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Checkpoint Inhibitor

Immunotherapy with Steroids for Brain Metastases (ACT-FAST Trial)

Phase 2

Recruiting

Research Sponsored by AHS Cancer Control Alberta

Eligibility Criteria Checklist

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

Must have

Patients with a performance status of ECOG 0-2

Patients with histologically confirmed diagnoses of malignant melanoma, non-small cell lung cancer, renal cell carcinoma, and genitourinary carcinoma not-otherwise specified

Must not have

Known history of human immunodeficiency virus (HIV), active Hepatitis B or Hepatitis C

Active autoimmune disease requiring systemic treatment in past 2 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up upon completion of 12 month follow-up period for the final participant enrolled to the study.

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether immunotherapy is effective in treating cancer in patients also receiving treatment with steroids.

Who is the study for?

This trial is for adults with brain tumors who need steroids to reduce swelling and have started steroid therapy. They must be eligible for standard immunotherapy, have measurable brain disease, stable thyroid issues on hormones if present, and use birth control if applicable. Excluded are those with HIV, hepatitis B/C, recent autoimmune treatments or severe drug allergies.

What is being tested?

The study tests whether immunotherapy can still work effectively in patients who also require steroids due to brain metastases from cancers like melanoma or lung cancer. It compares the effects of different steroids alongside standard immune checkpoint inhibitors.

What are the potential side effects?

Potential side effects may include typical reactions to immunotherapies such as fatigue, skin reactions, inflammation of organs (like lungs or intestines), hormonal imbalances and possible worsening of underlying autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

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

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I am able to get out of my bed or chair and move around.

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I have been diagnosed with melanoma, lung, kidney, or genitourinary cancer.

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My cancer has spread outside of my brain.

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I am eligible for standard immune therapy.

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I am 18 years old or older.

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I have a brain tumor that can be measured.

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My blood, kidney, liver, and clotting tests are within normal ranges.

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I am on corticosteroids for brain metastases.

Exclusion Criteria

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

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I have a history of HIV, Hepatitis B, or Hepatitis C.

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I have been treated for an autoimmune disease in the last 2 years.

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I am taking medication that suppresses my immune system, but it's not a steroid.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ upon completion of 12 month follow-up period for the final participant enrolled to the study.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~upon completion of 12 month follow-up period for the final participant enrolled to the study.

This trial's timeline: 3 weeks for screening, Varies for treatment, and upon completion of 12 month follow-up period for the final participant enrolled to the study. for reporting.