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

Study acronym: NYMC195
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 31, 2023 to Dec 31, 2026
    • Study completion date: Dec 31, 2024 to Dec 31, 2027
    v6
  2. Re-verified, no change to tracked fieldsv5
  3. Primary completion date: Dec 17, 2021 to Dec 31, 2023
    • Study completion date: Dec 17, 2022 to Dec 31, 2024
    v4
  4. 2 versions Re-verified since Aug 4, 2020, no change to tracked fieldsv2-v3
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04308330
Lead Sponsor New York Medical College
Conditions
(from sponsor)		 Ewing Sarcoma, Rhabdomyosarcoma, Wilms Tumor, Neuroblastoma, Hepatoblastoma, Germ Cell Tumor
Related terms Hepatoblastoma, Neoplasms, Germ Cell and Embryonal, Neuroblastoma, Rhabdomyosarcoma, Sarcoma, Ewing, Wilms Tumor
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov