Is NCT06487481 recruiting in Bethesda, MD?

Yes, NCT06487481 is currently recruiting participants at its Bethesda, MD location. This adrenocortical carcinoma (acc) clinical trial is actively enrolling qualified participants.

How do I join the adrenocortical carcinoma (acc) 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.

Adrenocortical Carcinoma (ACC) Clinical Trial in Bethesda, MD

About This Adrenocortical Carcinoma (ACC) Study in Bethesda

Background: Adrenocortical carcinoma (ACC) is a rare cancer of the adrenal glands. ACC often returns after tumors are removed with surgery. Less than 35% of people with ACC survive 5 years after diagnosis. Objective: To test a new type of external beam RT before surgery in people with ACC. Eligibility: People aged 18 years and older with ACC that came back after treatment but may be safely removed with surgery. Design: Participants will be screened. They will have a physical exam with blood and urine tests. They will have tests of their heart function. They will have imaging scans. A small sample of tumor tissue may be collected if one is not available. They will undergo laparoscopy: Small incisions will be made in the abdomen so that a thin tube with a light and camera can be inserted to view the organs. RT comes from a machine that aims radiation at tumors. Participants will receive preoperative RT in daily fractions over approximately 2-3 weeks, followed by a planned surgical resection about 4 weeks after the completion of RT. Visits will last 30 to 60 minutes. Participants will undergo surgery to remove their tumors about 4 weeks after they finish RT. They will stay in the hospital 1 to 3 weeks after surgery. Participants will have follow-up visits for 10 years after surgery.

Sponsor: National Cancer Institute (NCI)

Who Can Participate

Inclusion Criteria

Age \>= 18 years

Pathological confirmation of ACC by the Laboratory of Pathology, NCI. Note: Confirmation may be done from archival sample; fresh tissue is not required unless otherwise acquired for clinical purposes.

Measurable disease by RECISTv1.1. criteria at enrollment

Evidence of recurrent ACC amenable to surgical resection that can be performed at NIH Clinical Center (CC)

Must be suitable for external beam radiotherapy AND surgery in the opinion of the treating investigator (e.g., based on clinical history and imaging)

Participants with metastatic ACC outside the area(s) to be exposed to investigational treatments (e.g., liver parenchyma, lung\[s\], or bone\[s\]) must have disease that is amendable for a complete resection and/or catheter-based and/or radiation-based ablation.

Mitotane therapy- Participants may be receiving mitotane currently, have received it in the past, or never have received mitotane. However, participants will be evaluated in separate cohorts based on mitotane use and, as enrollment is sequential, not all participants may be eligible for the study at all times. Note: Participants with a history of mitotane use may continue on study at the discretion of the treating investigator. Participants will not initiate mitotane on study.

Participants must agree to undergo tumor biopsy of easily accessible tumor sites prior to study treatment.

Performance Status (ECOG) 0-2

Adequate organ function, including:

Hemoglobin \>= 9.0 gm/dL

ANC \>= 1,500/mm\^3

Platelets \>= 75,000/mm\^3

AST and ALT \<= 3 x Upper Limit Normal (ULN)

Bilirubin \<= 2 x ULN

Creatinine within normal institutional limits or creatinine clearance \>60 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal calculated using eGFR.

Individuals of childbearing potential must agree to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) prior to RT and continue until at least 4 months following cytoreduction surgery.

Nursing (including breastfeeding) participants must agree to discontinue nursing prior to RT and continue until at least 4 months following cytoreductive surgery.

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

Participants must agree to co-enroll in tissue collection protocol 09C0242 "Prospective comprehensive molecular analysis of endocrine neoplasms."

Exclusion Criteria

Primary ACC or suspicious/indeterminate adrenal tumor without pathological confirmation

Prior abdominal radiation therapy

Participants who have received chemotherapy, immunotherapy, investigational therapy, or radiotherapy treatment within the last 4 weeks prior to starting treatment and/or have not recovered from toxicities to less than grade 2 CTCAE.

Infection requiring parenteral antibiotics

Suspected or proven ACC peritoneal metastasis

Pre-existing known or suspected radiation sensitivity syndromes

Prohibitive condition(s) to diagnostic laparoscopy

Participants who have an unacceptable risk for a major surgical procedure such as participants with high risks for major cerebro-cardiovascular (such as those who had doxorubicin exposure as based on screening echocardiogram and ECG) and pulmonary complications and those with estimated perioperative mortality greater than 15% per ACS NSQIP Surgical Risk calculator.

Participants receiving other investigational therapies

Participant pregnancy

Active systemic infections, coagulation disorders, or other major medical illnesses such as uncontrolled diabetes mellitus, uncontrolled hypertension (persistently grade 2 or worse), active severe cerebro-cardio-pulmonary diseases, and acute major organ dysfunction.

Acute intraabdominal conditions such as obstruction or peritonitis at the time of the evaluation or surgery.

Evidence at screening of or currently active CNS metastasis within 6 months of RT; participants with history of treated brain metastases with intracranial recurrence within 6 months prior to treatment. Note: Participants with any signs or symptoms suggestive of previously undiagnosed brain metastasis at screening or with a history of brain metastasis should receive imaging at screening; otherwise, imaging is not required.

HIV-positive participants with CD4 below 200 or who are not on anti-retroviral therapy

Participants who have a history of another primary malignancy from which the participant has been disease-free for \< 3 years at the time of enrollment.

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 (NCT06487481) 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.

Adrenocortical Carcinoma (ACC) Treatment Options in Bethesda, MD

If you're searching for adrenocortical carcinoma (acc) treatment options in Bethesda, MD, this clinical trial (NCT06487481) 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 adrenocortical carcinoma (acc) 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 adrenocortical carcinoma (acc) clinical trials near you to find additional studies recruiting in your area.

Adrenocortical Carcinoma (ACC) Clinical Trial in Bethesda, MD

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