Phase 2
N=125
Vorinostat, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Adult Giant Cell Glioblastoma · Adult Glioblastoma · Adult Gliosarcoma
Bottom Line
View on ClinicalTrials.gov: NCT00731731 ↗Enrolled (actual)
125
Serious AEs
61.5%
Results posted
May 2015
Primary outcome: Primary: 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) — 3; 3 number of patients with DLT
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 3-Dimensional Conformal Radiation Therapy (Radiation); Cognitive Assessment (Procedure); Laboratory Biomarker Analysis (Other); Temozolomide (Drug); Vorinostat (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
3; 3 | — |
| PRIMARY Overall Survival at 15 Months (Phase II) |
54.6 | — |
| SECONDARY Incidence of Adverse Events, Based on CTC (Common Toxicity Criteria) Severity Grade |
12; 3; 107 | — |
| SECONDARY Time to Tumor Progression (Phase II) |
8.05 | — |
| SECONDARY Incidence of Adverse Events, as Per NCI CTCAE Version 3.0 (Phase II) |
12; 3; 107 | — |
Summary
This phase I/II trial studies the side effects and best dose of vorinostat when given together with temozolomide and radiation therapy and to see how well they work in treating patients with newly diagnosed glioblastoma multiforme. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving vorinostat together with temozolomide and radiation therapy may kill more tumor cells.
Eligibility Criteria
Inclusion Criteria
- PRE-REGISTRATION:
- 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 = = 60
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Absolute neutrophil count (ANC) >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- White blood cell (WBC) >= 3,000/mm^3
- Hemoglobin >= 10.0 g/dL; Note: this level may be reached by transfusion
- Total bilirubin = = 12 weeks
- Negative serum pregnancy test done = = Class II Congestive Heart Failure
- Inability to take oral medications
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- Congenital long QT syndrome
- Prolonged corrected (QTc) interval (> 450 msec)
- Any of the following Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes =< 7 days prior to registration
- Quinidine, procainamide, disopyramide
- Amiodarone, sotalol, ibutilide, dofetilide
- Erythromycin, clarithromycin
- Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide
- Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
Data sourced from ClinicalTrials.gov (NCT00731731). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.