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Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer Clinical research trials and Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer clinical trial. Subjects frequently get the best healthcare possible for their Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer  Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer
For Condition: Colon Cancer,Pancreatic Cancer,Esophageal Cancer,Rectal Cancer,Gastric Cancer,Colorectal Cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , UCSF Cancer Center and Cancer Research Institute
Synopsis: RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. This may be an effective treatment for gastrointestinal cancer. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have gastrointestinal cancer.
Details: OBJECTIVES: I. Determine the biodistribution and biokinetics of iodine I 131-labeled monoclonal antibody CC49-delta CH2 in patients with gastrointestinal adenocarcinoma. II. Determine the human anti-human monoclonal antibody response in patients treated with this drug. PROTOCOL OUTLINE: Patients receive iodine I 131-labeled monoclonal antibody CC49-delta CH2 (131I MOAB CC49-delta CH2) IV over 5-10 minutes on day 0. Patients also receive unlabeled monoclonal antibody CC49-delta CH2 IV over 5 minutes followed by 131I MOAB CC49-delta CH2 IV over 5-10 minutes on day 28. Patients are followed weekly for 4 months and then every 3 months for 1 year. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 19 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed adenocarcinoma of the esophagus, stomach, pancreas, colon, or rectum; More than 30% positively immunoreactive to monoclonal antibody CC49 in the metastatic or primary lesion OR TAG-72 antigen serum level greater than 15 - Measurable or evaluable unresectable or metastatic disease by CT scan --Prior/Concurrent Therapy-- - Biologic therapy: No prior murine immunoglobulin - Chemotherapy: Prior or concurrent chemotherapy allowed - Endocrine therapy: Not specified - Radiotherapy: Prior radiotherapy allowed - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: 19 and over - Performance status: ECOG 0-2 - Life expectancy: At least 3 months - Hematopoietic: WBC greater than 3,500/mm3; Platelet count greater than 150,000/mm3; Hemoglobin greater than 10 g/dL - Hepatic: Bilirubin less than 2.0 mg/dL; ALT and AST less than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present); PTT less than 37.0 seconds INR less than 2.0 - Renal: Creatinine less than 2.0 mg/dL - Other: No known allergy to murine immunoglobulin; No iodine allergy; No concurrent illness that would preclude study; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; Must be ambulatory and able to comply with study schedule
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MargaretTempero, Study Chair, UCSF Cancer Center and Cancer Research Institute
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Additional Information:
Study ID Numbers: CDR0000068971; UCSF-00455,UCSF-H11156-18101-02,NCI-T97-0054
Study Start Date: April 2001
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025532
Other Esophageal Cancer Studies:
1. Safety, Efficacy, and Pharmacokinetics Study of Tarceva to Treat Advanced Colorectal Cancer
2. Trial for First-Line Treatment of Colorectal Cancer
3. Local and Systemic Chemotherapy with or without Isolated Liver Perfusion for Patients with Inoperable Metastatic Colorectal Cancers of the Liver
4. A Phase I Study To Test The Safety Of DAVANAT With and Without 5-Fluorouracil In Patients With Solid Tumors
5. Irinotecan Plus Gemcitabine in Treating Patients With Unresectable or Metastatic Solid Tumors
Related Studies:
Other Esophageal Cancer Clinical Trials
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Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer
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