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Beta Blocker

Propranolol + Radiation Therapy for Soft Tissue Sarcoma

Phase 1

Waitlist Available

Led By Anurag K Singh

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years old

Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2

Must not have

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Contraindication to beta-blockers e.g.; uncontrolled depression, unstable angina pectoris, uncontrolled heart failure (New York Heart Association [NYHA] grade III or IV), hypotension (systolic blood pressure < 85 or fasting plasma glucose > 160 mg/dL at screening), symptomatic peripheral arterial disease or Raynaud's syndrome, untreated pheochromocytoma, current nondihydropyridines calcium channel blocker use (such as verapamil, diltiazem) or rhythm control agents such as digoxin and amiodarone. Patients with pacemakers will be excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing the safety and effectiveness of adding propranolol to standard radiation therapy before surgery for patients with soft tissue sarcoma. Soft tissue sarcomas are rare tumors that arise from connect

Who is the study for?

This trial is for patients with soft tissue sarcoma who are preparing to undergo surgery. It's designed to test if adding a blood pressure medication, propranolol, to standard radiation therapy before surgery can be safe and improve treatment outcomes.

What is being tested?

The study is examining the safety and effects of combining propranolol with standard radiation therapy prior to surgical removal of the tumor in soft tissue sarcoma patients. The goal is to see if this combination makes tumors smaller and enhances patient response.

What are the potential side effects?

Potential side effects may include those commonly associated with radiation therapy such as skin changes, fatigue, mild swelling, and nausea. Propranolol might cause low blood pressure, slow heart rate, dizziness or other cardiovascular-related symptoms.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I can perform daily activities with minimal assistance.

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I am a candidate for radiation therapy aimed at curing my soft tissue sarcoma in a limb.

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I can swallow and keep down pills.

Exclusion Criteria

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

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I do not have conditions that prevent me from taking beta-blockers.

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I am currently pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of adverse events

Secondary study objectives

Catecholamines

Changes in immune markers

Metabolites

+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 (propranolol, RT, surgery)Experimental Treatment7 Interventions

Patients receive propranolol PO BID for 2 weeks prior to standard of care RT (weeks 1 and 2) and then during and after standard of care RT (weeks 3-7). Treatment continues in the absence of disease progression or unacceptable toxicity until the time of standard of care surgery (week 8). Additionally, patients undergo PET scan and/or CT scan during screening and may undergo blood and tissue biopsy sample collection throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Propranolol

2010

Completed Phase 4

~1290

Biopsy

2014

Completed Phase 4

~1150