Phase 2
N=73
Vaccine Therapy in Treating Patients With Liver or Lung Metastases From Colorectal Cancer
Colorectal Cancer · Metastatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00103142 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Recurrence-free Survival at 2 Years — 13; 10 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- falimarev (Biological); inalimarev (Biological); sargramostim (Biological); therapeutic autologous dendritic cells (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Michael Morse, MD
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recurrence-free Survival at 2 Years |
13; 10 | — |
| SECONDARY Positive Immune Response as Measured by (Enzyme-linked Immunosorbent Spot) ELISpot Assay |
9; 4 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT00103142). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.