptist Medical Center
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Oregon
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Portland, Oregon, United States, 97213-2967
- Providence Cancer Center at Providence Portland Medical Center
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South Carolina
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Charleston, South Carolina, United States, 29425
- Hollings Cancer Center at Medical University of South Carolina
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Given subcutaneously and intradermally
Given subcutaneously and intradermally
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.
|
Given subcutaneously
Given subcutaneously and intradermally
Given subcutaneously and intradermally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
13 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplastic Processes
- Colorectal Neoplasms
- Neoplasm Metastasis
- Physiological Effects of Drugs
- Immunologic Factors
- Sargramostim
Other Study ID Numbers
- Pro00007616
- DUMC-5883-04-6RO (Other Identifier: Legacy Duke IRB Number)
- CDR000041079 (Other Identifier: NCI)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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