BridgeMD
New treatment option for Ewing Sarcoma
Official title Vorinostat in Combination With Chemotherapy in Relapsed/Refractory Solid Tumors and CNS Malignancies
ClinicalTrials.gov ID: NCT04308330
What this study is testing
What is Vorinostat?
Vorinostat is an investigational medicine, being studied as a potential treatment for ewing sarcoma.
Also referred to as Zolinza.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 30
You may be able to join if
- 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...
- Prior therapy: Patients may have received prior therapy with vincristine, irinotecan, or temozolomide. They may not however have received therapy...
- Prior myelosuppressive therapy: Patients must have not received myelosuppressive therapy in 3 weeks or nitrosourea chemotherapy within 6 weeks of...
You likely can't join if
- 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...
- 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...
- 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...
- Infection: Patients who have any uncontrolled infection, positive blood culture within 48 hours prior to protocol entry, or diagnosed or receiving...
- Patients may not have taken valproic acid or any other histone deacetylase inhibitor for at least 2 weeks prior to study enrollment.
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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 0.6 2-\<6...
What rules you out
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Valhalla, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Valhalla, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.