Colorectal Cancer
Conditions
Keywords
stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
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 studying how well a bispecific antibody works in finding tumor cells in patients with colorectal cancer.
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. 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 radioactivity measurements.
Interventions
OTHERenzyme-linked immunosorbent assay
OTHERpharmacological study
PROCEDUREwhole-body scintigraphy
RADIATIONiodine I 131-labeled anti-CEA/anti-HSG bispecific monoclonal antibody TF2
Sponsors
Garden State Cancer Center at the Center for Molecular Medicine and Immunology
Study design
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | — |
| Tissue distribution | — |
Countries
United States
Outcome results
None listed