Status:
COMPLETED
Vaccine Therapy in Treating Patients With Liver or Lung Metastases From Colorectal Cancer
Lead Sponsor:
Michael Morse, MD
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
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 c...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00103142
Start Date
February 1 2005
End Date
March 1 2013
Last Update
October 14 2015
Active Locations (6)
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1
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
2
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
3
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
4
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157