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NCT00555399

Vorinostat, Isotretinoin and Temozolomide in Adults With Recurrent Glioblastoma Multiforme (GBM)

Terminated Phase 1, PHASE2 Results posted Last updated 22 August 2024
What this trial tests

Phase 1, PHASE2 trial testing Vorinostat in Glioblastoma Multiforme in 55 participants. Terminated before completion.

Timeline
28 November 2007
Primary endpoint
24 January 2020
24 January 2020

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 1, PHASE2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment55
Start date28 November 2007
Primary completion24 January 2020
Estimated completion24 January 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Glioblastoma Multiforme or Anaplastic Glioma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Maximum Tolerated Dose (MTD) Primary · 62 months

To determine the maximum tolerated dose (MTD) of vorinostat + isotretinoin (cRA), carboplatin (CBT) + cRA, and vorinostat + cRA + CBT combinations in adult patients with recurrent glioblastoma multiforme (GBM) and anaplastic gliomas. The units of measurement for the drug dose were either mg/day \[VOR and cRA\] or AUC \[CBT\]. In the outcome measure data table below we have provided the cohort number for each arm at which MTD was declared.

GroupValue95% CI
Arm 1 (MTD Cohort Number)2
Arm 2 (MTD Cohort Number)2
Arm 3A (MTD Cohort Number)4
Arm 3B (MTD Cohort Number)2

Adverse events — posted to ClinicalTrials.gov

Time frame: 65 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm 1 Cohort 1
Serious: 0/3 (0%)
Deaths: 0/3
Arm 1 Cohort 2
Serious: 1/3 (33%)
Deaths: 0/3
Arm 1 Cohort 3
Serious: 0/8 (0%)
Deaths: 0/8
Arm 2 Cohort 1
Serious: 0/6 (0%)
Deaths: 0/6
Arm 2 Cohort 2
Serious: 0/3 (0%)
Deaths: 0/3
Arm 2 Cohort 3
Serious: 0/3 (0%)
Deaths: 0/3
Arm 3A Cohort 1
Serious: 0/5 (0%)
Deaths: 0/5
Arm 3A Cohort 2
Serious: 1/6 (17%)
Deaths: 1/6
Arm 3A Cohort 3
Serious: 0/5 (0%)
Deaths: 0/5
Arm 3A Cohort 4
Serious: 0/3 (0%)
Deaths: 0/3
Arm 3B Cohort 1
Serious: 0/3 (0%)
Deaths: 0/3
Arm 3B Cohort 2
Serious: 1/7 (14%)
Deaths: 1/7

Serious adverse events (2 terms)

ReactionSystemArm 1 Cohort 1Arm 1 Cohort 2Arm 1 Cohort 3Arm 2 Cohort 1Arm 2 Cohort 2Arm 2 Cohort 3Arm 3A Cohort 1Arm 3A Cohort 2Arm 3A Cohort 3Arm 3A Cohort 4Arm 3B Cohort 1Arm 3B Cohort 2
Pulmonary EmbolismVascular disorders
DeathGeneral disorders
Other adverse events (16 terms — click to expand)

ReactionSystemArm 1 Cohort 1Arm 1 Cohort 2Arm 1 Cohort 3Arm 2 Cohort 1Arm 2 Cohort 2Arm 2 Cohort 3Arm 3A Cohort 1Arm 3A Cohort 2Arm 3A Cohort 3Arm 3A Cohort 4Arm 3B Cohort 1Arm 3B Cohort 2
Hemoglobin decreasedBlood and lymphatic system disorders
Cholesterol ElevatedCardiac disorders
FatigueNervous system disorders
Platelets count decreasedBlood and lymphatic system disorders
NauseaGastrointestinal disorders
Dry SkinSkin and subcutaneous tissue disorders
Neutrophil count decreasedBlood and lymphatic system disorders
AnorexiaGastrointestinal disorders
DyspneaCardiac disorders
DiarrheaGastrointestinal disorders
VomittingGastrointestinal disorders
InsomniaNervous system disorders
ALT elevatedMetabolism and nutrition disorders
AST elevatedMetabolism and nutrition disorders
AlopeciaGastrointestinal disorders
NeuropathyNervous system disorders

Most-reported serious reactions: Pulmonary Embolism, Death.

Data from ClinicalTrials.gov NCT00555399 adverse events section.

Sponsor's own description

The goal of this clinical research study is to learn if vorinostat when given with isotretinoin and temozolomide can help to control glioblastoma or gliosarcoma. The safety of these drug combinations will also be studied.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting epigenetic regulators for cancer therapy: mechanisms and advances in clinical trials.
    Cheng Y, He C, Wang M, Ma X, et al · · 2019 · cited 760× · PMID 31871779 · DOI 10.1038/s41392-019-0095-0
  2. Understanding the immunosuppressive microenvironment of glioma: mechanistic insights and clinical perspectives.
    Lin H, Liu C, Hu A, Zhang D, et al · · 2024 · cited 232× · PMID 38720342 · DOI 10.1186/s13045-024-01544-7
  3. Advances in the Knowledge of the Molecular Biology of Glioblastoma and Its Impact in Patient Diagnosis, Stratification, and Treatment.
    Delgado-Martín B, Medina MÁ. · · 2020 · cited 129× · PMID 32382477 · DOI 10.1002/advs.201902971
  4. A Systematic Review of Glioblastoma-Targeted Therapies in Phases II, III, IV Clinical Trials.
    Cruz Da Silva E, Mercier MC, Etienne-Selloum N, Dontenwill M, et al · · 2021 · cited 99× · PMID 33918704 · DOI 10.3390/cancers13081795
  5. The application of histone deacetylases inhibitors in glioblastoma.
    Chen R, Zhang M, Zhou Y, Guo W, et al · · 2020 · cited 93× · PMID 32682428 · DOI 10.1186/s13046-020-01643-6
  6. Glioblastoma at the crossroads: current understanding and future therapeutic horizons.
    Singh S, Dey D, Barik D, Mohapatra I, et al · · 2025 · cited 91× · PMID 40628732 · DOI 10.1038/s41392-025-02299-4
  7. Targeting Histone Deacetylases in Diseases: Where Are We?
    Benedetti R, Conte M, Altucci L. · · 2015 · cited 91× · PMID 24382114 · DOI 10.1089/ars.2013.5776
  8. Advances and challenges in retinoid delivery systems in regenerative and therapeutic medicine.
    Ferreira R, Napoli J, Enver T, Bernardino L, et al · · 2020 · cited 81× · PMID 32848154 · DOI 10.1038/s41467-020-18042-2

Verify or expand the search:

Other trials of Vorinostat

Trials testing the same drug.

Other recruiting trials for Glioblastoma Multiforme

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

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