Sunitinib in Treating Patients With Recurrent Malignant Gliomas

Status Completed

Clinical Trial Summary

This phase II trial is studying how well sunitinib works in treating patients with recurrent malignant gliomas. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To assess the efficacy of sunitinib malate in patients with recurrent malignant gliomas as measured by 6-month progression-free survival.

II. To determine the lower of the dose of sunitinib malate in patients receiving enzyme-inducing anti-convulsants that would achieve similar serum drug and metabolite concentrations as that in patients not receiving enzyme-inducing anticonvulsants or the maximum tolerated dose in the same population.

SECONDARY OBJECTIVES:

I. To examine the toxicity and safety of sunitinib malate in patients with the above noted tumors.

II. To evaluate tumor responses in the stated patients. III. To evaluate progression-free and overall survival in the stated patients.

OUTLINE: This is a multicenter study. Patients are stratified according to use of enzyme-inducing anticonvulsants (EIAC) (yes vs no).

STRATUM 1 (non-EIAC): Patients receive oral sunitinib malate once daily for 4 consecutive weeks followed by 2 weeks of rest.

STRATUM 2 (EIAC & OSU patients only): Patients receive oral sunitinib malate as in stratum 1. Patients receive escalating doses of oral sunitinib malate until the maximum tolerated dose (MTD) is determined.

Patients undergo blood sample collection periodically for pharmacokinetic studies. Samples are analyzed for plasma concentrations of sunitinib malate via LC/MS/MS method.

In both strata, treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00499473
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Completed
Phase	Phase 2
Start date	June 2007
Completion date	October 2014

View Details

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Withdrawn	`NCT02194452` - Efficacy of 68Ga-DOTATOC Positron Emission Tomography (PET) CT in Children and Young Adults With Brain Tumors	N/A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	`NCT00049387` - Tipifarnib, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma	Phase 1
Completed	`NCT02227901` - Tipifarnib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme	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	`NCT01575275` - Aminolevulinic Acid in Visualizing a Tumor During Surgery in Patients With Glioblastoma Multiforme	Phase 2
Terminated	`NCT01996527` - 3T MRI Biomarkers of Glioma Treatment Response	Early 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	`NCT01119599` - RO4929097, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma	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