Clinical Research Trials

Key Trial Criteria

• Key Inclusion Criteria

  For a patient to be eligible for participation in this study, all of the following criteria must apply.

  • Patient has a new, unrated histologic diagnosis of stage IB2 (> 5 cm), II, IIIB 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 para‐aortic lymph node metastasis will be based on pre-therapy 18F‐FDG PET/CT; if the baseline 18F‐FDG PET/CT identifies hypermetabolic para‐aortic disease, such patients will NOT be eligible; the patient must be able to tolerate imaging requirements of an 18F‐FDG PET/CT scan
  • Patient must provide study specific informed consent prior to study entry
  • Patient must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2 or equivalent
  • Absolute neutrophil count > 1,500/uL
  • Platelets > 100,000/uL
  • Hemoglobin > 10 g/dL
  • Total bilirubin < 2.0 mg/dL
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 X institutional upper limit of normal
  • Prothrombin time (PT)/activated partial thromboplastin time (aPTT) < 1.5 X institutional upper limit of normal
  • Creatinine =< 1.5 mg/dL to receive weekly cisplatin
    • Patients whose serum creatinine is between 1.5 and 1.9 mg/dL 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
  • Patient does not have uncontrolled diabetes mellitus (i.e., fasting blood glucose > 200 mg/dL)
  • Patient has a life expectancy of greater than 20 weeks
  • Patient does not have known brain metastases (testing optional)
  • Patient does not have known human immunodeficiency virus syndrome (HIV, testing optional); known HIV-positive patients receiving combination antiretroviral therapy are ineligible
  • Patient does not have a known allergy to compounds of similar or biologic composition as triapine
  • Patient does not have known glucose‐6‐phosphate dehydrogenase (G6PD) deficiency (G6PD testing optional)
  • Patient is not actively breastfeeding (or has agreed to discontinue breastfeeding before the initiation of protocol therapy)

• Key Exclusion Criteria

  A patient will not be eligible for participation in this study if any of the following criteria apply.

  • Patients with recurrent carcinoma of the vulva regardless of previous treatment
  • Patients who have received prior pelvic radiation or cytotoxic chemotherapy
  • Patients with vulvar melanomas or sarcomas
  • Patients with circumstances that will not permit completion of the study or the required follow-up
  • Patients with evidence of active septicemia, severe infection, gastrointestinal bleeding or severe gastrointestinal symptoms requiring medical or surgical therapy
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy