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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00023933
First received: September 13, 2001
Last updated: January 24, 2013
Last verified: January 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immune response [ Time Frame: Up to 54 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
Investigators
Principal Investigator: Ruby Meredith University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00023933     History of Changes
Other Study ID Numbers: NCI-2012-02406, UAB 9846, CDR0000068877
Study First Received: September 13, 2001
Last Updated: January 24, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rectal Neoplasms
Colonic Neoplasms
Adenocarcinoma
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014