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Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Metastatic Colorectal Cancer
This study has been completed.
Study NCT00023933   Information provided by National Cancer Institute (NCI)
First Received: September 13, 2001   Last Updated: May 30, 2009   History of Changes

September 13, 2001
May 30, 2009
October 2001
 
Maximum tolerated dose at week 6 [ Designated as safety issue: Yes ]
Maximum tolerated dose at week 6
Complete list of historical versions of study NCT00023933 on ClinicalTrials.gov Archive Site
Immune response at weeks 1, 3, 6, 18, 30, 42, and 54 [ Designated as safety issue: No ]
Immune response at weeks 1, 3, 6, 18, 30, 42, and 54
 
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Metastatic Colorectal Cancer
Phase I Trial of 131I-HuCC49^CH2 for Colon Cancer

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.

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.

Phase I
Interventional
Treatment
Colorectal Cancer
Other: iodine I 131 monoclonal antibody CC49-deltaCH2
 
Forero A, Meredith RF, Khazaeli MB, Carpenter DM, Shen S, Thornton J, Schlom J, LoBuglio AF. A novel monoclonal antibody design for radioimmunotherapy. Cancer Biother Radiopharm. 2003 Oct;18(5):751-9.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00023933
 
CDR0000068877, UAB-9846, NCI-1313
University of Alabama at Birmingham
National Cancer Institute (NCI)
Study Chair: Ruby F. Meredith, MD, PhD University of Alabama at Birmingham
National Cancer Institute (NCI)
September 2005

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