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Phase I Study of 90Y-MOAB CC49 for Unresectable or Metastatic Adenocarcinoma of the Gastrointestinal Tract (Summary Last Modified 03/95)
Basic Trial Information
Objectives I. Correlate the administered dose of yttrium-90-labeled monoclonal antibody CC49 (90Y-MOAB CC49) with predicted absorbed tumor dose in patients with unresectable or metastatic adenocarcinoma of the gastrointestinal tract, using indium-111-labeled monoclonal antibody CC49 for imaging. II. Determine whether absorbed doses of 4,000 cGy of 90Y-MOAB CC49 can be reached in metastatic sites. III. Determine the maximum tolerated dose of 90Y-MOAB CC49. Entry Criteria Disease Characteristics: Histologic diagnosis of gastrointestinal adenocarcinoma not amenable to potentially curable treatment as follows: Gastric: Unresectable or metastatic Failed at least 1 course of a fluorouracil-containing regimen Colorectal: Metastatic Failed at least 1 course of fluorouracil-containing regimen Pancreatic: Unresectable or metastatic No prior therapy required Esophageal: Unresectable Standard radiotherapy with or without chemotherapy required for symptomatic disease prior to entry Greater than 30% reactivity of primary or metastatic tumor cells with MOAB CC49 Serum TAG at least 15 U/ml if MOAB reactivity test not feasible No CNS metastases Prior/Concurrent Therapy: Biologic therapy: No prior murine antibody immunotherapy HAMA negativity required following prior exposure to murine antibody reagent for imaging studies Chemotherapy: At least 4 weeks since chemotherapy See Disease Characteristics for site-specific requirements Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since radiotherapy See Disease Characteristics for esophageal primaries Surgery: Full recovery from prior surgery (usually 4 weeks) required Patient Characteristics: Age: 18 to 65 Performance status: ECOG 0 or 1 Life expectancy: At least 3 months Hematopoietic: WBC greater than 3,500 Platelets greater than 150,000 Hepatic: Bilirubin less than 2.0 mg/dl SGOT no greater than 5 x ULN Alkaline phosphatase no greater than 5 x ULN PT less than 13 seconds PTT less than 37 seconds Renal: Creatinine less than 2.0 mg/dl Other: No serious active medical condition requiring active medical management, including: Infection Diabetes Heart disease Hypertension No mental incompetence No pregnant women Effective contraception required of fertile patients Expected Enrollment 18-36 patients will be entered over 9-12 months. Outline Radioimmunotherapy. Yttrium-labeled Murine Monoclonal Antibody CC49, 90Y-MOAB CC49, NSC-647944. Trial Lead Organizations UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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