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Histone Deacetylase Inhibitor

Belinostat for Neuroendocrine Carcinoma

Phase 2

Waitlist Available

Led By Jaydira Del Rivero, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age must be greater than or equal to 18 years

Participants must have histologically confirmed diagnosis of Extrapulmonary High-Grade Neuroendocrine Carcinomas (HGNECs) for which there is no known standard therapy capable of extending life expectancy

Must not have

Significant cardiovascular disease

Participants taking specific inhibitors must discontinue their use prior to starting treatment on this trial

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 9 weeks while on monotherapy. total study therapy will not exceed 5 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test different doses of the drug belinostat based on gene variants in people with high-grade neuroendocrine carcinomas (HGNEC). Participants will undergo screening, genetic testing

Who is the study for?

Adults with high-grade neuroendocrine carcinomas (HGNEC) are eligible for this trial. Participants must be over 18 and have a specific gene variant that affects drug metabolism, which will be determined through genetic testing. They should also have adequate organ function and not be receiving other cancer treatments.

What is being tested?

The study is examining the effects of varying doses of belinostat based on participants' gene variants, alongside standard chemotherapy drugs etoposide and cisplatin. The treatment involves multiple cycles, with potential continuation up to five years if beneficial.

What are the potential side effects?

Belinostat may cause nausea, vomiting, fatigue, low blood counts leading to increased infection risk or bleeding problems. Cisplatin can lead to kidney damage, hearing loss, and nerve issues. Etoposide might result in hair loss and mouth sores.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer is a rare type outside the lungs with no standard life-extending treatment.

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I can take care of myself but might not be able to do heavy physical work.

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I am breastfeeding but willing to stop for the trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious heart condition.

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I am not currently taking any specific inhibitors or will stop them before the trial starts.

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My cancer did not respond to platinum-based chemotherapy.

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I have had one or no systemic therapies before.

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I haven't had any cancer treatment or investigational drugs in the last 14 days.

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I have HIV with a CD4 count below 200 cells/mm3.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 9 weeks while on monotherapy. total study therapy will not exceed 5 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 9 weeks while on monotherapy. total study therapy will not exceed 5 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 9 weeks while on monotherapy. total study therapy will not exceed 5 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine if pharmacogenomic intervention can normalize the area under the curve (AUC) at cycle 6 between UGT1A1*28 and UGT1A1*60 genotypes) of belinostat administered as a continuous 48 h infusion in combination with cisplatin and etoposide ...

Secondary study objectives

To assess duration of response of belinostat administered as a continuous 48 h infusion in combination with cisplatin and etoposide in platinum sensitive

To assess duration of response of belinostat maintenance

To determine efficacy with respect to objective response rate of belinostat administered as a continuous 48 h infusion in combination with cisplatin and etoposide

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