Is NCT05104736 recruiting in Bethesda, MD?

Yes, NCT05104736 is currently recruiting participants at its Bethesda, MD location. This thymic epithelial tumor clinical trial is actively enrolling qualified participants.

How do I join the thymic epithelial tumor 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.

Thymic Epithelial Tumor Clinical Trial in Bethesda, MD

About This Thymic Epithelial Tumor Study in Bethesda

Background: There are no approved drugs to treat recurrent thymoma and thymic carcinoma. New therapies are needed for people with these cancers. Researchers want to see if the drug PT-112 can help. PT-112 kills cancer cells. It also helps the body s immune system fight cancer. Objective: To see if the study drug PT-112 can cause tumors to shrink. Eligibility: People ages 18 and older who have thymoma or thymic cancer and whose disease returned or progressed after treatment with at least one platinum-containing chemotherapy, or who have refused standard treatment. Design: Participants will be screened with: Review of medical history and medications Physical exam Blood and urine tests CT or MRI scans of parts of the body, including the brain Participants will get PT-112 in 28-day cycles, on days 1 and 15 of of the first cycle and on day 1 of each cycle after that. They will get the drug by infusion through a catheter. The catheter is a small plastic tube put into a vein. On days they receive the drug, participants will have physical exams and blood and urine tests. They will have an ECG to test heart function on day 1 of each cycle. Participants will have scans every 8 weeks. Participants may choose to have tumor biopsies on day 1 of cycles 1 and 3. Biopsies may be guided by an ultrasound or CT scan. Participants will continue treatment as long as they can handle the side effects and their disease does not get worse, for up to 8 years. Participants will have follow-up visits 2 weeks and 4 weeks after they stop therapy. Then the study team will check on participants every 3 months until 8 years after the participant joined the study.

Sponsor: National Cancer Institute (NCI)

Who Can Participate

Inclusion Criteria

Participants must have histologically confirmed thymoma or thymic carcinoma.

Participants should have received at least one prior line of platinum-based chemotherapy. For participants who have refused cytotoxic chemotherapy, a rationale for refusal to receive standard first-line therapy will be captured in the case report form and the medical record. Progressive disease must be documented prior to study entry and participants must have advanced, unresectable disease that is not amenable to surgical resection.

Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1.

Participants must be aged \>=18 years.

ECOG performance status \<=1.

Participants must have adequate organ and marrow function as defined below:

absolute neutrophil count \>= 1,500/mm3 OR \>= 1.5 x 10(9)/L

platelets \>=100,000/mm3 OR (Bullet) 100 x 10(9)/L

hemoglobin \>= 9g/dL (may have been transfused, at least 7 days prior)

total bilirubin \<= 1.5 x the upper limit of normal range (ULN)

AST(SGOT)/ALT(SGPT) \<= 2.5 x ULN OR \<= 5 x ULN for participants with documented metastatic disease to the liver

creatinine \<= 1.5x ULN OR:

creatinine clearance \>= 60 mL/min/1.73 m2 calculated by calculated using eGRF in the clinical lab

Negative serum or urine pregnancy test at screening for individuals of childbearing potential (IOCBP). NOTE: IOCBP is defined as any individual who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal. Absence of pregnancy must be demonstrated unless there is proven menopause (age \>= 50 years and last menarche \>= 3 years, or documented menopausal sex hormone profile, or surgical castration) at screening.

Participants must not become pregnant or start breast feeding during the study. Breastfeeding should be discontinued if the mother is treated with PT-112.

Individuals of child-bearing potential and those that can father children with a sexual partner of childbearing potential must use medically effective contraception during the study and for 6 months after the last dose of study medication.

Participants with previously treated brain or CNS metastases are eligible provided that the participant has recovered from any acute side effects of radiotherapy and does not require treatment with steroids, and any whole brain radiation therapy was completed at least 2 weeks prior to initiation of study therapy.

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

Exclusion Criteria

History of allergic reactions attributed to compounds of similar chemical or biologic composition to PT-112. Since there is no definitive list of compounds of similar chemical or biologic composition to PT-112, the principal investigator if in doubt, will report known allergies to the pharmacist to make a determination as to whether it is safe to enroll a participant.

Concurrent treatment with a non-permitted drug.

Concurrent anticancer treatment within 14 days before initiation of study therapy (includes radiotherapy; however, palliative bone-directed radiotherapy is permitted).

Major surgery within 14 days before enrollment (excluding prior diagnostic biopsy).

Concurrent systemic therapy with immunosuppressive agents within 14 days (or 5 half-lives of a drug, whichever is shorter) before initiation of study therapy.

Use of hormonal agents for anti-cancer therapy within 14 days before initiation of study therapy; or use of any investigational drug within 14 days before initiation of study therapy.

History of previous malignant disease within the last 2 years with the following exceptions: basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast, papillary or follicular thyroid carcinoma, and non-muscle invasive bladder cancer.

Active infection requiring systemic therapy or significant acute or chronic infections including, among others:

Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive).

Known history of testing positive for HIV or known acquired immunodeficiency syndrome with a detectable viral load. However, participants with HIV who have an undetectable viral load and are on stable doses of Highly Active Antiretroviral Therapy (HAART) can be screened for the study.

Persisting toxicity related to prior therapy (NCI CTCAE v. 5 Grade \> 1) with the exception of, alopecia, sensory neuropathy Grade \<= 2 and hearing loss Grade \<=2.

Known alcohol or drug abuse.

Uncontrolled intercurrent illness including, but not limited to the following:

Cardiovascular: SYMPTOMATIC congestive heart failure, unstable angina pectoris or cardiac arrhythmia, either active or within the past 6 months

Respiratory: Pneumonitis or Idiopathic pulmonary fibrosis (not radiation-associated fibrosis), either active or within the past 6 months

Gastrointestinal: Immune colitis or inflammatory bowel disease, either active or within the past 6 months

Hematological: Bleeding diathesis or major bleeding events, either active or within the past 6 months

Other: psychiatric illness/social situations that would limit compliance with study requirements, including active suicidal ideation or behavior, either active or within the past 12 months

Administration of live vaccines within 4 weeks prior to treatment. COVID-19 vaccines are permitted at screening.

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 (NCT05104736) 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.

Thymic Epithelial Tumor Treatment Options in Bethesda, MD

If you're searching for thymic epithelial tumor treatment options in Bethesda, MD, this clinical trial (NCT05104736) 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 thymic epithelial tumor 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 thymic epithelial tumor clinical trials near you to find additional studies recruiting in your area.

Thymic Epithelial Tumor Clinical Trial in Bethesda, MD

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