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Phase I Study of Humanized Monoclonal Antibody A33 in Advanced Colorectal Carcinoma (Summary Last Modified 07/95)

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

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase I

Treatment

Closed

over 18

NCI

MSKCC-94100
NCI-H95-0616

Objectives

I.  Evaluate the toxicity of humanized monoclonal antibody A33 (HuA33) in 
patients with advanced colorectal cancer.

II.  Assess the pharmacokinetics of and patient immune response to 
intravenously administered HuA33.

III.  Assess whether serum HuA33 at prescribed doses is high enough to lyse 
human colon cancer target cells in vitro by antibody-dependent cellular 
cytotoxicity.

IV.  Assess whether complement is activated or depleted in blood by HuA33.

Entry Criteria

Disease Characteristics:


Histologically proven colorectal cancer
  Unresectable Stage III/IV that has failed standard therapy

Disease measurable or evaluable by radiograph, ultrasound, CT, or other
imaging methods

No CNS involvement by tumor

Prior/Concurrent Therapy:


No prior mouse monoclonal antibody or fragment unless:
  Human anti-mouse antibody (HAMA) negative

At least 4 weeks since chemotherapy, radiotherapy, or immunotherapy

Patient Characteristics:


Age:
  Over 18

Performance status:
  Karnofsky 70-100%

Life expectancy:
  At least 6 weeks

Hematopoietic:
  AGC greater than 1,500
  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 NYHA class III/IV status

Other:
  No serious infection requiring antibiotics
  No requirement for steroids or other anti-inflammatory agents
  No other serious illness
  No pregnant or nursing women

Expected Enrollment

Up to 24 patients will be entered over 8 months.

Outline

Biological Response Modifier Therapy.  Humanized Monoclonal Antibody A33, 
HuA33.

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

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.