Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma
Start Date
7/30/2025
Completion Date
6/30/2027
Summary
This phase I trial tests the safety, side effects, and best dose of triapine in combination with radiation therapy in treating patients with glioblastoma or astrocytoma that has come back after a period of improvement (recurrent). Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving triapine in combination with radiation therapy may be safe, tolerable, and/or effective in treating patients with recurrent glioblastoma or astrocytoma.
Detailed Description
PRIMARY OBJECTIVE: I. To identify the safety and maximally tolerated dose (MTD) of oral triapine used in combination with radiation therapy for patients with recurrent glioblastoma (GBM) or astrocytoma. SECONDARY OBJECTIVES: I. To observe and record anti-tumor activity. II. To determine the pharmacokinetics of oral triapine in plasma and the central nervous system (CNS). III. To evaluate the efficacy of triapine when administered in combination with radiation therapy by assessing: IIIa. Progression-free survival (PFS); IIIb. Overall survival (OS); IIIc. The proportion of patients requiring bevacizumab for symptom control; IIId. The correlation of genetic mutations in select genes (e.g., p53, p16, KRAS, and Pi3k/mTOR/AKT) with tumor response and clinical outcomes. OUTLINE: This is a dose-escalation study of triapine in combination with radiation therapy. Patients undergo intensity-modulated radiation therapy (IMRT) once daily (QD) 5 days per week (Monday-Friday) for a total of 10 treatment days over 2 weeks and receive triapine orally (PO) 2 hours prior to IMRT on each radiation treatment day in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the study as well as blood sample collection during screening and on study. Patients may undergo cerebrospinal fluid (CSF) sample collection during screening. After completion of study treatment, patients are followed up at 2 weeks after radiation therapy, then every 3 months for up to 5 years from study treatment initiation.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Biospecimen Collection
Computed Tomography
Intensity-Modulated Radiation Therapy
Magnetic Resonance Imaging
Triapine
Conditions
Locations
City of Hope Comprehensive Cancer Center
Duarte, California 91010
United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California 92612
United States
UC San Diego Moores Cancer Center
La Jolla, California 92093
United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868
United States
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Yale University
New Haven, Connecticut 06520
United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut 06611
United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia 20007
United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida 33146
United States
UM Sylvester Comprehensive Cancer Center at Coral Springs
Coral Springs, Florida 33065
United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida 33442
United States
UM Sylvester Comprehensive Cancer Center at Doral
Doral, Florida 33166
United States
UM Sylvester Comprehensive Cancer Center at Hollywood
Hollywood, Florida 33021
United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
United States
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida 33176
United States
University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
North Miami, Florida 33181
United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida 33324
United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
United States
Northwestern University
Chicago, Illinois 60611
United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois 60637
United States
Memorial Hospital East
Shiloh, Illinois 62269
United States
University of Kansas Clinical Research Center
Fairway, Kansas 66205
United States
University of Kansas Cancer Center
Kansas City, Kansas 66160
United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri 63376
United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Siteman Cancer Center-South County
St Louis, Missouri 63129
United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri 63136
United States
NYU Langone Hospital - Long Island
Mineola, New York 11501
United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York 10016
United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York 10032
United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina 28203
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia 23298
United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin 53718
United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin 53792
United States