Telaglenastat With Radiation Therapy and Temozolomide in Treating Patients With IDH-Mutated Diffuse Astrocytoma or Anaplastic Astrocytoma (NCT03528642)
🩺 Plain-English Summary (8th-Grade Level)
This phase 1b trial studies the side effects and best dose of telaglenastat in combination with radiation therapy and temozolomide in treating patients with IDH-mutated diffuse or anaplastic astrocytoma. Telaglenastat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, 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. Giving telaglenastat with radiation therapy and temozolomide may work better than surgery, radiation therapy, and temozolomide in treating patients with IDH-mutated diffuse astrocytoma or anaplastic astrocytoma.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (25 items) and avoid the listed exclusions (15 items).
Location: Mayo Clinic Hospital in Arizona — Phoenix, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patients must not have received prior chemotherapy to treat the glioma.
- Patients who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to telaglenastat (CB-839) HCl or TMZ.
- Patient must not have received prior radiation therapy to the brain. Prior radiation therapy to the head and neck is also excluded if radiation fields overlap.
- No prior use of Gliadel wafers.
- Patient must have no evidence of either infratentorial or spinal involvement with tumor.
- Patients who are unable to swallow tablets.
- Patients who are at risk for impaired absorption of oral medication including, but not limited to, refractory vomiting, gastric resection/bypass, and duodenal/jejunal resection.
- Patients with uncontrolled intercurrent illness.
- Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for more than 3 years.
- Pregnant women are excluded from this study because telaglenastat (CB-839) HCl is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with telaglenastat (CB-839) HCl, breastfeeding should be discontinued if the mother is treated with telaglenastat (CB-839) HCl. These potential risks may also apply to TMZ.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (25 Sites)
- Mayo Clinic Hospital in Arizona — Phoenix, Arizona
- Mayo Clinic in Arizona — Scottsdale, Arizona
- UC San Diego Moores Cancer Center — La Jolla, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California
- Sibley Memorial Hospital — Washington D.C., District of Columbia
- Mayo Clinic in Florida — Jacksonville, Florida
- Moffitt Cancer Center — Tampa, Florida
- University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa
- University of Kentucky/Markey Cancer Center — Lexington, Kentucky
- Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland
- Dana-Farber Cancer Institute — Boston, Massachusetts
- University of Michigan Rogel Cancer Center — Ann Arbor, Michigan
- Mayo Clinic in Rochester — Rochester, Minnesota
- Siteman Cancer Center at Saint Peters Hospital — City of Saint Peters, Missouri
- Siteman Cancer Center at West County Hospital — Creve Coeur, Missouri
- Washington University School of Medicine — St Louis, Missouri
- Siteman Cancer Center-South County — St Louis, Missouri
- Siteman Cancer Center at Christian Hospital — St Louis, Missouri
- Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York, New York
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center — New York, New York
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania
- UT MD Anderson Cancer Center — Houston, Texas
- Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah
- University of Virginia Cancer Center — Charlottesville, Virginia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.