Phase II Trial of Treatment Intensification for IDH Wildtype, Non-Histological Glioblastoma, Gliomas (IDH Wildtype Lower Grade Glioma Treatment Intensification)

Who is this study for? Patients with Glioma, Glioblastoma
What treatments are being studied? Quality-of-Life Assessment+Questionnaire Administration+Radiation Therapy+Temozolomide
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This phase II trial studies how well temozolomide and radiation therapy work in treating patients with IDH wildtype historically lower grade gliomas or non-histological molecular glioblastomas. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The goal of this clinical research study is to compare receiving new radiation therapy doses and volumes to the prior standard treatment for patients with historically grade II or grade III IDH wild-type gliomas, which may now be referred to as IDH wildtype molecular glioblastomas at some institutions. Receiving temozolomide in combination with radiation therapy may also help to control the disease.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Historical grade II and III gliomas IDH wildtype gliomas by including; diffuse astrocytoma, anaplastic astrocytoma, oligodendroglioma, anaplastic oligodendroglioma, oligoastrocytoma, anaplastic oligoastrocytoma

• IDH wildtype gliomas (molecularly defined high grade glioma or molecularly defined glioblastoma \[GBM\])

• History \& physical exam, and Karnofsky performance status (KFS) of \>= 70 within 30 days prior to enrollment

• Post-operative magnetic resonance imaging (MRI) with contrast is mandatory and necessary for radiation therapy (RT) planning

• Thin-slice (\< 1.5 mm) three-dimensional (3D) T1 pre and post contrast and axial T2/fluid-attenuated inversion recovery (FLAIR) sequences for planning purposes are highly encouraged to obtain.

• Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3 (within 60 days prior to registration)

• Platelets \>= 100,000 cells/mm\^3 (within 60 days prior to registration)

• Hemoglobin \>= 10.0 g/dl (within 60 days prior to registration) (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 10.0 g/dl is acceptable)

• Bilirubin =\< 1.5 upper limit of normal (ULN) (within 60 days prior to registration)

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN (within 60 days prior to registration)

• Blood urea nitrogen (BUN) \< 30 mg/dl (within 60 days prior to registration)

• Serum creatinine \< 1.5 mg/dl (within 60 days prior to registration)

Locations
United States
Texas
M D Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Debra N Yeboa
dnyeboa@mdanderson.org
713-563-2300
Time Frame
Start Date: 2020-01-30
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 40
Treatments
Experimental: Treatment (temozolomide, radiation therapy)
Patients receive temozolomide PO daily and radiation therapy over 5 days a week (weekdays only) for 6 weeks. Beginning 28 days after the last dose of radiation therapy, patients receive temozolomide PO for 12 months in the absence of disease progression or unacceptable toxicity.
Sponsors
Leads: M.D. Anderson Cancer Center

This content was sourced from clinicaltrials.gov