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Vorinostat with Chemotherapy for Relapsed/Refractory Solid Tumors and CNS Malignancies

This study is testing a new combination of four drugs: vorinostat, vincristine, irinotecan, and temozolomide. It's for children and young adults (ages 1 to 30) with solid tumors or brain/spinal cord cancers that have come back or haven't responded to standard treatments. The main goal is to find the highest safe dose of vorinostat that can be given with the other three chemotherapy drugs. Researchers also want to understand the side effects and how this drug combination affects cancer cells. This study aims to find a dose that can be tolerated over one year. The study plans to enroll 30 participants, but its current status is unclear.

Study design
This is a Phase I study, meaning it's focused on finding the safest dose of vorinostat when combined with other chemotherapy drugs. It plans to enroll 30 participants.
What's involved
You would first receive chemotherapy to see if you can tolerate it. Then, if tolerated, vorinostat would be added in subsequent cycles (2-12) with possible adjustments.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is to determine a maximally tolerated dose of vorinostat, measured at 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04308330

Vorinostat in Combination With Chemotherapy in Relapsed/Refractory Solid Tumors and CNS Malignancies

Recruiting
PHASE1Ages 1–30InterventionalTreatment
New York Medical College
~30 participants
Updated 2026-04-15 on ClinicalTrials.gov
What's tested:Vorinostat

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine a maximally tolerated (or optimal) dose of vorinostat
Measured over 1 year

Conditions

Ewing Sarcoma
Rhabdomyosarcoma
Wilms Tumor
Neuroblastoma
Hepatoblastoma
Germ Cell Tumor

Explore related trials

CNS MalignancyEwing SarcomaGerm Cell TumorHepatoblastomaNeuroblastomaRhabdomyosarcomaWilms Tumor

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Jeremy Rosenblum, MD · PRINCIPAL_INVESTIGATOR · New York Medical College

Who to contact

Harshini Mahanti, BS
[email protected]
914-594-2143
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age: Patients must be less than or equal to 1 year and less than or equal to 30 years of age at initiation of protocol therapy.
Diagnosis: Patients must have a confirmed histologic diagnosis of a relapsed or refractory solid tumor or CNS malignancy.
Performance status: Patients over 16 years of age must have a Karnofsky score greater than or equal to 50. Children under 16 years of age must have a Lansky score greater than or equal to 50.
Prior therapy: Patients may have received prior therapy with vincristine, irinotecan, or temozolomide. They may not however have received therapy that included a treatment cassette of irinotecan and temozolomide in combination.
Prior myelosuppressive therapy: Patients must have not received myelosuppressive therapy in 3 weeks or nitrosourea chemotherapy within 6 weeks of initiation of protocol therapy.
Hematologic growth factor support: Patients may not have received G-CSF within the previous 3 days or peg-filgrastim within the past 7 days.
Biologic anti-neoplastic therapy: At least 21 days or 5 half-lives (whichever is of longer duration) must have elapsed since the last administration of biologic antineoplastic therapy.
Radiation therapy: ≥ 14 days since the last dose of local XRT; ≥ 6 months must have elapsed if prior TBI, craniospinal XRT or ≥ 50% radiation of pelvis; ≥ 6 wks must have elapsed if other substantial BM radiation.
Autologous or allogeneic stem cell transplant: No active graft vs. host disease or need for immunosuppressive therapy. At least 3 months must have passed since neutrophil engraftment.
Organ function:
Peripheral absolute neutrophil count (ANC) greater than or equal to 1000 cells/mcL.
Platelet count greater than or equal to100,000/mcL and no platelet transfusion within prior 7 days.
Hemoglobin greater than or equal to 8 gm/dL
Patients with known bone marrow metastatic disease may enroll on the study if they have a peripheral ANC greater than or equal to 750 cells/mcL. They will not be evaluable for hematologic toxicity.
Total bilirubin less than or equal to 1.5x upper limit of normal (ULN) for age.
SGPT (ALT) less than or equal to 5x ULN
Serum albumin greater than or equal to 2 gm/dL
Creatinine clearance or glomerular filtration rate \>70 ml/min/1.73 m2 or a serum creatinine based on age and gender as follows:

Exclusion

Pregnancy or breast feeding: Women who are pregnant or breast feeding will not be entered on the protocol due to the risks of fetal and teratogenic adverse events with the therapeutic agents used in the protocol therapy.
Corticosteroid use: Patients with CNS tumors who have not been on a stable or decreasing dose of corticosteroids for the 7 days prior to the initiation of protocol therapy.
Antineoplastic therapy: Patients receiving any other antineoplastic therapy.
Medication allergy:
Infection: Patients who have any uncontrolled infection, positive blood culture within 48 hours prior to protocol entry, or diagnosed or receiving therapy for Clostridium difficile infection.
Patients may not have taken valproic acid or any other histone deacetylase inhibitor for at least 2 weeks prior to study enrollment.
Children with neurofibromastosis Type 1, if being used for treatment of a low grade glioma.

What this trial measures

  • To determine a maximally tolerated (or optimal) dose of vorinostat1 year

    A minimum of 3 evaluable patients will be entered at each dose level. If no significant dose limiting toxicity is discovered, a maximum of 3 dose levels will be evaluated. The minimum patient enrollment will be 3 patients. Many of the patients enrolled on this trial are expected to be heavily pretreated. All patients will be given a VIT only "window" to evaluate adequate bone marrow reserve to tolerate protocol therapy. We expect that at most 20% of patients will not be able to tolerate VIT or VIT with dose reduced temozolomide. A maximum of 24 patients enrolled on study is anticipated. Once the MTD has been defined, up to 6 additional patients may be enrolled to acquire additional safety data regarding this combination of agents.