Vorinostat + Chemotherapy for Cancer
(NYMC195 Trial)
Trial Summary
What is the purpose of this trial?
This trial tests a new mix of four medicines to treat tumors that are hard to treat with usual methods. The goal is to find the safest dose and see if this combination can effectively fight these tough tumors.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot take any other cancer treatments or certain drugs like valproic acid for at least 2 weeks before joining. If you're on corticosteroids for a CNS tumor, your dose must be stable or decreasing for 7 days before starting the trial.
What data supports the effectiveness of the drug Vorinostat in cancer treatment?
Vorinostat, a drug that affects how genes are turned on and off, is already approved for treating T-cell lymphoma and shows potential in treating breast cancer and acute leukemias. It has also been studied in combination with other drugs for non-small cell lung cancer, suggesting it may help in various cancer types.12345
Is vorinostat safe for use in humans?
Vorinostat has been studied in humans, and common side effects include mild to moderate diarrhea, nausea, fatigue, and loss of appetite. More severe side effects can include significant fatigue, low platelet counts, and severe diarrhea, but no deaths related to the drug were reported in the studies.25678
What makes the drug Vorinostat unique for cancer treatment?
Vorinostat is unique because it is a histone deacetylase inhibitor (HDACi) that can regulate gene expression and induce cancer cell death, and it is being explored for use in combination with chemotherapy for various cancers, including breast cancer and acute leukemias. Its mechanism of action and potential to enhance the effects of other cancer drugs make it a novel option compared to standard treatments.12356
Research Team
Jeremy Rosenblum, MD
Principal Investigator
New York Medical College
Eligibility Criteria
This trial is for young patients (1 to 30 years old) with relapsed or refractory solid tumors or CNS malignancies. They must have adequate organ function, not received certain treatments recently, and cannot be pregnant or breastfeeding. Those with uncontrolled infections, allergies to protocol drugs, or recent use of specific inhibitors are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Initial Chemotherapy Cycle
Participants receive vincristine, temozolomide, irinotecan, and cefixime to assess tolerance without vorinostat
Combination Treatment Cycles
Participants receive combination therapy with vorinostat, vincristine, temozolomide, irinotecan, and cefixime
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Vorinostat
Vorinostat is already approved in United States, European Union for the following indications:
- Cutaneous T-cell lymphoma
- Cutaneous T-cell lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
New York Medical College
Lead Sponsor