Vorinostat + Chemotherapy for Cancer

(NYMC195 Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Jeremy Rosenblum, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: New York Medical College

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests a new mix of four medicines to treat tumors that are hard to treat with usual methods. The goal is to find the safest dose and see if this combination can effectively fight these tough tumors.

Research Team

Jeremy Rosenblum, MD

Principal Investigator

New York Medical College

Eligibility Criteria

This trial is for young patients (1 to 30 years old) with relapsed or refractory solid tumors or CNS malignancies. They must have adequate organ function, not received certain treatments recently, and cannot be pregnant or breastfeeding. Those with uncontrolled infections, allergies to protocol drugs, or recent use of specific inhibitors are excluded.

Inclusion Criteria

You have enough infection-fighting white blood cells in your body.

It's been over 14 days since my last radiation therapy, or longer for specific types.

Your hemoglobin level is 8 gm/dL or higher.

Exclusion Criteria

I am not allergic to vincristine, irinotecan, temozolomide, or vorinostat.

My child has neurofibromatosis Type 1 and is being treated for a low grade brain tumor.

I haven't taken valproic acid or similar drugs in the last 2 weeks.

Treatment Details

Interventions

• Vorinostat (Histone Deacetylase Inhibitor)

Trial Overview The study tests the highest safe dose of vorinostat combined with vincristine, irinotecan, and temozolomide in children and young adults. It aims to determine side effects, impact on tumor cell molecules, and overall treatment effectiveness against stubborn tumors.

Participant Groups

Group I: Vorinostat Experimental Treatment 1 Intervention

The first cycle of chemotherapy will not include the experimental agent vorinostat. This first cycle will be used to determine whether the patient can tolerate the chemotherapeutic backbone without developing a DLT. Cycle 1 * Vincristine: 1.5 mg/m2/day (maximum dose 2 mg) IV Days 1 and 8 over 1-15 minutes. * Temozolomide: 125 mg/m2/day PO Days 1-5. * Irinotecan: 50 mg/m2/day IV Days 1-5 over 60 minutes. * Cefixime: 8 mg/kg/day (maximum dose 400 mg) PO. Begin 2 days prior to irinotecan therapy and continue through Day 8. Cycles 2-12 * Vincristine: 1.5 mg/m2/day (maximum dose 2 mg) IV Days 1 and 8 over 1-15 minutes. * Temozolomide: 125 mg/m2/day PO Days 1-5. * Irinotecan: 50 mg/m2/day IV Days 1-5 over 60 minutes. * Cefixime: 8 mg/kg/day (maximum dose 400 mg) PO. Begin 2 days prior to irinotecan therapy and continue through Day 8. * Vorinostat: Dose per escalation schema daily Days 1-5. * Vorinostat will not be administered during Cycle 1.

Who Is Running the Clinical Trial?

New York Medical College

Lead Sponsor

Trials

73

Recruited

8,700+

Edward C. Halperin

New York Medical College

Chancellor and Chief Executive Officer since 2012

B.S. in Economics, Summa Cum Laude, The Wharton School, University of Pennsylvania; M.A., Liberal Studies, Duke University; M.D., Cum Laude, Yale University

Machelle Allen

New York Medical College

Chief Medical Officer since 2017

MD from New York Medical College