A Phase I Study of Vorinostat in Combination With Vincristine, Irinotecan, and Temozolomide in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Tumors and CNS Malignancies
New York Medical College
Summary
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.
Description
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.
Eligibility
- Age range
- 1–30 years
- Sex
- All
- Healthy volunteers
- No
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…