Study on Belinostat Dosing Based on Genetic Variants for Treating High-Grade Neuroendocrine Carcinomas
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT06406465
This clinical trial is exploring how different doses of the drug belinostat, based on genetic differences, can be used to treat high-grade neuroendocrine carcinomas (HGNEC). The study aims to find the best dosage for patients with specific gene variants to improve treatment outcomes.
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Program Overview
High-grade neuroendocrine carcinomas (HGNEC) are aggressive cancers that can occur in various parts of the body. This study is testing different doses of the drug belinostat, combined with etoposide and cisplatin, to see if adjusting the dose based on genetic differences can help treat HGNEC more effectively. Participants will receive these drugs through an IV in 21-day cycles, with regular clinic visits for monitoring and tests. The study will continue for up to 5 years if the treatment is beneficial.
Description
This study focuses on treating high-grade neuroendocrine carcinomas (HGNEC) with a combination of drugs: belinostat, etoposide, and cisplatin. Researchers are interested in how genetic differences affect the way belinostat works in the body. By adjusting the dose of belinostat based on specific genetic markers, the study aims to improve treatment effectiveness.
Participants will receive the drugs through an IV in cycles lasting 21 days. For the first six cycles, they will visit the clinic for four days to receive all three drugs. After six cycles, if the treatment is helping, participants may continue with belinostat alone for up to five years, with clinic visits for the first three days of each cycle.
The study includes regular tests and scans to monitor the cancer and check for any side effects. Participants will have a follow-up visit 30 days after their last dose of belinostat and will continue to have follow-up contacts every 3 to 6 months by phone or email.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of high-grade neuroendocrine carcinoma (HGNEC) that cannot be treated with standard therapies.
- Must be 18 years or older.
- Can continue certain ongoing treatments for prostate cancer or bone metastases if applicable.
- Must have measurable or evaluable disease.
- Must be in good overall health with an ECOG performance status of 0 to 2.
- Must have adequate blood cell counts and organ function as determined by specific tests.
- Can participate if hepatitis B or C is under control.
- Women of childbearing potential must use effective contraception during the study and for 14 months after the last dose. Men must use effective contraception during the study and for 11 months after.
- Must be willing to stop breastfeeding during the study and for 3 months after the last dose.
- Must be willing to follow study procedures and sign an informed consent document.
Exclusion Criteria
- Cannot have received certain treatments, like investigational drugs or chemotherapy, within 14 days before starting the study.
- Cannot have a history of severe allergic reactions to the study drugs.
- Cannot have untreated or progressing brain metastases.
- Cannot have unresolved side effects from previous treatments, except for certain conditions like hair loss.
- Cannot be taking certain medications that interact with the study drugs.
- Cannot have platinum-refractory disease or have used other similar drugs recently.
- Cannot be pregnant or have significant heart disease.
- Cannot have had more than one prior systemic therapy.
- Cannot have certain heart conditions or be taking medications that affect heart rhythm.
- Cannot have uncontrolled illnesses that would interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| National Institutes of Health Clinical Center | 20892 | Bethesda | Maryland |
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