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

  • End date
    Dec 17, 2022
  • participants needed
  • sponsor
    New York Medical College
Updated on 24 January 2021
platelet count
renal function
stem cell transplantation
metastatic disease
granulocyte colony stimulating factor
biologic agent
growth factor
bone marrow procedure
glomerular filtration rate
biological factors
drug combinations
colony stimulating factor
experimental drug
neutrophil count
tumor cells
blood transfusion
chemotherapy drugs
chemotherapeutic agents
cancer chemotherapy
solid tumour
solid tumor
platelet transfusion


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.


This first cycle will be used to determine whether the patient can tolerate the chemotherapeutic backbone without developing a DLT. The baseline disease evaluation will be obtained following hematologic recovery from the first cycle of chemotherapy, after which combination therapy with vorinostat will be given in subsequent cycles (2-12) w/ modifications if needed. Vorinostat dose escalation in subsequent patient cohorts will occur based on DLT to determine a MTD.

Condition Malignant neoplasm of kidney, Hepatoblastoma, Ewing's sarcoma, Hereditary Neoplastic Syndrome, Nephroblastoma, Rhabdomyosarcoma, Neuroblastoma, Germ cell tumor, Kidney Cancer, Wilms' Tumor, Germ Cell Tumors, Hereditary Cancer Syndromes, Renal Cancer, neuroblastomas
Treatment Vorinostat
Clinical Study IdentifierNCT04308330
SponsorNew York Medical College
Last Modified on24 January 2021


Yes No Not Sure

Inclusion Criteria

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
Bone marrow 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
Adequate liver function
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
Adequate renal function
Creatinine clearance or glomerular filtration rate >70 ml/min/1.73 m2 or a serum creatinine based on age and gender as follows
Age Maximum serum creatinine concentration (mg/dL) Male Female 1-<2 years 0.6
6 2-<6 years 0.8 0.8 6-<10 years 1 1 10-<13 years 1.2 1.2 13-<16 years 1.5
4 greater than or equal to 16 years 1.7 1.4 The threshold creatinine values
in this table were derived from the Schwartz formula to estimate glomerular
filtration rates (Schwartz et al. J. Peds. 106; 522\. 1985) using child length
and stature data from the CDC
Informed consent: All patients less than 18 years of age must sign a written informed consent. For patients <18 years of age, a parent or guardian must sign a written informed consent, unless the patient is an emancipated minor. Childhood assent, when appropriate, should be obtained as well per institutional guidelines

Exclusion Criteria

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
Allergy or intolerance to any of the protocol agents: vincristine, irinotecan
temozolomide, or vorinostat
Allergy or intolerance to cephalosporins
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
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