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Vorinostat for Giant Cell Glioblastoma

Phase 1 & 2
Waitlist Available
Led By Evanthia Galanis
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Central pathology review submission; this review is mandatory prior to registration to confirm eligibility; it should be initiated as soon after surgery as possible
Treatment should begin >= 2 weeks and =< 5 weeks following surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing vorinostat + temozolomide + radiation therapy to treat glioblastoma multiforme. Vorinostat may stop cell growth by blocking enzymes, while temozolomide and radiation therapy work to kill or stop cell division.

Eligible Conditions
  • Giant Cell Glioblastoma
  • Glioblastoma
  • Gliosarcoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years 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 of Vorinostat, Defined as the Dose at Which Fewer Than One-third of Patients Experience DLTs, Graded According to NCI CTCAE (Common Toxicity Criteria for Adverse Effects) Version 3.0 (Phase I)
Overall Survival at 15 Months (Phase II)
Secondary outcome measures
Incidence of Adverse Events, Based on CTC (Common Toxicity Criteria) Severity Grade
Incidence of Adverse Events, as Per NCI CTCAE Version 3.0 (Phase II)
Time to Tumor Progression (Phase II)

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%
Dehydration
6%
C-reactive protein increased
6%
Musculoskeletal pain
5%
Malaise
4%
Anxiety
4%
Pneumonia
3%
Rash
2%
Atrial fibrillation
2%
Accidental overdose
2%
Pleural effusion
1%
General physical health deterioration
1%
Disseminated intravascular coagulation
1%
Death
1%
Overdose
1%
Pneumothorax
1%
Sepsis
1%
Pericarditis
1%
Ascites
1%
Dysphagia
1%
Non-cardiac chest pain
1%
Bladder cancer
1%
Confusional state
1%
Pulmonary embolism
1%
Deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vorinostat
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (radiation therapy, vorinostat, temozolomide)Experimental Treatment5 Interventions
Patients undergo radiotherapy and receive vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive vorinostat PO QD on days 1-7 and 15-21 and temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7160
Temozolomide
2010
Completed Phase 3
~1930
Vorinostat
2014
Completed Phase 3
~1600
Cognitive Assessment
2011
Completed Phase 2
~1320

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,222 Total Patients Enrolled
9 Trials studying Giant Cell Glioblastoma
338 Patients Enrolled for Giant Cell Glioblastoma
Evanthia GalanisPrincipal InvestigatorAlliance for Clinical Trials in Oncology
8 Previous Clinical Trials
465 Total Patients Enrolled

Frequently Asked Questions

~8 spots leftby Mar 2025