CUDC-907 for Pediatric Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byDavid S Shulman, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called CUDC-907 to see if it can help children with certain cancers that haven't responded to other treatments. The drug works by blocking proteins that help cancer cells grow. The main goal is to find the safest dose for children and see if the drug has any benefits.

Research Team

David S Shulman, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for children and young adults aged 1 to 21 with relapsed or refractory solid tumors, CNS tumors, or lymphoma. They must have a performance status of at least 50%, measurable disease, normal organ function, be able to swallow medication without chewing, and not be pregnant or breastfeeding. Participants need stable neurological conditions and can't be on certain medications like corticosteroids (unless for specific diseases), NSAIDs, anticoagulants, or have uncontrolled illnesses.

Inclusion Criteria

Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy

Patients must have normal organ function as defined

Patients must be able to swallow either intact capsules or mini-tabs without chewing

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Exclusion Criteria

Patients must not be receiving non-steroidal anti-inflammatory drugs, oral anticoagulants, and therapeutic heparins

Pregnant participants will not be entered on this study

Breastfeeding mothers are not eligible

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Treatment Details

Interventions

CUDC-907 (Histone Deacetylase (HDAC) Inhibitor and PI3K Inhibitor)

Trial OverviewThe study is testing CUDC-907's effectiveness in treating pediatric patients who haven't responded well to standard treatments for various types of cancer including neuroblastoma and brain tumors. It aims to find out if this new drug can help where other treatments haven't worked.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: CUDC-907Experimental Treatment1 Intervention

* CUDC-907 orally administered * CUDC-907 once daily for 5 consecutive days per week followed by two days without dosing * Dose level assigned at registration * Pre-dose pharmacokinetic blood sample will be collected * Dose escalation will follow a standard 3+3 design