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

Part of paid clinical trials in Valhalla, New York.

Sponsor
New York Medical College
Study ID
NCT04308330
Phase
PHASE1
Status
Recruiting
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Conditions

  • Ewing Sarcoma
  • Germ Cell Tumor
  • Hepatoblastoma
  • Neuroblastoma
  • Rhabdomyosarcoma
  • Wilms Tumor

Eligibility Criteria

Sex
ALL
Age
1 Year - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Vorinostat — DRUG
    This is a phase I study of the combination of four drugs: vorinostat, vincristine, irinotecan, and temozolomide. This is called a Phase I study because the goal is to find the highest dose of vorinostat that investigators can give safely when it is used together with the chemotherapy drugs vincristine, irinotecan and temozolomide. Investigators are using vorinostat because it seems to work against cancer in test tubes and animals. It may be most effective when it is given with chemotherapy. The combination of these three agents together has never been given to children. Vincristine, irinotecan, and temozolomide are approved and used for the treatment of other types of cancer in adults and children. Vorinostat is approved and used to treat cancer in adults. The combination of these four drugs together is experimental. Investigators do not know if this combination of medicines will work in people. There is a lot that investigators do not yet know about this combination of medicines.

Study Details

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.

Key Dates

Start date
Mar 17, 2017
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Vorinostat
    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.

Primary Outcome Measure

To determine a maximally tolerated (or optimal) dose of vorinostat [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
New York Medical CollegeValhallaNew York10595
Harshini Mahanti, BS
Jeremy Rosenblum, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Valhalla, NY

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By specialty
OncologyPediatric oncology
By research site
New York Medical College· Valhalla, NY

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