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

NCT00102024 | Terminated Phase 1

• 1 other identifier: 159-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Metastases

Keywords

Metastatic Colorectal Adenocarcinoma; Anti TAG-72; Monoclonal Antibody

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (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.

Interventions

Unconjugated IDEC-159 DRUG

111In-IDEC-159 DRUG

90Y-IDEC-159 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3300, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andres Forero, M.D.

  Comprehensive Cancer Center, University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 19, 2005
• First Posted: January 20, 2005
• Study Start: January 1, 2005
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: August 27, 2010

Record last verified: 2010-08

Locations

US (1)