Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed locally advanced or metastatic colorectal cancer Metastatic disease must be radiologically proven HLA-A2-1 positive Locally advanced disease must have had prior resection or incomplete resection with poor prognosis Locally advanced disease includes: Stage III or IV colon cancer (T4 or any T, N2-3, M0) Stage III or IV rectal cancer (T4 or T3, N1-3) Resectable or unresectable T4 disease after radiotherapy, chemotherapy, and/or surgery Absence of measurable disease but more than a 50% chance of recurrence Completely resected or locally advanced disease may have had conventional therapy completed within 1-12 months (surgery alone, with or without adjuvant chemotherapy and/or radiotherapy) prior to study entry Metastatic disease patients must have bidimensionally measurable disease Bone lesions with well-demarcated borders allowed Lesions seen only on bone scan, pleural effusions, ascites, and changes in carcinoembryonic antigen are not considered measurable disease PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Lymphocyte count at least 470/mm^3 Granulocyte count at least 1,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 2.0 mg/dL* SGOT no greater than 4 times upper limit of normal (ULN) (2.5 times ULN for adjuvant patients)* Albumin at least 3 g/dL No active viral hepatitis No evidence of chronic infection due to hepatitis C Hepatitis B surface antigen negative NOTE: *Unless due to metastatic disease Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No history of cardiac failure, significant arrhythmias, or coronary artery disease (metastatic disease patients only) Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative No prior malignancy with a 50% chance of recurrence within 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix No medical or psychiatric condition that would preclude compliance No serious medical condition that would preclude apheresis No serious infection No uncontrolled thyroid disease (metastatic disease patients only) Patients with an allergy to eggs are allowed but are not vaccinated against influenza during study PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunologic therapy directed at the cellular immune system Chemotherapy: See Disease Characteristics Prior chemotherapy for metastatic disease allowed At least 4 weeks since prior chemotherapy No concurrent chemotherapy or anticipated need for chemotherapy for 2 months after vaccinations Endocrine therapy: At least 4 weeks since prior supraphysiologic steroid therapy Radiotherapy: See Disease Characteristics Prior radiotherapy for metastatic disease allowed No concurrent radiotherapy Surgery: See Disease Characteristics Prior surgery for metastatic disease allowed
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
- Vanderbilt-Ingram Cancer Center