Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer
Adenocarcinoma of the Colon, Adenocarcinoma of the Gallbladder, Adenocarcinoma of the Pancreas
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Colon
Eligibility Criteria
Inclusion Criteria: Histologically confirmed adenocarcinoma that failed standard curative options and for which no standard palliative options are required within the next 8weeks Advanced or metastatic disease Recurrent or unresectable disease Microscopic metastatic disease confirmed by surgical exploration allowed CEA expression by immunohistochemistry Circulating CEA greater than 5 ng/mL HLA phenotyping required HLA phenotyping must be repeated for patients who have undergone allogeneic bone marrow transplantation No clinically symptomatic brain metastases Patients with brain metastases who have completed palliative radiotherapy and have discontinued steroids are eligible Hormone receptor status: Not specified Male or female Performance status - ECOG 0-1 WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Bilirubin less than 1.5 times upper limit of normal (ULN) AST and ALT less than 3 times ULN PT and PTT less than 1.5 times ULN (unless therapeutically anticoagulated) Creatinine less than 1.5 mg/dL Creatinine clearance greater than 60 mL/min Proteinuria or hematuria less than +2 on urinalysis* Urine protein less than 1,000 mg/24-hour collection, if proteinuria greater than +1 No frequent vomiting or severe anorexia No more than 10% weight loss within the past 3 months No inflammatory bowel disease, Crohn's disease, ulcerative colitis, or active diverticulitis No uncontrolled seizure disorders No encephalitis No multiple sclerosis No allergy to eggs No HIV-associated opportunistic infection No autoimmune diseases, including the following: Systemic lupus erythematosus Sjögren's syndrome Scleroderma Myasthenia gravis Goodpasture syndrome Addison's disease Hashimoto's thyroiditis Graves' disease Antinuclear antibody positive status allowed if no evidence of an autoimmune disease No direct contact of vaccination site with the following persons for at least 72 hours after each vaccination: Children under 1 year of age Pregnant women Individuals with eczema or other open skin condition Immunocompromised individuals No other concurrent serious medical illness that would preclude study entry No other malignancy within the past 2 years except excised basal cell or squamous cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for at least 1 month before (female patients only), during, and for at least 3 months after study participation See Disease Characteristics No prior CEA-directed active immunotherapy Prior CEA-directed antibody therapy allowed At least 4 weeks since prior immunotherapy and recovered No other concurrent antineoplastic biologic therapy or immunotherapy At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No concurrent antineoplastic chemotherapy See Disease Characteristics No concurrent antineoplastic hormonal therapy No concurrent systemic steroids (inhaled steroids allowed) Concurrent systemic mineralocorticoids (e.g., megestrol for appetite stimulation or fludrocortisone) allowed Concurrent birth control pills allowed See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to more than 50% of all nodal groups See Disease Characteristics Recovered from prior surgery No prior splenectomy Concurrent non-steroidal anti-inflammatory drugs allowed No other concurrent anti-cancer therapy
Sites / Locations
- Fox Chase Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (vaccine therapy, sargramostim, vaccine adjuvant)
The first three cohorts of 3-12 patients receive escalating doses of recombinant fowlpox-CEA-TRICOM vaccine (fCEA-TRI) until the maximum tolerated dose (MTD) is determined. fCEA-TRI is administered intradermally every 2 weeks for 4 doses and then every 2 months thereafter (beginning on day 56) in the absence of disease progression or unacceptable toxicity. The fourth and fifth cohorts of 6 patients receive fCEA-TRI at the MTD in the same manner as the first three cohorts combined with escalating doses of sargramostim (GM-CSF). GM-CSF is administered subcutaneously once daily beginning on the day of each vaccination and continuing for a total of 4 days. The sixth through eighth cohorts of 6 patients receive fCEA-TRI at the MTD in the same manner as the first three cohorts combined with escalating doses of recombinant fowlpox-GM-CSF (rF-GM-CSF).