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Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00023933
First Posted: June 20, 2003
Last Update Posted: January 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  Purpose
Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have recurrent or persistent metastatic colorectal cancer. Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Radiolabeled monoclonal antibody therapy may be effective treatment for colorectal cancer

Condition Intervention Phase
Adenocarcinoma of the Colon Adenocarcinoma of the Rectum Recurrent Colon Cancer Recurrent Rectal Cancer Stage IV Colon Cancer Stage IV Rectal Cancer Drug: iodine I 131 monoclonal antibody CC49-deltaCH2 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of 131I-HuCC49^CH2 for Colon Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose of 131I-HuCC49^CH2 based on dose-limiting toxicities [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Immune response [ Time Frame: Up to 54 weeks ]

Enrollment: 15
Study Start Date: October 2001
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (monoclonal antibody)

Patients receive a tracer dose of iodine I 131 monoclonal antibody CC49-deltaCH2 IV on day 1 and a therapy dose over 30 minutes on day 8.

Cohorts of 3-5 patients receive escalating doses of iodine I 131 monoclonal antibody CC49-deltaCH2 until the MTD is determined. The MTD is defined as the dose at which 3 of 5 patients experience grade 3 or greater toxicity while 0-2 of 5 patients experience reversible grade 4 hematologic toxicity.

Drug: iodine I 131 monoclonal antibody CC49-deltaCH2
Given IV
Other Names:
  • 131I-HuCC49-deltaCH2
  • 131I-MOAB CC49-deltaCH2

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose of iodine I 131 monoclonal antibody CC49-deltaCH2 (deleted CH2 region) in patients with colorectal cancer.

II. Determine the toxic effects, plasma pharmacokinetics, whole body biodistribution, and conjugate stability of this drug in these patients.

III. Determine the ability of this drug to localize to tumor sites in these patients.

IV. Determine the immune response in patients treated with this drug.

OUTLINE: This is a dose-escalation study.

Patients receive a tracer dose of iodine I 131 monoclonal antibody CC49-deltaCH2 IV on day 1 and a therapy dose over 30 minutes on day 8.

Cohorts of 3-5 patients receive escalating doses of iodine I 131 monoclonal antibody CC49-deltaCH2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 3 of 5 patients experience grade 3 or greater toxicity while 0-2 of 5 patients experience reversible grade 4 hematologic toxicity.

Patients are followed weekly for a minimum of 7 weeks and then every 6 weeks until disease progression.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed metastatic adenocarcinoma of the colon or rectum

    • Not amenable to surgical resection
    • Recurrent or persistent disease after standard surgery, radiotherapy, and chemotherapy, including fluorouracil and irinotecan
  • TAG-72 positive
  • Performance status - ECOG 0-2
  • WBC greater than 3,500/mm^3
  • Platelet count greater than 125,000/mm^3
  • Hemoglobin greater than 10 g/dL
  • No nucleated RBC or significant teardrop RBC morphology
  • Bilirubin less than 1.5 mg/dL
  • SGOT/SGPT less than 4 times normal
  • Hepatitis B surface antigen negative
  • Creatinine less than 2.0 mg/dL
  • HIV negative
  • No other malignancy within the past 5 years except basal cell skin cancer
  • No allergy to iodine
  • No detectable antibody to monoclonal antibody CC49
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • At least 3 weeks since prior immunotherapy and recovered
  • No prior bone marrow or stem cell transplantation
  • No other concurrent immunotherapy
  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy and recovered
  • No concurrent chemotherapy
  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to more than 25% of red marrow
  • No concurrent radiotherapy
  • See Disease Characteristics
  • At least 3 weeks since prior surgery and recovered
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00023933


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ruby Meredith University of Alabama at Birmingham
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00023933     History of Changes
Other Study ID Numbers: NCI-2012-02406
UAB 9846
CDR0000068877 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: September 13, 2001
First Posted: June 20, 2003
Last Update Posted: January 25, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Adenocarcinoma
Rectal Neoplasms
Colonic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Iodine
Immunologic Factors
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances