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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

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

ACT-FAST Trial 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.Check my eligibility

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.See study design

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.

ACT-FAST Trial 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.

Select...

I am on corticosteroids for brain metastases.

ACT-FAST Trial 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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Intracranial and extracranial objective response rate

Time to initiation of therapy

Secondary outcome measures

Assessment of treatment safety

Mortality analyses

Patient-reported quality of life analysis

ACT-FAST Trial Design

2Treatment groups

Active Control

Group I: DexamethasoneActive Control1 Intervention

Dose starting at 4 mg daily (for patients randomized to the Dexamethasone arm).

Group II: PrednisoneActive Control1 Intervention

Dose starting at 25 mg/day (a calculation of equipotent steroid equivalencies will be used).

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

AHS Cancer Control AlbertaLead Sponsor

182 Previous Clinical Trials

36,192 Total Patients Enrolled

Media Library

Brain Metastases Research Study Groups: Dexamethasone, Prednisone

Brain Metastases Clinical Trial 2023: Accelerated Checkpoint Therapy Highlights & Side Effects. Trial Name: NCT04461418 — Phase 2

Accelerated Checkpoint Therapy (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04461418 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Dexamethasone been cleared by the FDA?

"Dexamethasone received a score of 2 because, while there is supporting data for its safety, there is no evidence that it is an effective medication."

Answered by AI

How many people are the researchers working with in this experiment?

"That is correct. The clinical trial in question, which can be found on clinicaltrials.gov, appears to be looking for 20 participants at present. This particular trial was posted on 3/30/2021 and has not been updated since then."

Answered by AI

Are patient volunteers still being accepted for this research project?

"Yes, as of today this trial is looking for participants. The listing was originally created on March 30th, 2021 and has not been updated since then."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Accelerated Checkpoint Therapy for Any Steroid Dependent Patient With Brain Metastases

2021. "Accelerated Checkpoint Therapy for Any Steroid Dependent Patient With Brain Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04461418.

All > Brain Metastases