Is NCT06445166 recruiting in St Louis, MO?

Yes, NCT06445166 is currently recruiting participants at its St Louis, MO location. This kaposi sarcoma clinical trial is actively enrolling qualified participants.

How do I join the kaposi sarcoma clinical trial in St Louis?

To join this clinical trial in St Louis, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this St Louis clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Kaposi Sarcoma Clinical Trial in St Louis, MO

About This Kaposi Sarcoma Study in St Louis

Kaposi sarcoma (KS) lesions are initiated by endothelial cells infected with KS herpesvirus (KSHV), also known as human herpesvirus 8 (HHV-8). Lesion progression is driven by abnormal angiogenesis, chronic inflammation, and uncontrolled cell proliferation. KS remains one of the most commonly diagnosed cancers in many African countries where economic constraints prevent successful treatment in most patients. Treatment outcomes in developed countries are also often unsatisfactory in HIV positive patients despite good virological and immunological responses to antiretroviral therapy. Therefore, identification of new oral, safe treatment options for treatment of KS remains a research priority. Given the known anti-angiogenic properties and based on the treatment response with other benign vascular lesions such as infantile hemangioma, propranolol is a good candidate for the treatment of KS. The hypothesis of this study is that treating patients with Kaposi sarcoma with propranolol will result in an overall response rate (complete response rate plus partial response rate) of at least 45%, and that propranolol will be safe and well tolerated in this patient population.

Sponsor: Washington University School of Medicine

Who Can Participate

Inclusion Criteria

Biopsy proven Kaposi Sarcoma that is measurable with a millimeter ruler. Patients presenting for both front-line therapy and subsequent-line therapy will be considered.

Must have two lesions greater than or equal to 4 mm x 4 mm, or one lesion greater than or equal to 8 mm x 8 mm, that are accessible for 4-mm punch biopsy. The patient must have at least 5 more lesions in addition to the lesion(s) being biopsied.

At least 18 years of age.

Weight ≥40 kg

ECOG performance status ≤ 2

Meets the appropriate HIV-related criteria:

If HIV positive, patient must be on antiretroviral therapy (ART) that conforms to local standards of care for at least 12 weeks. HIV positive patients will not be excluded based on CD4 count or HIV viral load.

If on ART 12 to 24 weeks, must show evidence of KS progression requiring further systemic treatment.

If on ART for \> 24 weeks, must show no evidence of regression in the last 8 weeks.

If HIV negative, must not show evidence of improvement in the 12 weeks prior to enrollment.

Propranolol is US FDA pregnancy category C. For this reason, women of childbearing potential must agree to use adequate contraception prior to study entry, for the duration of study participation, and for one month after completion of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, s/e must inform her treating physician immediately.

Able to take an oral pill.

Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion Criteria

Visceral disease causing functional impairment. Unless it is a minor, self-limiting (not affecting normal activities) condition.

Urgently clinically indicated for immediate cytotoxic chemotherapy. Patients who have received cytotoxic chemotherapy \> 4 weeks prior to screening are eligible.

Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial

Currently taking beta-andrenergic antagonist(s) for other indications. Prior use is allowed if the last dose of the beta-andrenergic antagonist is ≥ 5 half-lives of the agent prior to Day -7.

Currently receiving concurrent treatment with an anticancer therapy. Patients must not have received any anticancer therapies within 4 weeks prior to receiving the first dose of propranolol.

Currently receiving any other investigational agents.

A history of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to propranolol.

History of asthma or current diagnosis of obstructive airway disease such as asthma, COPD, or bronchiolitis. Patients with mild or well-controlled obstructive airway disease may be included as long as they have not had an acute episode in the last 3 mos requiring more than 4 days/mo of treatment, change of chronic treatment, or visit to medical personnel for treatment of asthma, COPD, or bronchiolitis.

History of diabetes mellitus, as defined by any of the following: A random blood glucose value of at least 200 mg/dL in the presence of hyperglycemia symptoms (weight loss, blurry vision, thirst, polyuria), fasting plasma glucose value of at least 126 mg/dL, A1c value of at least 7.0%, or two hour plasma glucose value of at least 200 mg/dL during a 75 g oral glucose tolerance test.

History of uncompensated heart failure, severe sinus bradycardia (heart rate persistently \<50 beats per minute), sick sinus syndrome, or heart block greater than first degree. Patients with isolated bradycardia may be included as long as the heart rate is at least 51 beats per minute and is asymptomatic.

History of hypotension (systolic blood pressure \<90 mmHg or mean arterial pressure \<65 mmHg) or orthostasis (\>20 mmHg fall in systolic pressure or \>10 mmHg fall in diastolic pressure with standing). (Isolated instances of hypotension may not be exclusionary after discussion with PI.)

Shortness of breath, hemoptysis, or moderate/severe cough not attributable to causes other than KS. Patients may be included if they have a minor, self-limiting condition and their O2 sat is persistently greater than 90% and there is no hemoptysis or cough severe enough to limit normal activities.

Bleeding from the mouth or rectum not attributable to causes other than KS. Unless it is a minor, self-limiting condition, such as blood tinged toilet paper.

Uncontrolled intercurrent illness including, but not limited to: ongoing clinically significant active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.

Concern for KSHV inflammatory cytokine syndrome. Patients with history of prior KSHV inflammatory cytokine syndrome may be included.

Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 21 days of study entry.

Evidence of untreated chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with active HBV infection can be enrolled as long as they are receiving HBV treatment. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.

History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in St Louis?

Yes, this clinical trial (NCT06445166) has an active research site in St Louis, MO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Kaposi Sarcoma Treatment Options in St Louis, MO

If you're searching for kaposi sarcoma treatment options in St Louis, MO, this clinical trial (NCT06445166) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our St Louis research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced kaposi sarcoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all kaposi sarcoma clinical trials near you to find additional studies recruiting in your area.

Kaposi Sarcoma Clinical Trial in St Louis, MO

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