Safety Study of Radio-Labeled huA33 Antibody in Colorectal Cancer - Tabular View

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Safety Study of Radio-Labeled huA33 Antibody in Colorectal Cancer

This study is currently recruiting participants.

Study NCT00199862. Last updated on August 7, 2008. Information provided by Ludwig Institute for Cancer Research

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Safety Study of Radio-Labeled huA33 Antibody in Colorectal Cancer

Official Title ^†

A Pilot Study of Radioimmunodetection of 124-Iodine-Labeled Humanized A33 Antibody (124I-huA33) in Patients With Colorectal Cancer

Brief Summary

The purpose of this study is to determine whether our drug, 124I-huA33, can safely detect colorectal cancer.

Detailed Description

This is an open-label, pilot study of a single 4mCi-10mCi/10mg IV dose of 124I-huA33 in patients with colorectal cancer. Patients will be studied with 124I-huA33 positron-emission tomography (PET), and in the subset of patients scheduled for surgery, based on clinical indications, ex vivo quantitation of tumor uptake will also be performed. Patients will receive a single intravenous or intraarterial infusion of 4 mCi-10mCi /10mg 124I-huA33 in 5-30ml of 5% human serum albumin (HSA), over 5-10 minutes. Patient will either receive the 124I-huA33 intravenously (IV) or intraarterially (IA) to determine if there is an advantage of the IV vs the IA route. Following injection with 124I-huA33, on study days 2, 3, and/ or 4, patients will have the option to receive up to 2g/1kg of Immune Globulin (IVIG).

Blood samples will be obtained for pharmacokinetic analysis at 5, 15, 60, and 120 minutes after completion of IV or IA infusion, on day 2, 3, and/ or 4, and before and after the PET scan on the day of surgery or last imaging day (day 8 + 3). Patients scheduled for surgery will undergo a PET scan of the abdomen and pelvis 1-6 hours prior to surgery.

In those patients undergoing surgery, surgery (or biopsy) will be scheduled to occur day 8 (± 3 days) days after administration of 124I-huA33. Biopsy sites may include tumor, tumor bed, regional nodes, portal, suprapancreatic, celiac nodes and the retroperitoneum. Tumor and normal tissue obtained at surgery (or biopsy), and serum will be measured for estimation of percent-injected dose per gram of tumor, normal liver, and serum. Tissue samples will be obtained for autoradiography and immunohistochemistry as an additional assessment of tumor targeting.

Blood samples to determine immunogenicity will be taken at baseline and at 4 weeks.

Toxicity assessments will be made throughout the study period.

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Primary Outcome Measure ^†

To determine and quantify tumor uptake of radiolabeled antibody from measurements with: [ Time Frame: Until end of study ] [ Designated as safety issue: No ]
PET imaging/Dosimetry [ Time Frame: Until end of study ] [ Designated as safety issue: No ]
Autoradiographs - tumor or biopsy samples [ Time Frame: Until end of study ] [ Designated as safety issue: No ]
Ex vivo radioactivity estimates - tumor, normal tissue and serum samples [ Time Frame: Until end of study ] [ Designated as safety issue: No ]
Toxicity defined by NCI Common Toxicity Criteria [ Time Frame: Until end of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measure ^†

Serum radioactivity, volume of distribution, and half-life following IV and IA 124I-huA33 [ Time Frame: Until end of study ] [ Designated as safety issue: No ]
HAHA levels - measured by plasmon resonance surface (Biacore®) assay [ Time Frame: Until end of study ] [ Designated as safety issue: No ]

Condition ^†

Colorectal Neoplasms
Colorectal Cancer
Colorectal Tumor
Colorectal Carcinoma

Intervention ^†

Drug: Iodine-124 labeled humanized A33 (antibody)

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

Start Date ^†

February 2004

Completion Date

June 2009

Eligibility Criteria ^†

Inclusion Criteria:

primary metastatic colorectal carcinoma
candidate for clinically indicated surgery/biopsy
expected survival of at least 3 months
Karnofsky performance status >70 (ECOG0 or 1)
Age 18 or older
women of childbearing potential with confirmed negative pregnancy test
Laboratory results within 2 weeks of study day 1 that show acceptable hematological levels.

Exclusion Criteria:

clinically significant cardiac disease
Active CNS tumor involvement
Previous treatment with A33 or its fragment and/or positive test for huA33 human anti-human antibodies
women who are pregnant or breast-feeding
participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Christine E Pierre, BA

212-693-7246

pierrec@mskcc.org

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00199862

Organization ID

LUD2001-011

Secondary IDs ^††

Study Sponsor ^†

Ludwig Institute for Cancer Research

Collaborators ^††

Memorial Sloan-Kettering Cancer Center

Investigators ^†

Principal Investigator:

Steven M Larson, MD

Memorial Sloan-Kettering Cancer Center

Information Provided By

Ludwig Institute for Cancer Research

Verification Date

August 2008

First Received Date ^†

September 13, 2005

Last Updated Date

August 7, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.