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Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Colorectal Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Colorectal Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Colorectal Cancer Clinical research trials and Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Colorectal Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Colorectal Cancer. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Colorectal Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Colorectal Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Colorectal Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Colorectal Cancer  Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Colorectal Cancer
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Colorectal Cancer
For Condition: recurrent rectal cancer,adenocarcinoma of the rectum,recurrent colon cancer,adenocarcinoma of the colon,stage 4 colon cancer,Stage 4 rectal cancer
Status: Suspended
Sponsor(s): National Cancer Institute (NCI) , UAB Comprehensive Cancer Center
Synopsis: RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Radiolabeled monoclonal antibody therapy may be effective treatment for colorectal cancer. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have recurrent or persistent colorectal cancer.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of iodine I 131 monoclonal antibody CC49 deltaCH2 (deleted CH2 region) in patients with colorectal cancer. II. Determine the toxic effects, plasma pharmacokinetics, whole body biodistribution, and conjugate stability of this drug in these patients. III. Determine the ability of this drug to localize to tumor sites in these patients. IV. Determine the immune response in these patients treated with this drug. PROTOCOL OUTLINE: This is a dose-escalation study. Patients receive iodine I 131 monoclonal antibody CC49 deltaCH2 IV over 30 minutes on day 1. Cohorts of 3-5 patients receive escalating doses of iodine I 131 monoclonal antibody CC49 deltaCH2 until the maximum tolerated dose (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. Patients are followed weekly for a minimum of 7 weeks and then every 6 weeks until disease progression. PROJECTED ACCRUAL: Approximately 3-15 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 19 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed metastatic adenocarcinoma of the colon or rectum - Not amenable to surgical resection - Recurrent or persistent following standard surgery, radiotherapy, and chemotherapy, including fluorouracil and irinotecan - TAG-72 positive --Prior/Concurrent Therapy-- Biologic therapy: - At least 3 weeks since prior immunotherapy and recovered - No prior bone marrow or stem cell transplantation - No other concurrent immunotherapy Chemotherapy: - See Disease Characteristics - At least 3 weeks since prior chemotherapy and recovered - No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: - 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 Surgery: - See Disease Characteristics - At least 3 weeks since prior surgery and recovered --Patient Characteristics-- Age: 19 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: - WBC greater than 3,500/mm3 - Platelet count greater than 125,000/mm3 - Hemoglobin greater than 10 g/dL - No nucleated RBC or significant teardrop RBC morphology Hepatic: - Bilirubin less than 1.5 mg/dL - SGOT/SGPT less than 4 times normal - Hepatitis B surface antigen negative Renal: Creatinine less than 2.0 mg/dL Other: - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RubyMeredith, Study Chair, UAB Comprehensive Cancer Center
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Additional Information:
Study ID Numbers: CDR0000068877; NCI-1313,UAB-9846
Study Start Date: October 2001
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00023933
Other Stage 4 Colon Cancer Studies:
1. Biological Therapy and Chemotherapy in Treating Patients With Metastatic Kidney Cancer or Colorectal Cancer
2. Gene Therapy in Patients With Colon Cancer That Has Spread to the Liver
3. Neoadjuvant and Adjuvant Capecitabine and Oxaliplatin in Treating Patients With Resectable Liver Metastases Secondary to Colorectal Cancer
4. Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer
5. BMS-247550 in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Related Studies:
Other stage 4 colon cancer Clinical Trials
Other Alabama Clinical Trials
Other Birmingham Clinical Trials
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Colorectal Cancer
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