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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~assessed with each 4 week period to accommodate 28 day cycles
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed with each 4 week period to accommodate 28 day cycles for reporting.

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 • NCT00128102
57%
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
2,986 Previous Clinical Trials
1,789,379 Total Patients Enrolled
42 Trials studying Glioblastoma
1,834 Patients Enrolled for Glioblastoma
Merck Sharp & Dohme LLCIndustry Sponsor
3,906 Previous Clinical Trials
5,064,683 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

Isotretinoin (Retinoid) Clinical Trial Eligibility Overview. Trial Name: NCT00555399 — Phase 1 & 2
Glioblastoma Research Study Groups: Ph I: Arm 2, Ph I: Arm 3, Ph I: Arm 1, Ph II: Arm 1, Ph II: Arm 2
Glioblastoma Clinical Trial 2023: Isotretinoin Highlights & Side Effects. Trial Name: NCT00555399 — Phase 1 & 2
Isotretinoin (Retinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00555399 — Phase 1 & 2
~8 spots leftby May 2025
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