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Phase I Study of Preoperative Detection of Colorectal Carcinoma With Bispecific Antibody Pretargeting


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

Phase I Study of Preoperative Detection of Colorectal Carcinoma With Bispecific Antibody Pretargeting


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Pharmacokinetics

Safety Issue:

No

Principal Investigator

Aiwu R. He, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lombardi Cancer Research Center

Authority:

Unspecified

Study ID:

CDR0000636332

NCT ID:

NCT00895323

Start Date:

November 2008

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • 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
  • Colorectal Neoplasms

Name

Location

Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007