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Retinoid
Vorinostat + Isotretinoin + Temozolomide for Glioblastoma
Phase 1 & 2
Waitlist Available
Led By Marta Penas-Prado, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with histologically proven supratentorial WHO grade IV glioma (glioblastoma or gliosarcoma)
Patients must have shown unequivocal evidence for tumor recurrence or progression by MRI scan and should have failed radiation therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed with each 4 week period to accommodate 28 day cycles
Awards & highlights
Study Summary
This trial is testing if vorinostat, given with isotretinoin and temozolomide, can help control glioblastoma or gliosarcoma. The safety of the drug combination will also be studied.
Who is the study for?
Adults over 18 with recurrent WHO grade IV glioma (glioblastoma or gliosarcoma) who've failed radiation therapy can join. They must be able to sign consent, have a Karnofsky performance status >=60, stable health post-prior treatments, and agree to contraception. Exclusions include other cancers within 3 years (except certain types), prior bevacizumab treatment, valproic acid use without switching drugs first, inability to tolerate study procedures or swallow tablets.Check my eligibility
What is being tested?
The trial tests if vorinostat combined with isotretinoin and temozolomide can control recurrent brain tumors in adults and assesses the safety of this drug combination. Participants will undergo surgical resection as needed and receive these medications under careful monitoring for effectiveness and adverse reactions.See study design
What are the potential side effects?
Potential side effects may include blood disorders due to bone marrow suppression; liver function changes; kidney issues; digestive disturbances like nausea or vomiting; fatigue; skin reactions from isotretinoin such as dryness or rash; neurological effects including headaches or seizures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a high-grade brain tumor (glioblastoma or gliosarcoma).
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My cancer has grown or returned after radiation, confirmed by an MRI.
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My cancer growth was confirmed not to be due to previous radiation treatments.
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I am willing to follow the iPLEDGE program for isotretinoin treatment.
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I am 18 years old or older.
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I can care for myself but may need occasional help.
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My blood tests for bone marrow, liver, kidneys, and pancreas are normal, and my cholesterol and triglycerides are under control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed with each 4 week period to accommodate 28 day cycles
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed with each 4 week period to accommodate 28 day cycles
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD)
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
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Ph II: Arm 2Experimental Treatment1 Intervention
Surgical Arm
Group II: Ph I: Arm 3Experimental Treatment3 Interventions
Vorinostat plus isotretinoin plus temozolomide
Group III: Ph I: Arm 2Experimental Treatment2 Interventions
Temozolomide plus isotretinoin
Group IV: Ph I: Arm 1Experimental Treatment2 Interventions
Vorinostat plus isotretinoin
Group V: Ph II: Arm 1Active Control1 Intervention
Non-Surgical
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vorinostat
FDA approved
Isotretinoin
FDA approved
Surgical Resection
2018
Completed Phase 2
~420
Temozolomide
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,646 Total Patients Enrolled
42 Trials studying Glioblastoma
1,834 Patients Enrolled for Glioblastoma
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,436 Total Patients Enrolled
30 Trials studying Glioblastoma
2,916 Patients Enrolled for Glioblastoma
Marta Penas-Prado, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
236 Total Patients Enrolled
1 Trials studying Glioblastoma
178 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My recent MRI was done within the last 17 days and I've been on a stable or decreasing dose of steroids for at least 5 days.I am 18 years old or older.I can care for myself but may need occasional help.I have recovered from side effects of my previous cancer treatments.My blood tests for bone marrow, liver, kidneys, and pancreas are normal, and my cholesterol and triglycerides are under control.I have been treated with temozolomide before.I do not have an active infection, serious illness, or have been treated with HDAC inhibitors.I am not currently taking valproic acid, or I have switched to another medication.I have been treated with carboplatin before.My cancer has grown or returned after radiation, confirmed by an MRI.I have been cancer-free from any other type of cancer for over 3 years.I am taking epilepsy drugs that might interact with my cancer treatment.I have been diagnosed with a high-grade brain tumor (glioblastoma or gliosarcoma).My cancer growth was confirmed not to be due to previous radiation treatments.I've had surgery for a recurring or worsening tumor and have recovered.I am willing to follow the iPLEDGE program for isotretinoin treatment.My condition has worsened up to 2 times after initial improvement.I am not allergic to vorinostat, temozolomide, or isotretinoin.I have previously been treated with isotretinoin.I have never been treated with bevacizumab.
Research Study Groups:
This trial has the following groups:- Group 1: Ph I: Arm 2
- Group 2: Ph I: Arm 3
- Group 3: Ph I: Arm 1
- Group 4: Ph II: Arm 1
- Group 5: Ph II: Arm 2
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
What is the absolute cap on participants for this research endeavor?
"This clinical trial is no longer actively accepting patients, as the most recent edit to its posting was on October 29th 2020. If you are seeking trials for anaplastic gliomas there are currently 707 studies taking part in recruitment, and Vorinostat has 250 active trials that may be of interest."
Answered by AI
What indications are Vorinostat commonly utilized for?
"Vorinostat is often used to regulate advance directives, and can also be beneficial in curbing the progression of disease, nitrosourea treatment, and progressive cutaneous T-cell lymphoma."
Answered by AI
Have there been any additional investigations concerning Vorinostat's efficacy?
"Currently, a total of 250 experiments are evaluating the effects of Vorinostat with 29 trials in their final phase. Although Houston, Texas is home to several studies using this drug, there are 6005 different medical sites conducting investigations on its efficacy worldwide."
Answered by AI
Are there any opportunities currently available for participants to join this trial?
"According to records on clinicaltrials.gov, this trial is not currently searching for candidates. The study was originally opened in November 2007 and last modified October 2020; despite its closure, 957 other trials are actively recruiting patients presently."
Answered by AI
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