Overview

Chemoradiation Therapy and Ipilimumab in Treating Patients With Stages IB2-IIB or IIIB-IVA Cervical Cancer

Status:
Completed
Trial end date:
2020-07-17
Target enrollment:
0
Participant gender:
Female
Summary
This phase I trial studies the side effects and best dose of ipilimumab when given after chemoradiation therapy in treating patients with stages IB2-IIB or IIIB-IVA cervical cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Monoclonal antibodies, such as ipilimumab, may find tumor cells and help carry tumor-killing substances to them. Giving ipilimumab together with chemoradiation therapy may be a better way treat cervical cancer.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute (NCI)
Collaborator:
NRG Oncology
Treatments:
Antibodies, Monoclonal
Cisplatin
Ipilimumab
Succinylcholine
Criteria
Inclusion Criteria:

- Patients with histologically confirmed advanced cervical cancer (squamous cell
carcinoma, adenocarcinoma, and adenosquamous cell carcinoma): International Federation
of Gynecology and Obstetrics (FIGO) clinical stages IB2/IIA with positive para-aortic
lymph nodes or FIGO clinical stages IIB/IIIB/IVA with positive pelvic and/or
para-aortic lymph nodes; nodal status will be confirmed by PET/CT scan, fine needle
biopsy, extra peritoneal biopsy, laparoscopic biopsy or lymphadenectomy

- Patients must have a Gynecologic Oncology Group (GOG) performance status of 0-1

- Absolute neutrophil count (ANC) >= 1,500/mcl

- Platelets >= 100,000/mcl

- Creatinine =< institutional upper limit normal (ULN); note: if creatinine > ULN,
creatinine clearance must be > 50 mL/min

- Bilirubin =< 1.5 x ULN

- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and
alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x
ULN

- Alkaline phosphatase =< 2.5 x ULN

- Neuropathy (sensory and motor) =< grade 1

- Patients with ureteral obstruction (i.e., hydronephrosis identified on CT imaging)
must undergo stent or nephrostomy tube placement prior to study entry

- Patients must meet the pre-entry requirements specified

- Patients must have signed an approved informed consent and authorization permitting
the release of personal health information

- Patients of child-bearing potential must have a negative serum pregnancy test prior to
study entry (within 72 hours prior to initiation of study treatment) and be practicing
an effective form of contraception; women should not breast-feed while on this study

- Patients must not be receiving any other investigational agent

- Patients should have an audiogram at baseline, and patients with pre-existing hearing
loss or hearing loss during treatment should be assessed frequently during cisplatin
therapy

Exclusion Criteria:

- Patients who have received previous pelvic or abdominal radiation, cytotoxic
chemotherapy, or previous therapy of any kind for this malignancy or any pelvic or
abdominal radiation for any prior malignancy

- Patients with active infection

- Patients who have circumstances that will not permit completion of this study or the
required follow-up

- Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal
transplantation, that would require modification of radiation fields

- 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 prevents full delivery of this protocol therapy

- Patients who have undergone major surgery, excluding diagnostic biopsy, within 30 days
(to allow for full recovery) prior to registration

- Patients who have a significant history of cardiac disease, i.e., uncontrolled
hypertension, unstable angina, congestive heart failure, or uncontrolled arrhythmias
within 6 months of registration

- Patients with a history of prior treatment with ipilimumab, anti-programmed cell death
(PD) 1 antibody, cluster of differentiation (CD)137 agonist or other immune activating
therapy such as anti-CD 40 antibody

- Patients who are receiving any other investigational agents

- Autoimmune disease: patients with a history of inflammatory bowel disease, including
ulcerative colitis and Crohn's disease, are excluded from this study, as are patients
with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic
progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune
vasculitis [e.g., Wegener's Granulomatosis]); central nervous system (CNS) or motor
neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and
myasthenia gravis, multiple sclerosis)

- Patients with known immune impairment who may be unable to respond to anti-cytotoxic
T-lymphocyte-associated protein 4 (CTLA 4) antibody

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition ipilimumab or other agents used in study

- Patients with chronic human immunodeficiency virus (HIV), hepatitis B or hepatitis C
infections should be excluded