Actively Recruiting
Vorinostat in Combination With Chemotherapy in Relapsed/Refractory Solid Tumors and CNS Malignancies
Led by New York Medical College · Updated on 2026-04-15
30
Participants Needed
1
Research Sites
563 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Investigators are testing new experimental drug combinations such as the combination of vorinostat, vincristine, irinotecan, and temozolomide in the hopes of finding a drug that may be effective against tumors that have come back or that have not responded to standard therapy. The goals of this study are: * To find the highest safe dose of vorinostat that can be given together with vincristine, irinotecan, and temozolomide without causing severe side effects; * To learn what kind of side effects this four drug combination can cause; * To learn about the effects of vorinostat and the combination of vorinostat, vincristine, irinotecan, and temozolomide on specific molecules in tumor cells; * To determine whether the combination of vorinosat, vincristine, irinotecan, and temozolomide is a beneficial treatment.
CONDITIONS
Official Title
Vorinostat in Combination With Chemotherapy in Relapsed/Refractory Solid Tumors and CNS Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 1 and 30 years at the start of treatment
- Confirmed diagnosis of a relapsed or refractory solid tumor or CNS malignancy
- Karnofsky performance score of at least 50 for patients over 16 years old
- Lansky performance score of at least 50 for children under 16 years old
- Prior treatment with vincristine, irinotecan, or temozolomide allowed, but not the combination of irinotecan and temozolomide
- No myelosuppressive therapy within 3 weeks or nitrosourea chemotherapy within 6 weeks before starting the study
- No growth factor support with G-CSF within 3 days or peg-filgrastim within 7 days before starting
- At least 21 days or 5 half-lives since last biologic antineoplastic therapy
- At least 14 days since last local radiation therapy; at least 6 months since total body irradiation, craniospinal radiation, or >50% pelvic radiation; at least 6 weeks since substantial bone marrow radiation
- No active graft versus host disease or immunosuppressive therapy after stem cell transplant; at least 3 months since neutrophil engraftment
- Adequate bone marrow function: ANC ≥ 1000 cells/mcL, platelet count ≥ 100,000/mcL with no transfusion in prior 7 days, hemoglobin ≥ 8 gm/dL
- Patients with bone marrow disease may enroll if ANC ≥ 750 cells/mcL but will not be evaluable for blood toxicity
- Adequate liver function: total bilirubin ≤ 1.5 times upper limit of normal, ALT ≤ 5 times upper limit, serum albumin ≥ 2 gm/dL
- Adequate kidney function: creatinine clearance or glomerular filtration rate >70 ml/min/1.73 m2 or age- and gender-appropriate serum creatinine levels
- Written informed consent from patients or their guardians
You will not qualify if you...
- Pregnant or breastfeeding women
- Patients with CNS tumors not on a stable or decreasing corticosteroid dose for 7 days before starting therapy
- Receiving any other antineoplastic therapy
- Allergy or intolerance to vincristine, irinotecan, temozolomide, vorinostat, or cephalosporins
- Uncontrolled infection or positive blood culture within 48 hours before enrollment
- Diagnosed or treated for Clostridium difficile infection
- Use of valproic acid or other histone deacetylase inhibitors within 2 weeks before enrolling
- Children with neurofibromatosis Type 1 if treated for low grade glioma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
New York Medical College
Valhalla, New York, United States, 10595
Actively Recruiting
Research Team
H
Harshini Mahanti, BS
CONTACT
L
Lauren Harrison, MSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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