Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed 20 and over MSKCC-90143 NCI-V91-0004

Objectives

I.  Determine limiting radiation-induced toxicities of 131I-labeled monoclonal 
antibody A33 (131I-MOAB A33) in patients with advanced colorectal cancer.

II.  Determine the maximum radiation dosage of 131I-MOAB A33 to tumor 
achievable with limited toxicity to normal tissues.

III.  Determine retention of 131I-MOAB A33 in tumor and normal tissue over a 4 
week period.

Entry Criteria

Disease Characteristics:

Histologically confirmed, advanced unresectable colorectal
adenocarcinoma

Refractory to or patient has refused conventional
chemotherapy

Disease measurable or evaluable by conventional imaging
(e.g., radiographs, ultrasound, CT) required

No CNS involvement

Prior/Concurrent Therapy:

Biologic therapy:
  No prior administration of murine monoclonal antibody or
  fragment

  No positive HAMA titer

  Excellent radiolocalization of 131I-MOAB A33 in a
  diagnostic study, with or without a positive HAMA, may
  permit entry, at the discretion of the investigator

  At least 6 weeks since prior immunotherapy

Chemotherapy:
  At least 6 weeks since prior chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior radiotherapy

Surgery:
  Not specified

Other:
  No concurrent requirement for steroids or other
  anti-inflammatory agents

Patient Characteristics:

Age:
  20 and over

Performance status:
  Karnofsky 70-100%

Life expectancy:
  At least 6 weeks

Hematopoietic:
  WBC greater than 3,500
  Platelets greater than 100,000

Hepatic:
  Bilirubin less than 2 mg/dl
  PT less than 1.3 x control

Renal:
  Creatinine less than 2 mg/dl

Cardiovascular:
  No significant cardiac disease (NYHA class III/IV)

Other:
  No serious infection requiring antibiotics
  No other serious illness
  No pregnant or lactating women

Expected Enrollment

A total of 21 patients (3 at each dose) will be required.

Outline

Nonrandomized study.

Radioimmunotherapy.  Iodine-131-Labeled Monoclonal Antibody A33, 131I-MOAB A33.

Welt S, Divgi CR, Kemeny N, et al.: Phase I/II study of iodine 131-labeled monoclonal antibody A33 in patients with advanced colon cancer. J Clin Oncol 12(8): 1561-1571, 1994.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Sydney Welt, MD, Protocol chair(Contact information may not be current)		Ph: 570-882-2787; 800-525-2225 Email: welt_sydney@guthrie.org