Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Metastatic Colorectal Cancer
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Recurrent Colon Cancer
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Colon
Eligibility Criteria
Inclusion Criteria: Histologically confirmed metastatic adenocarcinoma of the colon or rectum Not amenable to surgical resection Recurrent or persistent disease after standard surgery, radiotherapy, and chemotherapy, including fluorouracil and irinotecan TAG-72 positive Performance status - ECOG 0-2 WBC greater than 3,500/mm^3 Platelet count greater than 125,000/mm^3 Hemoglobin greater than 10 g/dL No nucleated RBC or significant teardrop RBC morphology Bilirubin less than 1.5 mg/dL SGOT/SGPT less than 4 times normal Hepatitis B surface antigen negative Creatinine less than 2.0 mg/dL HIV negative No other malignancy within the past 5 years except basal cell skin cancer No allergy to iodine No detectable antibody to monoclonal antibody CC49 Not pregnant or nursing Fertile patients must use effective contraception At least 3 weeks since prior immunotherapy and recovered No prior bone marrow or stem cell transplantation No other concurrent immunotherapy See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered No concurrent chemotherapy See Disease Characteristics At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to more than 25% of red marrow No concurrent radiotherapy See Disease Characteristics At least 3 weeks since prior surgery and recovered
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Experimental
Treatment (monoclonal antibody)
Patients receive a tracer dose of iodine I 131 monoclonal antibody CC49-deltaCH2 IV on day 1 and a therapy dose over 30 minutes on day 8. Cohorts of 3-5 patients receive escalating doses of iodine I 131 monoclonal antibody CC49-deltaCH2 until the MTD is determined. The MTD is defined as the dose at which 3 of 5 patients experience grade 3 or greater toxicity while 0-2 of 5 patients experience reversible grade 4 hematologic toxicity.