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

Biogen1 site in 1 country30 target enrollmentJanuary 2005

ConditionsColorectal Cancer Metastases

DrugsUnconjugated IDEC-159 111In-IDEC-159 90Y-IDEC-159

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Colorectal Cancer
Sponsor: Biogen
Enrollment: 30
Locations: 1
Primary Endpoint: To characterize the safety profile and determine the MTD of 90Y-IDEC-159 in subjects with metastatic colorectal cancer.
Status: Terminated
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2005

End Date

January 2006

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Biogen

Eligibility 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
•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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.