Safety and Activity of 90Y-Labeled IDEC-159 in Subjects With Metastatic Colorectal Adenocarcinoma

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. Identifier: NCT00102024
Recruitment Status : Terminated
First Posted : January 20, 2005
Last Update Posted : August 27, 2010
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Brief Summary:
This is a Phase I/II open-label, dose-escalating study in patients with metastatic colorectal cancer. The objectives of the study are to obtain information on the safety of radiolabeled IDEC-159, as well as its activity in colorectal cancer. Another objective is to determine the maximum tolerated dose (MTD). The study duration is 2 years with visits occuring daily and/or weekly for the first 3 months, and every 6 weeks until the end of the 2 year period.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastases Drug: Unconjugated IDEC-159 Drug: 111In-IDEC-159 Drug: 90Y-IDEC-159 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, Open-Label, Dose-Escalation Study to Evaluate the Safety and Activity of Single Dose 90Y-Labeled IDEC-159, Humanized, Domain Deleted, Anti TAG-72 Monoclonal Antibody, in Subjects With Metastatic Colorectal Adenocarcinoma
Study Start Date : January 2005
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

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Primary Outcome Measures :
  1. To characterize the safety profile and determine the MTD of 90Y-IDEC-159 in subjects with metastatic colorectal cancer.

Secondary Outcome Measures :
  1. To evaluate activity; blood, normal organ, and tumor dosimetry; the immunogenicity and pharmacokinetics of 90Y-IDEC-159; and its effect on soluble TAG-72 (sTAG-72) levels.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Sign an Institutional Review Board (IRB)-approved informed consent.
  • Metastatic colorectal adenocarcinoma that has been pathologically confirmed following failed response or relapse while on or following fluoropyrimidine, irinotecan, and oxaliplatin chemotherapy. (Prior therapy with cetuximab is recommended if the tumors are epidermal growth factor receptor [EGFR] positive.)
  • Age 18 or above.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
  • Recovered to baseline toxicity from any significant toxicity associated with prior surgery, chemotherapy, biological therapy, or investigational drug.
  • Adequate bone marrow reserve (absolute neutrophil count > 1500 cells/mm3, platelet count > 125,000 cells/mm3, hemoglobin concentration ≥ 10 g/dL).
  • Radiographically measurable disease (RECIST criteria).
  • Life expectancy of at least 3 months.
  • Male and female subjects of reproductive potential must agree to follow accepted birth control methods, as determined by the investigator, during treatment and for 12 months after completion of treatment.

Exclusion Criteria:

  • Prior radioimmunotherapy.
  • Known presence of central nervous system (CNS) metastasis.
  • Any lesion > 7.5 cm.
  • Total bilirubin > 2.0 mg/dL.
  • Total creatinine > 2.0 mg/dL.
  • AST and ALT > 2.5 times upper limit of normal (ULN), if metastases to the liver > 5 times ULN.
  • Presence of a second primary malignancy requiring active treatment (except for hormonal therapy).
  • Serious non-malignant disease or infection that, in the opinion of either the investigator or sponsor, would compromise protocol objectives.
  • History of external beam radiation therapy to > 25% of active bone marrow.
  • History of bone marrow or stem cell transplant.
  • History of granulocyte colony-stimulating factor (G-CSF) or granulocyte macrophage colony stimulating factor (GM-CSF) therapy within 2 weeks before Study Day 1.
  • History of pegylated G-CSF therapy within 4 weeks before Study Day 1.
  • History of major surgery, other than diagnostic surgery, within 4 weeks of Study Day 1.
  • History of receiving investigational product within 4 weeks before Study Day 1 or long term toxicity from a previous investigational therapy.
  • Known history of HIV or AIDS.
  • Concurrent systemic corticosteroid therapy or other immunosuppressive agents, unless for the treatment of computed tomography (CT) dye allergy reactions.
  • Pregnant or lactating female.

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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 identifier (NCT number): NCT00102024

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
Sponsors and Collaborators
Principal Investigator: Andres Forero, M.D. Comprehensive Cancer Center, University of Alabama at Birmingham

Responsible Party: Study MD, Biogen Idec Identifier: NCT00102024     History of Changes
Other Study ID Numbers: 159-01
First Posted: January 20, 2005    Key Record Dates
Last Update Posted: August 27, 2010
Last Verified: August 2010

Keywords provided by Biogen:
Metastatic Colorectal Adenocarcinoma
Anti TAG-72
Monoclonal Antibody

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