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NCT00555399 · ClinicalTrials.gov registry record · Phase 1
Vorinostat, Isotretinoin and Temozolomide in Adults With Recurrent Glioblastoma Multiforme (GBM)
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT00555399: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00555399 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 55 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00555399, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- PROCEDURE Surgical Resection
- DRUG Temozolomide
- DRUG Vorinostat
- DRUG Isotretinoin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2007-11-28 |
| Est. Completion | 2020-01-24 |
| Phase | Phase 1 |
Why NCT00555399 stopped before completion
NCT00555399 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Surgical Resection is the first listed.
NCT00555399 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00555399 about?
NCT00555399 is a clinical study titled "Vorinostat, Isotretinoin and Temozolomide in Adults With Recurrent Glioblastoma Multiforme (GBM)". 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.
What is the current status of trial NCT00555399?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2007-11-28. Estimated completion is 2020-01-24.
What interventions are being tested in trial NCT00555399?
The interventions under investigation include: Surgical Resection (PROCEDURE), Temozolomide (DRUG), Vorinostat (DRUG), Isotretinoin (DRUG).
Who is sponsoring clinical trial NCT00555399?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00555399's enrollment target sits among peer trials
55 918th of 2000 higher than 1,070 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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