ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Metastatic Colorectal Cancer

This study has been completed.

Sponsors and Collaborators: Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00023933
  Purpose

RATIONALE: 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.

PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have recurrent or persistent metastatic colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: iodine I 131 monoclonal antibody CC49-deltaCH2
Phase I

MedlinePlus related topics:   Cancer    Colorectal Cancer   

Drug Information available for:   Iodine    Cadexomer iodine    Sodium iodide I 131   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase I Trial of 131I-HuCC49^CH2 for Colon Cancer

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

Primary Outcome Measures:
  • Maximum tolerated dose at week 6 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immune response at weeks 1, 3, 6, 18, 30, 42, and 54 [ Designated as safety issue: No ]

Study Start Date:   October 2001

Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of iodine I 131 monoclonal antibody CC49-deltaCH2 (deleted CH2 region) in patients with colorectal cancer.
  • Determine the toxic effects, plasma pharmacokinetics, whole body biodistribution, and conjugate stability of this drug in these patients.
  • Determine the ability of this drug to localize to tumor sites in these patients.
  • 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.

PROJECTED ACCRUAL: Approximately 3-15 patients will be accrued for this study.

  Eligibility
Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 19 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • 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

Hepatic:

  • Bilirubin less than 1.5 mg/dL
  • SGOT/SGPT less than 4 times normal
  • Hepatitis B surface antigen negative

Renal:

  • Creatinine less than 2.0 mg/dL

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 3 weeks since prior immunotherapy and recovered
  • No prior bone marrow or stem cell transplantation
  • No other concurrent immunotherapy

Chemotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy and recovered
  • No concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • 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

Surgery:

  • See Disease Characteristics
  • At least 3 weeks since prior surgery and recovered
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023933

Locations
United States, Alabama
Comprehensive Cancer Center at University of Alabama at Birmingham    
      Birmingham, Alabama, United States, 35294-3300

Sponsors and Collaborators
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
National Cancer Institute (NCI)

Investigators
Study Chair:     Ruby F. Meredith, MD, PhD     Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   CDR0000068877, UAB-9846, NCI-1313
First Received:   September 13, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00023933
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer  
stage IV rectal cancer  
recurrent colon cancer  
recurrent rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum

Study placed in the following topic categories:
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Recurrence
Intestinal Neoplasms
Antibodies, Monoclonal
Antibodies
Digestive System Diseases
Gastrointestinal Neoplasms
Iodine
Adenocarcinoma
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




Links to all studies - primarily for crawlers