Is NCT04941274 recruiting in Bethesda, MD?

Yes, NCT04941274 is currently recruiting participants at its Bethesda, MD location. This kaposi sarcoma clinical trial is actively enrolling qualified participants.

How do I join the kaposi sarcoma clinical trial in Bethesda?

To join this clinical trial in Bethesda, 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 Bethesda 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 Bethesda, MD

About This Kaposi Sarcoma Study in Bethesda

Background: Kaposi Sarcoma (KS) is common in people with human immunodeficiency virus (HIV) but can also occur in people who do not have HIV. KS tumors usually involve the skin, but may also involve lymph nodes, lungs, bone, and gastrointestinal tract. Researchers want to see if a drug that is currently used to treat a type of breast cancer can help. Objective: To find a safe dose of abemaciclib to treat KS and to see if it can shrink lesions or tumors. Eligibility: People ages 18 and older with KS. Design: Participants will be screened with some or all of the following: Medical history Physical exam Blood and urine tests Chest x-ray and/or computed tomography scans Lung or gastrointestinal tract exam with an endoscope (a flexible instrument to examine the interior of the organ) Medicine review Heart function tests KS lesion assessment Skin sample from a KS lesion Treatment will be given in 28-day cycles. Participants will take the study drug tablets by mouth everyday. They will keep a medicine diary. They will get the study drug until their cancer gets worse or they have unacceptable side effects. Participants who stopped taking abemaciclib because it was no longer providing additional benefit may be able to restart abemaciclib again. Participants will have a study visit at the beginning of each cycle. At these visits, they will repeat some screening tests. They may have medical photographs taken of body surfaces. They may complete questionnaires about their quality of life. They may give skin and saliva samples. For skin samples, an area of skin will be numbed. A small circle of skin over an area affected by KS will be removed. Participants will have follow-up visits for up to 2 years after treatment ends.

Sponsor: National Cancer Institute (NCI)

Who Can Participate

Inclusion Criteria

Participants must have Kaposi sarcoma confirmed by the Laboratory of Pathology, NCI

Measurable disease as follows:

All participants in Groups 1, 2a, or 2b or 4 should have at least five measurable cutaneous KS lesions per AIDS Clinical Trials Group Oncology Committee (ACTG) criteria with no previous local radiation, surgical or intralesional cytotoxic therapy that would prevent response assessment for that lesion and/or evaluable disease per RECIST criteria.

Measurable disease by the criteria proposed by the AIDS Clinical Trials Group Oncology Committee.

Participants in Group 3 must have Stage T1 KS with at least five measurable cutaneous KS lesions per ACTG criteria and/or evaluable disease per RECIST criteria.

Participants may be HIV positive or negative.

Participants must be able to swallow oral medications

For all groups, participants must have adequate organ and marrow function as defined below:

Absolute neutrophil count \>1,000/mcL

Platelets \>75,000/mcL

Hemoglobin \>= 8gm/dL

Total bilirubin \<= 1.5 upper limit of normal unless the participant is receiving a protease inhibitor known to be associated with increased bilirubin (e.g. atazanavir), in which case total bilirubin \<= 7.5 mg/dL with direct fraction \<= 0.7

AST/ALT \<3 X institutional upper limit of normal

Creatinine within normal institutional limits OR

Creatinine clearance \>45 mL/min/1.73 m\^2 as estimated by either Cockroft-Gault or 24-hour urine collection for participants with creatinine levels above institutional normal

Cardiac ejection fraction \> 45% by echocardiogram

Prior treatment as follows:

Phase I: Participants must have received at least 1 prior line of systemic therapy for KS with either plateau in response, progressive disease, or inadequate response to treatment. Previous local therapy or radiation is not considered systemic therapy.

Group 2a: Individuals must have received at least 1 prior line of systemic therapy for KS with either plateau in response, relapsed disease, progressive disease, or inadequate response to treatment

Group 2b: Individuals have not received prior systemic therapy for KS. Previous local therapy or radiation is not considered systemic therapy.

Group 3: Evidence of Stage T1 KS with either a) edema or ulcerated KS and/or b) extensive oral KS and/or c) visceral KS involvement

Group 4: Participants that received prior treatment with abemaciclib with evidence of response (at least a partial response per ACTG criteria and/or RECIST) to abemaciclib.

Participants in Cohort 4 must:

have been previously enrolled in Cohorts 1-3

have at least prior documentation of PR in prior cohort

not have come off treatment for any \>Grade 3 abemaciclib-related AE.

Age \>18 years

Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<= 2 (Karnofsky \>= 60%.

Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy are eligible for this trial.

Willingness to adhere to antiretroviral therapy (ART)

All participants must have received ART for 8 weeks prior to enrollment, with no evidence of KS improvement over the most recent 4 weeks

For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV VL must be undetectable on suppressive therapy, if indicated.

Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection who are currently on treatment are eligible if they have an undetectable HCV VL.

No uncontrolled severe concurrent bacterial, viral, or fungal infections.

Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.

Contraception requirements as follows:

Participants of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception (e.g., intrauterine device \[IUD\], hormonal, surgical sterilization, abstinence) prior to study entry, for the duration of study participation, and for up to 4 months after completion of abemaciclib administration

Participants able to father a child must with partners of childbearing potential agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment for up to 4 months after completion of abemaciclib administration. Individuals with partners of childbearing potential should ask their partners to be on an effective birth control (hormonal, IUD, surgical sterilization).

Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the nursing person with abemaciclib, nursing should be discontinued if the nursing person is treated with abemaciclib.

Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

Participants who have had chemotherapy or immunotherapy within 3 weeks prior to entering the study.

Participants who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and enrollment.

Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia or neuropathy.

Participants who are receiving any other investigational agents.

History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to CDK inhibitor.

Participants receiving any ART or other medications that are strong/moderate inhibitors of CYP3A4 must have dose reductions per Strong/Moderate CYP3A4 inhibitors.

Serious and/or uncontrolled severe intercurrent illness that in the judgement of the investigator would preclude participation in the study.

No active KSHV-associated multicentric Castleman disease, KSHV-associated inflammatory cytokine syndrome or primary effusion lymphoma.

Psychiatric illness/social situations that would limit adherence with study requirements.

Prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the regimen are eligible for this trial

Participants with interstitial lung disease

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 Bethesda?

Yes, this clinical trial (NCT04941274) has an active research site in Bethesda, MD 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 Bethesda, MD

If you're searching for kaposi sarcoma treatment options in Bethesda, MD, this clinical trial (NCT04941274) 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 Bethesda research site is actively enrolling participants for this phase 1/2 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 Bethesda, MD

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