Bispecific Antibody in Finding Tumor Cells in Patients With Colorectal Cancer
Launched by GARDEN STATE CANCER CENTER AT THE CENTER FOR MOLECULAR MEDICINE AND IMMUNOLOGY · May 7, 2009
Trial Information
Current as of May 20, 2025
Unknown status
Keywords
ClinConnect Summary
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.
Patients receive iodine I 131-labeled anti-CEA x anti-HSG bispecific monoclonal antibody TF2 (\^131I-TF2) IV over 10-20 minutes on day 1. Patients also undergo whole-body external scintigraphy at various times during the study.
Blood samples are collected at baseline and periodically after \^131I-TF2 infusion for pharmacokinetic studies and \^131I-TF2 biodistribution by ELISA and radioactivit...
Gender
ALL
Eligibility criteria
- 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
About Garden State Cancer Center At The Center For Molecular Medicine And Immunology
Garden State Cancer Center, in collaboration with the Center for Molecular Medicine and Immunology, is dedicated to advancing cancer research and treatment through innovative clinical trials. With a focus on molecular and immunological approaches, the center aims to enhance patient outcomes by developing targeted therapies and personalized medicine strategies. By integrating cutting-edge scientific research with patient care, Garden State Cancer Center fosters a collaborative environment that prioritizes safety, efficacy, and the ethical conduct of clinical trials, ultimately striving to improve the quality of life for cancer patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Washington, District Of Columbia, United States
Patients applied
Trial Officials
Aiwu R. He, MD
Principal Investigator
Lombardi Comprehensive Cancer Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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