Status:
UNKNOWN
Bispecific Antibody in Finding Tumor Cells in Patients With Colorectal Cancer
Lead Sponsor:
Garden State Cancer Center at the Center for Molecular Medicine and Immunology
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Diagnostic procedures, such as radionuclide imaging using bispecific antibody, may help find colorectal cancer cells and learn the extent of disease. PURPOSE: This phase I trial is studyin...
Detailed Description
OBJECTIVES: * Assess the pharmacokinetics and tissue distribution of anti-CEA x anti-HSG bispecific monoclonal antibody TF2 in patients with colorectal cancer. OUTLINE: This is a multicenter study. ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed colorectal cancer
- Radiological documentation of disease is preferred, but not required
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Life expectancy ≥ 3 months
- WBC ≥ 3,000/mm³
- Neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Serum creatinine normal
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST/ALT \< 2 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 1 month after completion of study therapy
- No medical conditions that might prevent full participation in protocol-required testing or follow-up
- No institutionalized patients (e.g., in prisons or mental health institutions)
- PRIOR CONCURRENT THERAPY:
- No concurrent chemotherapy or treatments that would compromise the safety and efficacy of protocol assessments
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00895323
Start Date
November 1 2008
Last Update
September 17 2013
Active Locations (1)
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1
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007