What is the mechanism of action of this treatment?

Monoclonal antibodies, such as I-124 M5A, target specific antigens like carcinoembryonic antigen (CEA) on colorectal cancer cells and can be linked to radioactive substances for precise imaging or treatment. This targeted approach allows for accurate detection and destruction of cancer cells while sparing healthy tissue. Other common treatments include chemotherapy, which kills rapidly dividing cells, and immunotherapy, which enhances the immune system's ability to fight cancer. These therapies are vital for colorectal cancer patients as they provide targeted, effective options to manage and potentially eliminate the disease.

What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, particularly those involving monoclonal antibodies like cetuximab, can cause side effects such as infusion-related reactions, skin rashes, and hypomagnesemia. When these therapies are linked to radioactive substances, additional side effects may include fatigue, nausea, and potential long-term risks associated with radiation exposure, such as secondary cancers. Patients should discuss these potential side effects with their healthcare provider to make informed decisions about their treatment options.

What prior FDA approvals exist?

The FDA has approved several monoclonal antibodies for the treatment of colorectal cancer. Notably, cetuximab, an anti-EGFR antibody, has shown efficacy both as a single agent and in combination with irinotecan. Bevacizumab, an anti-VEGF antibody, has improved outcomes when combined with various chemotherapies. Additionally, a pilot study evaluated the use of 131I anti-CEA monoclonal antibody combined with hyperthermia for metastatic colorectal adenocarcinoma, indicating interest in radio-labeled antibodies for targeting CEA-positive cancer cells. These treatments share similarities with the I-124 M5A trial, which uses a monoclonal antibody linked to a radioactive substance for imaging CEA-positive liver metastases.

What other types of research exist?

Promising alternatives to I-124 M5A for imaging CEA-positive colorectal cancer cells include: <ol> <li>F(ab')2 fragments of anti-CEA monoclonal antibody FO23C5 radiolabeled with 131I or 111In, which have been used in large multicenter clinical trials for CEA-expressing tumors.</li> <li></li> </ol> Ga-68 DOTATATE, Ga-68 DOTATOC, and Cu-64 DOTATATE PET/CT, which are highly sensitive somatostatin receptor-targeting radiotracers used for detecting neuroendocrine tumors and could potentially be adapted for colorectal cancer imaging.

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I-124 M5A Imaging for Metastatic Colorectal Cancer

Phase 1

Waitlist Available

Led By Savita V Dandapani

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Patients must have at least 2 known sites of metastatic liver disease. Patients should have at least one resectable liver metastasis as assessed by hepatobiliary surgical oncology

Patients must have histologically confirmed metastatic colorectal cancer with liver metastases. NOTE: We are not requiring proof of CEA positive disease because > 95% of colorectal cancers are CEA positive

Must not have

Pregnant women are excluded from this study. Breastfeeding should be discontinued if the mother is treated with 124I-M5A

Patients with single (= 1) liver metastasis are not eligible for this protocol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Summary

This trial studies how well an imaging agent called I-124 M5A works in detecting colorectal cancer that has spread to the liver. The agent combines an antibody that finds cancer cells with a radioactive signal that makes them visible on scans. It targets patients with a specific type of cancer that may not be easily detected with standard imaging techniques. The M5A antibody has been extensively studied for its effectiveness in targeting colorectal cancer.

Who is the study for?

This trial is for adults with colorectal cancer that has spread to the liver. They must have at least two known liver metastases, one of which can be surgically removed. Participants need recent imaging scans and should not have had any cancer treatments in the last two weeks. Women who can bear children and men must use contraception, and pregnant women are excluded.

What is being tested?

The trial tests I-124 M5A, a radioactive antibody that binds to cancer cells in the liver, using PET scans for detection. It aims to see how well this agent shows up on scans to locate tumors in patients whose colorectal cancer has spread to their livers.

What are the potential side effects?

Potential side effects may include allergic reactions related to the monoclonal antibody or iodine content of I-124 M5A, as well as general risks associated with exposure to radioactivity such as nausea or radiation sickness.

Eligibility Criteria

Inclusion Criteria

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

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I have at least two liver tumors, and one can be surgically removed.

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My colorectal cancer has spread to my liver.

Exclusion Criteria

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

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I am not pregnant and will stop breastfeeding if treated.

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I do not have only one liver metastasis.

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I do not have any uncontrolled illnesses or active infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Tumor targeting pharmacokinetic parameters of iodine I 124 monoclonal antibody M5A

Secondary study objectives

I-124 identification of extra-hepatic lesions (both previously noted or new)

Incidence of adverse events

Surgical pathology results (when available) on lesions positive on I-124 M5A but negative on standard imaging

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (iodine I 124 monoclonal antibody M5A, PET scan)Experimental Treatment2 Interventions

Patients receive iodine I 124 monoclonal antibody M5A IV on day 0 and undergo PET scan on days 2 and 6.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2011

Completed Phase 2

~2200

Iodine I 124 Monoclonal Antibody M5A

2020

Completed Phase 1

~10

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Monoclonal antibodies, such as I-124 M5A, target specific antigens like carcinoembryonic antigen (CEA) on colorectal cancer cells and can be linked to radioactive substances for precise imaging or treatment. This targeted approach allows for accurate detection and destruction of cancer cells while sparing healthy tissue. Other common treatments include chemotherapy, which kills rapidly dividing cells, and immunotherapy, which enhances the immune system's ability to fight cancer. These therapies are vital for colorectal cancer patients as they provide targeted, effective options to manage and potentially eliminate the disease.

Phase I/II trial of combined 131I anti-CEA monoclonal antibody and hyperthermia in patients with advanced colorectal adenocarcinoma.CEA Response and Depth of Response (DpR) to Predict Clinical Outcomes of First-Line Cetuximab Treatment for Metastatic Colorectal Cancer.[Drug therapy of colorectal carcinoma].