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Immunotherapy

Immunotherapy + Radiation for Cancer

Phase 1

Recruiting

Led By Jeffrey Y Wong

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 should have unresectable disease or not be a candidate for surgical resection

Patients should have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Must not have

Electrolyte disturbances that are not correctable to at least CTCAE grade 1 with replacement therapy

Patients with active brain metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies a combination of radiation therapy and immunocytokine therapy to treat unresectable colorectal & CEA+ breast cancers.

Who is the study for?

This trial is for adults with metastatic colorectal or CEA positive breast cancer that's not operable. Participants must have stable health, an expected survival of at least 3 months, and meet specific blood count and organ function criteria. They should be past certain waiting periods after previous treatments and agree to use effective contraception if applicable.

What is being tested?

The trial tests M5A-IL2 immunocytokine combined with stereotactic body radiation therapy (SBRT) to treat unresectable metastatic cancers. It aims to find the safest dose and see how well it works by targeting cancer cells while activating the immune system.

What are the potential side effects?

Potential side effects include typical reactions from immunotherapy such as flu-like symptoms, fatigue, possible inflammation in various organs due to immune response activation, as well as skin reactions or other localized effects from radiation therapy.

Eligibility Criteria

Inclusion Criteria

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

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My condition cannot be treated with surgery.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer produces CEA above 5 ng/ml or has shown CEA presence through a special test.

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My cancer in the colon, rectum, or breast is confirmed and has spread.

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My doctor thinks I have at least 3 months to live.

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I am 18 years old or older.

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My kidney function is within normal limits.

Exclusion Criteria

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

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My electrolyte levels cannot be corrected to a mild condition.

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I have active cancer spread to my brain.

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I am of child-bearing age and do not use birth control.

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I am on high-dose steroids or other drugs that weaken my immune system.

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I have a wound or surgical cut that has not fully healed.

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I do not have any uncontrolled illnesses or active infections.

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I do not have any other active cancers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum tolerated dose (MTD) of the M5A-IL2 immunocytokine (M5A-ICK)

Recommended phase 2 dose

Secondary study objectives

Incidence of adverse events

Number of participants with treatment-related auto-antibody formation

Pharmacokinetics of M5A-IL2 (M5A-ICK blood clearance )

+1 more

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: Treatment (SBRT, M5A-IL2 ICK)Experimental Treatment8 Interventions

Patients undergo SOC SBRT over 3 fractions on days 1, 3, and 5, followed by M5A-ICK SC on days 8, 9, and 10 once daily for a single cycle on study. Patients undergo CT or PET/CT as well as blood sample collection throughout the trial. Patients may undergo magnetic resonance imaging or bone scan as clinically indicated on the trial. Additionally, patients may optionally undergo tissue biopsy during screening and on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~790