NCT02595879Active, not recruitingPhase 1
Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer
Phase I Dose-Escalation Bioavailability Study of Oral Triapine in Combination With Concurrent Chemoradiation for Locally Advanced Cervical Cancer (LACC) and Vaginal Cancer
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 3 Nov 2015
- Start date
- 18 Sept 2019
- Primary completion date
- 4 Jun 2023
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Cervical cancer
- NCT number
- NCT02595879
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 21
- From 18 Sept 2019 to the primary completion date, 4 Jun 2023
- 17 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients are excluded if they have received prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues at the discretion of the treating physician
- Patients receiving any other investigational agents
- Patients who are taking any medication associated with methemoglobinemia; medication must be discontinued and must have a washout period of 4 halflives or 4 weeks, whichever is shorter
- Patients scheduled to be treated with adjuvant consolidation chemotherapy at the conclusion of their standard chemoradiation
Other illness
- Patient has had a prior invasive malignancy diagnosed within the last three years (except \[1\] non-melanoma skin cancer or \[2\] prior in situ carcinoma of the cervix)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to triapine or cisplatin
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; known inadequately controlled hypertension; significant pulmonary disease including dyspnea at rest, patients requiring supplemental oxygen, or poor pulmonary reserve; or psychiatric illness/social situations that would limit compliance with study requirements
- Patients who have had a hysterectomy or are planning to have an adjuvant hysterectomy following radiation as part of their cervical cancer treatment are ineligible
Lab values
- Patients with known glucose-6-phosphate dehydrogenase deficiency (G6PD) are excluded due to an inability to administer the antidote for methemoglobinemia, methylene blue; pre-registration testing for G6PD is at the investigator's discretion and is not required for study enrollment
- Patients with uncontrolled diabetes mellitus (fasting blood glucose controlled by medication, =\< 200 mg/dL allowed)
Who the study is looking for
- Patient has a new, untreated histologic diagnosis of stage IB2 (\> 5 cm), II, IIIB, IIIC or IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix or stage II-IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the vagina not amenable to curative surgical resection alone; the presence or absence of lymph node metastasis will be based on pre-therapy 18F-FDG PET/CT; the patient must be able to tolerate imaging requirements of an 18F-FDG PET/CT scan
- Age \>= 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- Life expectancy greater than 6 months
- Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L
- Platelets \>= 100 x 10\^9/L
- Hemoglobin (Hgb) \>= 10.0 g/dL (blood transfusions to reach this amount are allowed)
- Serum creatinine =\< 1.5 mg/dL to receive weekly cisplatin
- If serum creatinine is between 1.5 and 1.9 mg/dL, patients are eligible for cisplatin if the estimated creatinine clearance (CCr) is \> 30 ml/min (for the purpose of estimating the CCr, the formula of Cockcroft and Gault for females should be used)
- Total serum bilirubin =\< 1.5 x upper limit of normal (ULN) (in patients with known Gilbert syndrome, a total bilirubin =\< 3.0 x ULN, with direct bilirubin =\< 1.5 x ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN
- Able to take oral medication
- Not pregnant and not breastfeeding; the effects of triapine on the developing human fetus are unknown; for this reason as well as because heterocyclic carboxaldehydethiosemicarbazones and radiation are known to be teratogenic, women of child-bearing potential and men must agree to use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; patient must have documented negative urine pregnancy test must be resulted within 7 days before initiating protocol therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with triapine, breastfeeding should be discontinued if the mother is treated with triapine; these potential risks may also apply to other agents used in this study
- For HIV and hepatitis B/C (HEPB/C):
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for the dose escalation portion of this trial; for those patients who are enrolled in the HIV positive (+) expansion cohort, they must be HIV infected and be on retroviral therapy with an undetectable viral load within 6 months of enrollment
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured; for patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Able to understand and willingness to sign a written informed consent document
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Rogel Cancer Center Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| University of Alabama at Birmingham Cancer Center Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| University of Virginia Cancer Center Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Wayne State University/Karmanos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| University of Kansas Clinical Research Center Coordinator of this site? Confirm its status | Fairway | United States | Unknown status |
| Weisberg Cancer Treatment Center Coordinator of this site? Confirm its status | Farmington Hills | United States | Unknown status |
| University of Kansas Cancer Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| University of Kentucky/Markey Cancer Center Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Los Angeles General Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Rutgers Cancer Institute of New Jersey Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| University of Kansas Hospital-Indian Creek Campus Coordinator of this site? Confirm its status | Overland Park | United States | Unknown status |
| Keck Medical Center of USC Pasadena Coordinator of this site? Confirm its status | Pasadena | United States | Unknown status |
| UPMC Hillman Cancer Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| VCU Massey Comprehensive Cancer Center Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| University of Kansas Hospital-Westwood Cancer Center Coordinator of this site? Confirm its status | Westwood | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.