Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT01189266) enrolled a total of 79 participants across three groups. Six people were in a lower-dose testing group (Group 1), six were in a higher-dose testing group (Group 2), and 67 were in the main evaluation group (Group 3). The trial was studying a medicine called vorinostat, given alongside chemotherapy and radiation, and then continued as a maintenance (ongoing) treatment. The trial was looking at what dose of vorinostat could be given, how long participants went without their disease getting worse, and how many experienced serious side effects (defined as grade 3 or higher on a standard medical scale — meaning significant or severe reactions). The reported data shows that the highest dose identified in the early testing phase was 230 mg/m² (a dose calculated based on body surface area). For how long participants went without disease progression — called "event-free survival," expressed as a percentage probability — the reported figures were 0% for Group 1, 0% for Group 2, and 3.1% for Group 3. For overall survival (the probability of still being alive at the end of follow-up), the reported figures were 22% for Group 1, 0% for Group 2, and 3.1% for Group 3. Regarding serious side effects during the combined chemotherapy and radiation phase, 5 of 6, 2 of 6, and 24 of 67 participants were reported to have experienced them across the three groups respectively. During the maintenance phase, those numbers were 6 of 6, 4 of 6, and 39 of 67. For the laboratory measure looking at chemical changes in blood cells (H3 and H4 acetylation levels), no measurement data was reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Brain Cancer Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been newly diagnosed with a type of brain tumor called a diffuse intrinsic pontine glioma (DIPG), meaning the tumor is centered in the brainstem and covers a large portion of it — no biopsy is needed to confirm this type; OR you have a brainstem tumor that has been biopsied and confirmed to be one of certain aggressive types (such as glioblastoma or anaplastic astrocytoma)
- You are well enough to carry out at least some daily activities (measured by a standard health score — confirm with trial site); patients who use a wheelchair but are not bed-bound may still qualify
- You have not received any prior cancer treatment other than a steroid called dexamethasone and/or surgery
- Your blood cell counts are at healthy enough levels — specifically, your infection-fighting white blood cells, platelets, and red blood cells meet the required minimums (confirmed by a blood test)
- Your kidneys are working well enough, based on a blood or urine test appropriate for your age and sex
- Your liver is functioning within acceptable limits, based on blood tests measuring bilirubin, a liver enzyme (ALT), and albumin
- If you have seizures, they are well controlled and you are taking a type of seizure medication that does not interfere with the study drug (not valproic acid)
- You are able to swallow capsules or liquids and do not rely on a feeding tube through your nose
- You are enrolled in the trial within 28 days of your diagnosis by scan or surgery, whichever came later
Who may not be able to join:
- You are pregnant or breastfeeding; girls who have started their periods must take a pregnancy test, and anyone who could become pregnant or father a child must agree to use effective birth control
- You have received medications that boost white blood cell or platelet counts within the 7 days before enrolling
- You are currently taking part in another clinical trial or receiving another experimental drug
- You are currently receiving any other cancer treatment
- You are currently taking certain seizure medications known as "enzyme-inducing anticonvulsants" (confirm with trial site for specific examples)
- You are taking valproic acid (a seizure/mood medication) and have not stopped it for at least 2 weeks before starting the trial
- You are taking blood-thinning medications such as warfarin (coumadin), heparin, or similar drugs
- You are taking more than a low dose of aspirin (over 81 mg/day), anti-inflammatory painkillers (like ibuprofen), or other medications that affect how your blood clots (such as Plavix or Persantine)
- You currently have an infection that is not under control
- In the opinion of the study doctor, you may not be able to safely follow the monitoring requirements of the trial
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Jack M Su, Children's Oncology Group
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Maximum Tolerated Dose (MTD) of Vorinostat; Event-Free Survival; Incidence of Toxicity During Chemoradiation Therapy; Incidence of Toxicity During Maintenance Therapy
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.