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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 13, 2001 | ||||
| Last Updated Date | May 30, 2009 | ||||
| Start Date ICMJE | October 2001 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Maximum tolerated dose at week 6 [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Maximum tolerated dose at week 6 | ||||
| Change History | Complete list of historical versions of study NCT00023933 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Immune response at weeks 1, 3, 6, 18, 30, 42, and 54 [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Immune response at weeks 1, 3, 6, 18, 30, 42, and 54 | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Metastatic Colorectal Cancer | ||||
| Official Title ICMJE | Phase I Trial of 131I-HuCC49^CH2 for Colon Cancer | ||||
| Brief Summary | 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 metastatic colorectal cancer. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a dose-escalation study. 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 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. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Colorectal Cancer | ||||
| Intervention ICMJE | Other: iodine I 131 monoclonal antibody CC49-deltaCH2 | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Forero A, Meredith RF, Khazaeli MB, Carpenter DM, Shen S, Thornton J, Schlom J, LoBuglio AF. A novel monoclonal antibody design for radioimmunotherapy. Cancer Biother Radiopharm. 2003 Oct;18(5):751-9. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Gender | Both | ||||
| Ages | 19 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00023933 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000068877, UAB-9846, NCI-1313 | ||||
| Study Sponsor ICMJE | University of Alabama at Birmingham | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | September 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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