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Histone Deacetylase Inhibitor
Vorinostat + Chemotherapy for Cancer (NYMC195 Trial)
Phase 1
Recruiting
Led By Jeremy Rosenblum, MD
Research Sponsored by New York Medical College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No active graft vs. host disease or need for immunosuppressive therapy. At least 3 months must have passed since neutrophil engraftment.
≥ 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
NYMC195 Trial Summary
This trial is testing a new experimental drug combination in the hopes of finding a more effective treatment against tumors.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests the highest safe dose of vorinostat combined with vincristine, irinotecan, and temozolomide in children and young adults. It aims to determine side effects, impact on tumor cell molecules, and overall treatment effectiveness against stubborn tumors.See study design
What are the potential side effects?
Possible side effects include reactions related to each drug in the combination: vorinostat may cause fatigue and gastrointestinal issues; vincristine can lead to nerve damage; irinotecan might result in diarrhea; temozolomide could cause blood disorders.
NYMC195 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I don't have active graft vs. host disease and haven't needed immunosuppressive therapy for over 3 months.
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It's been over 14 days since my last radiation therapy, or longer for specific types.
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My platelet count is above 100,000/mcL without transfusions in the last week.
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I am over 16 and can do most of my daily activities on my own.
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My bilirubin levels are within the normal range for my age.
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My cancer has returned or didn't respond to treatment and affects either my body or brain.
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My kidney function is good based on tests.
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I am between 1 and 30 years old starting the treatment.
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My child is under 16 and can do most activities without help.
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I haven't had bone marrow-suppressing treatment in the last 3 weeks or specific chemotherapy in the last 6 weeks.
NYMC195 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Vorinostat
Secondary outcome measures
Overall response rate (ORR) after therapy
Side effects data
From 2011 Phase 3 trial • 661 Patients • NCT0012810257%
Nausea
47%
Fatigue
43%
Diarrhoea
40%
Decreased appetite
40%
Vomiting
29%
Dyspnoea
24%
Constipation
20%
Weight decreased
18%
Tumour pain
18%
Cough
15%
Pleural mesothelioma malignant advanced
14%
Anaemia
12%
Pyrexia
9%
Insomnia
9%
Dry mouth
9%
Blood creatinine increased
9%
Abdominal pain
8%
Back pain
8%
Dysgeusia
7%
Dizziness
7%
Oedema peripheral
7%
Thrombocytopenia
7%
Headache
6%
C-reactive protein increased
6%
Dehydration
6%
Musculoskeletal pain
5%
Malaise
4%
Pneumonia
4%
Anxiety
3%
Rash
2%
Atrial fibrillation
2%
Accidental overdose
2%
Pleural effusion
1%
Sepsis
1%
Overdose
1%
Bladder cancer
1%
Pneumothorax
1%
Non-cardiac chest pain
1%
Confusional state
1%
General physical health deterioration
1%
Pericarditis
1%
Disseminated intravascular coagulation
1%
Death
1%
Ascites
1%
Dysphagia
1%
Pulmonary embolism
1%
Deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vorinostat
Placebo
NYMC195 Trial Design
1Treatment groups
Experimental Treatment
Group I: VorinostatExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vorinostat
2014
Completed Phase 3
~1600
Find a Location
Who is running the clinical trial?
New York Medical CollegeLead Sponsor
69 Previous Clinical Trials
6,031 Total Patients Enrolled
Jeremy Rosenblum, MDPrincipal InvestigatorNew York Medical College
2 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have enough infection-fighting white blood cells in your body.It's been over 14 days since my last radiation therapy, or longer for specific types.Your hemoglobin level is 8 gm/dL or higher.I am not allergic to vincristine, irinotecan, temozolomide, or vorinostat.My child has neurofibromatosis Type 1 and is being treated for a low grade brain tumor.Your blood albumin level is at least 2 gm/dL.I am under 18 and have consent from a parent or guardian, or I am an emancipated minor.I don't have active graft vs. host disease and haven't needed immunosuppressive therapy for over 3 months.I haven't taken valproic acid or similar drugs in the last 2 weeks.You are allergic or have a bad reaction to cephalosporin antibiotics.It's been over 21 days since my last cancer drug treatment.I haven't taken G-CSF in the last 3 days or peg-filgrastim in the last 7 days.Your liver enzyme level (SGPT/ALT) should be less than or equal to 5 times the upper limit of normal.I haven't been on a stable or decreasing dose of corticosteroids for the last 7 days.My platelet count is above 100,000/mcL without transfusions in the last week.I am over 16 and can do most of my daily activities on my own.My bilirubin levels are within the normal range for my age.My cancer has returned or didn't respond to treatment and affects either my body or brain.I do not have any uncontrolled infections or recent positive blood cultures.My kidney function is good based on tests.I have previously been treated with vincristine, irinotecan, or temozolomide.I am between 1 and 30 years old starting the treatment.My child is under 16 and can do most activities without help.I haven't had bone marrow-suppressing treatment in the last 3 weeks or specific chemotherapy in the last 6 weeks.I am not on any cancer treatment drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Vorinostat
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have the researchers recruited to participate in this trial?
"Affirmative. The information on clinicaltrials.gov suggests that this study, which was initially posted in March of 2017 and recently updated in October of 2022, is currently recruiting individuals to join with 30 needed from a single site."
Answered by AI
Are there any previous investigations concerning Vorinostat?
"As we speak, there are 32 live clinical trials that use Vorinostat as an intervention. Of these ongoing studies, 2 have reached the pivotal Phase 3 stage. The research hub is based in Bethesda, Maryland but nearly 800 different locations around the world are running tests for this drug."
Answered by AI
What are the eligibility requirements for participation in this clinical experiment?
"This medical trial is enrolling 30 participants under the age of thirty and one year old, who have been diagnosed with hepatoblastoma. Furthermore, patients must adhere to specific criteria including: Hematologic growth factor support (no G-CSF within 3 days or peg-filgrastim in 7 days), Age (< 1yr & <30yrs at initiation of protocol therapy), Diagnosis (relapsed/refractory solid tumor or CNS malignancy), Performance status (>50 Karnofsky for >16 yo; >50 Lansky for younger entrants) , Prior Therapy (vincristine, irinotec"
Answered by AI
What adverse effects have been linked to the utilization of Vorinostat?
"There is limited clinical evidence to support Vorinostat's safety and efficacy, thus it was graded a 1 on our scale."
Answered by AI
Does this research experiment accept participants of a certain age demarcation?
"According to the study's criteria, only individuals aged 1-30 are eligible for enrollment. Clinicaltrials.gov shows there are 503 trials available for patients younger than 18 and 2296 studies aimed at seniors over 65 years old."
Answered by AI
Are new participants currently being enrolled for this research endeavor?
"According to records on clinicaltrials.gov, the recruitment process is ongoing for this trial that was initially posted March 17th 2017 and most recently edited October 24th 2022."
Answered by AI
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