Overview

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

Status:
Recruiting
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute (NCI)
Treatments:
Cisplatin
Succinylcholine
Criteria
Inclusion Criteria:

- 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 para-aortic
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

- 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 human immunodeficiency virus (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

Exclusion Criteria:

- 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)

- 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 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

- 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 with uncontrolled diabetes mellitus (fasting blood glucose controlled by
medication, =< 200 mg/dL allowed)

- 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

- Patients scheduled to be treated with adjuvant consolidation chemotherapy at the
conclusion of their standard chemoradiation