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Radio-labeled Antibody for Colorectal Cancer

N/A

Waitlist Available

Led By Neeta Pandit-Taskar, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The following laboratory results within the last 2 weeks prior to study day 1: Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, Platelet count ≥ 75 x 10^9/L, Serum bilirubin ≤ 2.5 mg/dL, Serum creatinine ≤ 2.0 mg/dL, White Blood Count (WBC) ≥ 3,000/mm^3, Age ≥ 18 years. Children of all ages are not included as colon cancer is extremely rare in children

Primary or metastatic colorectal carcinoma, histologically confirmed at Memorial Sloan-Kettering Cancer Center (MSKCC)

Must not have

Clinically significant cardiac disease (New York Heart Association Class III/IV)

Previous treatment with A33 or its fragment and/or a positive test for huA33 HAHA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a new drug can help safely detect colorectal cancer.

Who is the study for?

This trial is for adults with confirmed colorectal cancer who are fit enough for surgery/biopsy and have adequate organ function. They must not be pregnant, breastfeeding, or have heart disease, active brain tumors, or prior A33 treatment.

What is being tested?

The study tests if a drug called 124I-huA33 can safely identify colorectal cancer in patients. It involves using a radioactive antibody to detect the presence of cancer cells.

What are the potential side effects?

Potential side effects may include reactions related to the immune system due to the introduction of antibodies and issues from radioactivity exposure such as nausea or changes in blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My colorectal cancer was confirmed at MSKCC.

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I am eligible for surgery or biopsy for my colorectal cancer.

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I am mostly able to care for myself and carry out daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe heart disease.

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I have been treated with A33 or tested positive for huA33 HAHA.

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I am not pregnant or breast-feeding.

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My cancer has spread to my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Radio-labeled huA33 AntibodyExperimental Treatment1 Intervention

Patients will receive a single I-V infusion of 4mCi-10mCi/10mg 124I-huA33 in 5-30 mL of 5% human serum albumin (HAS) in normal saline, over 5 minutes-4 hours. Patients will be studied with 124I-huA33 positron-emission tomography (PET) and ex-vivo quantitation of tumor uptake . Blood samples will be obtained for pharmacokinetic analysis at 5, 15, 60, and 120 minutes after completion of IV, on and before or after PET scanning on subsequent days. Surgery (or biopsy) will be scheduled to occur 8- 10 days after administration of 124I-huA33. The 8-10 day imaging session will be scheduled for the morning of surgery or biopsy, approximately 1-6 hours before the procedure.

0 / 8Eligibility criteria met