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

Sponsored by:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00102024

Purpose

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	Intervention	Phase
Colorectal Cancer Metastases	Drug: Unconjugated IDEC-159 Drug: 111In-IDEC-159 Drug: 90Y-IDEC-159	Phase I Phase II

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Immunoglobulins Globulin, Immune IDEC 159

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
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

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	30
Study Start Date:	January 2005
Estimated Study Completion Date:	July 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102024

Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300

Sponsors and Collaborators

Biogen Idec

Investigators

Principal Investigator:

Andres Forero, M.D.

Comprehensive Cancer Center, University of Alabama at Birmingham

More Information

Study ID Numbers:	159-01
Study First Received:	January 19, 2005
Last Updated:	June 7, 2006
ClinicalTrials.gov Identifier:	NCT00102024
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biogen Idec:

Metastatic Colorectal Adenocarcinoma
Anti TAG-72
Monoclonal Antibody

Study placed in the following topic categories:

Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Carcinoma
Antibodies, Monoclonal

Antibodies
Digestive System Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Adenocarcinoma
Colorectal Neoplasms
Immunoglobulins
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site

Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009