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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.
Must not have
Allergy or intolerance to any of the protocol agents: vincristine, irinotecan, temozolomide, or vorinostat.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
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.
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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not allergic to vincristine, irinotecan, temozolomide, or vorinostat.
Select...
I do not have any uncontrolled infections or recent positive blood cultures.
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I am not on any cancer treatment drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Vorinostat
Secondary study objectives
Overall response rate (ORR) after therapy
Side effects data
From 2011 Phase 3 trial • 661 Patients • NCT0012810257%
Nausea
47%
Fatigue
43%
Diarrhoea
40%
Vomiting
40%
Decreased appetite
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%
Oedema peripheral
7%
Dizziness
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%
Overdose
1%
Sepsis
1%
Pneumothorax
1%
Confusional state
1%
Bladder cancer
1%
General physical health deterioration
1%
Non-cardiac chest pain
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
71 Previous Clinical Trials
6,124 Total Patients Enrolled
1 Trials studying Neuroblastoma
4 Patients Enrolled for Neuroblastoma
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.
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