Recruiting
Phase 1

Bispecific Antibody

Sponsor:

Garden State Cancer Center at the Center for Molecular Medicine and Immunology

Code:

NCT00895323

Conditions

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

enzyme-linked immunosorbent assay

pharmacological study

whole-body scintigraphy

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

Study Details

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

Study ID

NCT00895323

Start date

Nov, 2008

Status verified date

Jul, 2009

Primary completion date

Mar, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

9 participants

Anticipated

Primary purpose

Diagnostic

Interventions and Outcome Measures

Interventions

enzyme-linked immunosorbent assay

pharmacological study

whole-body scintigraphy

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

Primary outcome measure

  • Pharmacokinetics [ Time Frame: undefined ]
  • Tissue distribution [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Recruiting

Washington, District of Columbia, United States, 20007

Contacts

Clinical Trials Office - Lombardi Comprehensive Cancer Center

202-444-0381

More Information

Sponsor

Garden State Cancer Center at the Center for Molecular Medicine and Immunology

Last update posted

Sep 17, 2013

Last verified

Jul, 2009

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Garden State Cancer Center at the Center for Molecular Medicine and Immunology on 2013-09-17.