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ACTIVE NOT RECRUITING
NCT02595879
PHASE1

Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

RADIATION

Brachytherapy

Undergo LDR brachytherapy

DRUG

Cisplatin

Given IV

PROCEDURE

Computed Tomography

Undergo FDG-PET/CT

RADIATION

External Beam Radiation Therapy

Undergo pelvic EBRT

OTHER

Fludeoxyglucose F-18

Undergo FDG-PET/CT

RADIATION

High-Dose Rate Brachytherapy

Undergo HDR brachytherapy

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

OTHER

Pharmacological Study

Correlative studies

PROCEDURE

Positron Emission Tomography

Undergo FDG-PET/CT

DRUG

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