Bispecific Antibody in Finding Tumor Cells in Patients With Colorectal Cancer

NCT00895323 | Unknown Phase 1

• 2 other identifiers: CDR0000636332CMMI-C-071A-07
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

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

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics

• Tissue distribution

Interventions

enzyme-linked immunosorbent assay OTHER

pharmacological study OTHER

whole-body scintigraphy PROCEDURE

iodine I 131-labeled anti-CEA/anti-HSG bispecific monoclonal antibody TF2 RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Garden State Cancer Center at the Center for Molecular Medicine and Immunology: lead

Study Sites (1)

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Enzyme-Linked Immunosorbent Assay

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Immunoenzyme Techniques; Immunoassay; Immunologic Techniques; Investigative Techniques; Immunosorbent Techniques; Immunohistochemistry; Molecular Probe Techniques

Study Officials

• Aiwu R. He, MD

  Lombardi Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: DIAGNOSTIC
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 7, 2009
• First Posted: May 8, 2009
• Study Start: November 1, 2008
• Primary Completion: March 1, 2010
• Last Updated: September 17, 2013

Record last verified: 2009-07

Locations

US (1)