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Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer
Sponsor: National Cancer Institute (NCI)
Summary
This phase I trial studies the side effects and best dose of triapine when given with radiation therapy and cisplatin in treating patients with stage IB2-IVA cervical or vaginal cancer. Triapine may stop the growth of cancer cells by blocking an enzyme needed for cell growth. Cisplatin is a drug used in chemotherapy that kills cancer cells by damaging their deoxyribonucleic acid (DNA) and stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Adding triapine to standard treatment with cisplatin and radiation therapy may kill more cancer cells.
Official title: Phase I Dose-Escalation Bioavailability Study of Oral Triapine in Combination With Concurrent Chemoradiation for Locally Advanced Cervical Cancer (LACC) and Vaginal Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
21
Start Date
2019-09-18
Completion Date
2026-04-29
Last Updated
2025-11-13
Healthy Volunteers
No
Conditions
Interventions
Biospecimen Collection
Undergo collection of blood samples
Brachytherapy
Undergo LDR brachytherapy
Cisplatin
Given IV
Computed Tomography
Undergo FDG-PET/CT
External Beam Radiation Therapy
Undergo pelvic EBRT
Fludeoxyglucose F-18
Undergo FDG-PET/CT
High-Dose Rate Brachytherapy
Undergo HDR brachytherapy
Intensity-Modulated Radiation Therapy
Undergo IMRT
Magnetic Resonance Imaging
Undergo MRI
Pharmacological Study
Correlative studies
Positron Emission Tomography
Undergo FDG-PET/CT
Triapine
Given IV and PO
Locations (17)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Los Angeles General Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Keck Medical Center of USC Pasadena
Pasadena, California, United States
University of Kansas Clinical Research Center
Fairway, Kansas, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States