Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||1 Year - 30 Years|
- - 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.
- - Prior therapy: Patients may have received prior therapy with vincristine, irinotecan, or temozolomide.
- - 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.
- - 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.
- - Adequate liver function: - 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 years 0.8 0.8 6-<10 years 1 1 10-<13 years 1.2 1.2 13-<16 years 1.5 1.4 greater than or equal to 16 years 1.7 1.4 The threshold creatinine values in this table were derived from the Schwartz formula to estimate glomerular filtration rates (Schwartz et al.
- - Informed consent: All patients less than 18 years of age must sign a written informed consent.
- - 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.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|New York Medical College|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Jeremy Rosenblum, MD|
|Principal Investigator Affiliation||New York Medical College|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Ewing Sarcoma, Rhabdomyosarcoma, Wilms Tumor, Neuroblastoma, Hepatoblastoma, Germ Cell Tumor|
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.
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.
Drug: - Vorinostat
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 we can give safely when it is used together with the chemotherapy drugs vincristine, irinotecan and temozolomide. We 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 administered 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. We do not know if this combination of medicines will work in people. There is a lot that we do not yet know about this combination of medicines.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.