Is NCT06052618 recruiting in Bethesda, MD?

Yes, NCT06052618 is currently recruiting participants at its Bethesda, MD location. This kshv inflammatory cytokine syndrome (kics) clinical trial is actively enrolling qualified participants.

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.

KSHV Inflammatory Cytokine Syndrome (KICS) Clinical Trial in Bethesda, MD

Q: How do I join the kshv inflammatory cytokine syndrome (kics) 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.

About This KSHV Inflammatory Cytokine Syndrome (KICS) Study in Bethesda

Background: Kaposi sarcoma herpesvirus (KSHV)-associated inflammatory cytokine syndrome (KICS) and KSHV-multicentric Castleman disease (MCD) occur in people living with HIV. These diseases cause severe inflammation that can be fatal if not treated. Objective: To test a drug (pacritinib) in people with KSHV-associated KICS or MCD. Eligibility: People aged 18 years and older with KSHV-associated KICS or MCD. They must have at least one symptom. Design: Participants will be screened. They will have a physical exam with blood tests and tests of their heart function. They will have imaging scans. Their ability to perform everyday tasks will be reviewed. In some participants who have Kaposi sarcoma (KS) with KICS or MCD, these individuals may need a bronchoscopy and/or endoscopy of the upper or lower intestine: A flexible tube with a camera and a light source will be inserted through the mouth or anus to see these structures and assess any KS. Pacritinib is a capsule taken by mouth. Participants will take the drug twice a day, every day, for up to 24 weeks. They will write down each dose in a diary. Participants will visit the clinic 3 times in the first 4 weeks. Their visits will taper to once every 4 weeks. Imaging scans, blood tests, and other tests will be repeated during these visits. Participants will give samples of saliva. They may opt to allow tissues samples to be taken from their skin and lymph nodes. Participants will have follow-up visits 7 days and 30 days after their last dose of pacritinib. After that, they will visit the clinic every 3 months for up to 1 year. The physical exam and blood, heart, and imaging tests will be repeated at these visits.

Sponsor: National Cancer Institute (NCI)

Who Can Participate

Inclusion Criteria

Participants must meet KSHV-associated Inflammatory Cytokine Syndrome (KICS) criteria or have histologically or cytologically confirmed Kaposi sarcoma herpesvirus -multicentric Castleman disease (KSHV-MCD) confirmed by the CCR, Laboratory of Pathology (LP), NCI

Age \>= 18 years

At least one clinical symptom attributed to KSHV-MCD or KICS, as follows:

Intermittent or persistent fever for at least 1 week (\>38 degrees C)

Fatigue (CTCAE - Grade \>=2)

Gastrointestinal symptoms (e.g., nausea and anorexia - CTCAE Grade \>=1)

Respiratory symptoms (e.g., cough and airway hyperreactivity - CTCAE Grade \>=1)

At least one laboratory abnormality attributed to KSHV-MCD or KICS, as follows:

Anemia (hemoglobin \[Hgb\] 7.0 - 12.5gm/dL)

Thrombocytopenia (50,000 - 150,000/mm3)

Hypoalbuminemia (\<3.4 g/dL)

Elevated C-reactive protein \[CRP\] (\>3mg/L)

No life or organ-threatening manifestations of KSHV-MCD, KICS or Kaposi Sarcoma (KS)

Eastern Cooperative Oncology Group \[ECOG\] performance status \<= 3 (Karnofsky \>=60%)

Participants must have laboratory parameters as defined below:

Total bilirubin \<=3 X upper limit of normal (ULN) or \<6X ULN for diagnosis of Gilbert's

AST(SGOT)/ALT(SGPT) \<=2.5 X ULN

PT/PTT/INR \<=1.5 X ULN

Creatinine within normal institutional limits OR Creatinine clearance \>=30mL/min/1.73 m\^2 as estimated by either Cockcroft-Gault or 24-hour urine collection for participants with creatinine levels above ULN

Participants with HIV should be receiving and willing to continue or willing to initiate an effective antiretroviral therapy (ART) regimen that excludes strong/ moderate CYP3A4 inducer or inhibitors.

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

Participants with a history hepatitis C virus (HCV) infection must have completed treatment with evidence of sustained virologic response for a period of at least 3 months.

Participants with KSHV-MCD (Cohort 2) or KICS (Cohort 3) who have received prior therapy, such as rituximab or other monoclonal antibodies, must have a wash out period of at least 3 weeks.

Participants receiving medications or substances that are substitutes of strong CYP3A4 inhibitors must have a washout period of at least 5 half-lives of the drug prior to enrollment on study.

Individuals of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception (e.g., intrauterine device \[IUD\], hormonal \[excluding hormonal contraceptives sensitive to CYP3A4 metabolism (i.e. progestin)\], surgical sterilization, abstinence) prior to study entry, for the duration of study participation, and for up to 30 days after discontinuation of the study drug.

Individuals of child-bearing potential (IOCBP) and individuals able to father a child with a partner able to become pregnant must agree to use a highly effective method of contraception (e.g., intrauterine device \[IUD\], hormonal \[excluding hormonal contraceptives sensitive to CYP3A4 metabolism (i.e. progestin, ethinylestradiol)\], surgical sterilization, abstinence) prior to study entry, for the duration of study participation, and for up to 30 days after discontinuation of the study drug. A participant may request that partner uses the highly effective form of contraception to fulfill this requirement. -Ability of participant to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

Grade \>2 symptomatic visceral KS (except for edema or non-ulcerating disease restricted to the oral cavity).

History of allergic reactions attributed to compounds of similar chemical or biologic composition to pacritinib.

Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4. Lists including medications and substances known or with the potential to interact with the specified CYP3A4 isoenzymes.

Participants with evidence of ongoing hemorrhage, active signs/symptoms of bleeding, or history of severe bleeding complications in the one year prior to enrollment.

Any history of CTCAE Grade \>= 3 cardiac events within the last 3 months.

QTc(Fredericia) prolongation \>480 ms or other factors that increase the risk for QTc prolongation (i.e., heart failure, or a history of long QT interval syndrome).

Use of concomitant medications with significant potential for QTc prolongation

History of thrombosis, troponin-positive (Tpos) or myocardial infarction within the last 6 months

Participants with moderate (Child-Pugh Score B) or severe hepatic impairment (Child-Pugh Score C)

Diagnosis of primary effusion lymphoma \[PEL\] or another lymphoma.

Participants with a prior or concurrent malignancy whose natural history or treatment that has potential to interfere with the safety or efficacy assessment of the regimen.

Pregnant individuals as evaluated by a positive serum or urine beta-hCG at screening.

There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the nursing person with pacritinib. Breastfeeding should be discontinued if the nursing person is treated with pacritinib.

Uncontrolled bacterial, mycobacterial, or fungal infection at screening.

Uncontrolled intercurrent illness that would limit compliance with study requirements, including results of hematology and chemistry testing, infection disease (etc.)

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 (NCT06052618) 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.

KSHV Inflammatory Cytokine Syndrome (KICS) Treatment Options in Bethesda, MD

If you're searching for kshv inflammatory cytokine syndrome (kics) treatment options in Bethesda, MD, this clinical trial (NCT06052618) 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 clinical trial. You'll receive care from experienced kshv inflammatory cytokine syndrome (kics) 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 kshv inflammatory cytokine syndrome (kics) clinical trials near you to find additional studies recruiting in your area.

KSHV Inflammatory Cytokine Syndrome (KICS) Clinical Trial in Bethesda, MD

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