RATIONALE: Flt3L may stimulate a person's immune system and help kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of flt3L given to patients before
undergoing surgery to remove metastases from colorectal cancer.
OBJECTIVES: I. Evaluate the safety and feasibility of administering flt3 ligand to patients
with hepatic metastases from colorectal cancer prior to surgical resection.
OUTLINE: Patients receive flt3 ligand subcutaneously for 14 days followed by 14 days of
rest. This course of therapy may be repeated for a total of 3 courses. Leukapheresis is
performed on day 15 of the last course of Flt3 ligand. Patients undergo restaging and
metastasis resection. Patients are followed every 3 months for the first year, every 6
months for the second year, and yearly thereafter.
PROJECTED ACCRUAL: This study will accrue 12 patients in 1 year.
DISEASE CHARACTERISTICS: Histologically confirmed metastatic colon cancer expressing
carcinoembryonic antigen (CEA) At least 50% of tumor cells must express CEA with at least
moderate intensity Resectable hepatic metastases or other site of metastatic colon cancer
that is resectable (e.g., lung metastases)
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: At least 6 months Hematopoietic: Absolute neutrophil count at least 1000/mm3
Absolute lymphocyte count at least 1000/mm3 Hemoglobin at least 9 mg/dL Platelet count at
least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL No hepatic disease Renal:
Creatinine less than 2.5 mg/dL Cardiovascular: No ongoing cardiac disease No New York
Heart Association class III or IV heart disease Pulmonary: No ongoing pulmonary disease
such as: Asthma Chronic obstructive pulmonary disease (COPD) Active radiation- or
drug-induced pneumonitis Other: Not pregnant or nursing Fertile patients must use
effective contraception No history of autoimmune disease such as but not limited to:
Inflammatory bowel disease Systemic lupus erythematosus Ankylosing spondylitis Scleroderma
Type I diabetes Multiple sclerosis No other serious ongoing chronic or acute illness No
medical or psychological impediment to study compliance No concurrent or prior second
malignancy except: Nonmelanoma skin cancer Controlled superficial bladder cancer within
the last 5 years No active or chronic infection including: Urinary tract infection HIV
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No
concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids No concurrent
hormone therapy Radiotherapy: No concurrent radiation therapy Surgery: No specified Other:
No immunosuppressives such as: Azathioprine Cyclosporine A