Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

September 13, 2001
January 24, 2013
October 2001
July 2005   (final data collection date for primary outcome measure)
Maximum tolerated dose of 131I-HuCC49^CH2 based on dose-limiting toxicities [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00023933 on ClinicalTrials.gov Archive Site
Immune response [ Time Frame: Up to 54 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Metastatic Colorectal Cancer
Phase I Trial of 131I-HuCC49^CH2 for Colon Cancer

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

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
Given IV
Other Names:
  • 131I-HuCC49-deltaCH2
  • 131I-MOAB CC49-deltaCH2
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.

Intervention: Drug: iodine I 131 monoclonal antibody CC49-deltaCH2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
Not Provided
July 2005   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00023933
NCI-2012-02406, UAB 9846, CDR0000068877
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Ruby Meredith University of Alabama at Birmingham
National Cancer Institute (NCI)
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP