Clinical Trials Logo

Clinical Trial Summary

This phase I trial is studying the side effects and best dose of vorinostat when given together with temozolomide in treating patients with malignant gliomas. Drugs used in chemotherapy, such as vorinostat and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vorinostat may help temozolomide work better by making tumor cells more sensitive to the drug. Giving vorinostat together with temozolomide may kill more tumor cells.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of vorinostat (suberoylanilide hydroxamic acid [SAHA]) in combination with temozolomide in patients with malignant gliomas. II. To characterize the safety profile of vorinostat (SAHA) in combination with temozolomide. SECONDARY OBJECTIVES: I. To characterize the pharmacokinetics of vorinostat (SAHA) in combination with temozolomide. II. To determine efficacy of vorinostat (SAHA) in combination with temozolomide as measured by objective response. TERTIARY OBJECTIVES: I. To explore the association of response to treatment to the molecular phenotype of the tumor. II. To assess the effects of vorinostat (SAHA) on histone acetylation status in peripheral mononuclear cells. OUTLINE: This is a 2-part, dose-escalation study of vorinostat. PART I: Patients receive vorinostat orally (PO) once (QD) or twice daily (BID) on days 1-7 and 15-21 OR QD or BID on days 1-7. Patients also receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. Beginning in course 2, some patients may receive a higher dose of temozolomide. Treatment may continue beyond 13 courses at the discretion of the investigator. PART II: Patients receive vorinostat and temozolomide as in part 1*. [Note: *Beginning in course 2, all patients receive a higher dose of temozolomide.] After completion of study treatment, patients are followed up periodically. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00268385
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Active, not recruiting
Phase Phase 1
Start date December 16, 2005
Completion date April 24, 2025

See also
  Status Clinical Trial Phase
Terminated NCT02530502 - Radiation Therapy With Temozolomide and Pembrolizumab in Treating Patients With Newly Diagnosed Glioblastoma Phase 1
Withdrawn NCT02194452 - Efficacy of 68Ga-DOTATOC Positron Emission Tomography (PET) CT in Children and Young Adults With Brain Tumors N/A
Completed NCT00238303 - Vorinostat in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme Phase 2
Completed NCT02227901 - Tipifarnib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Phase 1
Completed NCT00049387 - Tipifarnib, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma Phase 1
Completed NCT02015819 - Genetically Modified Neural Stem Cells, Flucytosine, and Leucovorin for Treating Patients With Recurrent High-Grade Gliomas Phase 1
Active, not recruiting NCT02179086 - Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Phase 2
Recruiting NCT04573140 - A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM) Phase 1
Active, not recruiting NCT00823797 - Bendamustine Hydrochloride in Treating Patients With Recurrent or Progressive Anaplastic Glioma Phase 2
Completed NCT00045565 - Arsenic Trioxide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma Phase 1
Completed NCT01977677 - Plerixafor After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed High Grade Glioma Phase 1/Phase 2
Completed NCT01648348 - Bevacizumab With or Without Anti-Endoglin Monoclonal Antibody TRC105 in Treating Patients With Recurrent Glioblastoma Multiforme Phase 1/Phase 2
Completed NCT00004262 - Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme Phase 1
Terminated NCT01996527 - 3T MRI Biomarkers of Glioma Treatment Response Early Phase 1
Terminated NCT01575275 - Aminolevulinic Acid in Visualizing a Tumor During Surgery in Patients With Glioblastoma Multiforme Phase 2
Completed NCT01119599 - RO4929097, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma Phase 1
Terminated NCT01103375 - Erlotinib Hydrochloride and Isotretinoin in Treating Patients With Recurrent Malignant Glioma Phase 1
Completed NCT01131234 - Gamma-Secretase Inhibitor RO4929097 and Cediranib Maleate in Treating Patients With Advanced Solid Tumors Phase 1
Completed NCT00459381 - Pazopanib in Treating Patients With Recurrent Glioblastoma Phase 2
Completed NCT00316849 - Temsirolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Phase 1