|Phase II||Biomarker/Laboratory analysis, Treatment||Completed||18 and over||NCI||Pro00007616|
DUMC-5883-04-6RO, CDR000041079, 8087, NCT00103142
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 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.
Further Study Information
- 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-CEA-MUC-1-TRICOM vaccine (PANVAC-V) and fowlpox-CEA-MUC-1-TRICOM vaccine (PANVAC-F) administered with autologous dendritic cells or with sargramostim (GM-CSF).
- Compare the rate and magnitude of immune response, as determined by 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 SC and 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.
- 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
- At least 18
- Karnofsky 70-100%
- At least 6 months
- Platelet count ≥ 75,000/mm^3
- Hemoglobin ≥ 8.5 g/dL (transfusion or epoetin alfa allowed)
- Bilirubin ≤ 2.0 mg/dL
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative
- No other serious chronic or acute hepatic disease
- Creatinine ≤ 1.5 mg/dL OR
- Creatinine clearance > 60 mL/min
- No New York Heart Association class III or IV cardiac disease
- No other serious chronic or acute cardiac disease
- No asthma
- No chronic obstructive pulmonary disease
- No other serious chronic or acute pulmonary disease
- No history of autoimmune disease, including, but not limited to, any of the following:
- Inflammatory bowel disease
- Systemic lupus erythematosus
- Ankylosing spondylitis
- Multiple sclerosis
- No HIV infection by 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
- Disseminated zoster
- Varicella zoster
- Severe acne
- Other open rashes or wounds
- 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:
- No other concurrent immunotherapy
- See Disease Characteristics
- No concurrent chemotherapy
- More than 6 weeks since prior and no concurrent steroid therapy
- No concurrent radiotherapy
- See Disease Characteristics
- No other concurrent immunosuppressants (e.g., azathioprine or cyclosporine)
Trial Lead Organizations/Sponsors
Michael Morse, MDNational Cancer Institute
|Michael A. Morse||Study Chair|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00103142
ClinicalTrials.gov processed this data on November 20, 2013
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