Vaccine Therapy in Treating Patients With Persistent or Recurrent Cervical Cancer

Completed · Phase 2

Conditions studied: Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Recurrent Cervical Carcinoma

In brief

This phase II trial studies the side effects and how well vaccine therapy works in treating patients with cervical cancer that does not go to remission despite treatment (persistent) or has come back (recurrent). Vaccines therapy may help the body build an effective immune response to kill tumor cells.

Key facts

Study ID

NCT01266460

Run by

Gynecologic Oncology Group

People needed

54

Starts

2011-05-23

Expected to finish

2018-10-02

Last updated by the study team

2020-09-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have persistent or recurrent squamous or non-squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix with documented disease progression (disease not amenable to curative therapy); histologic confirmation of the original primary tumor is required via the pathology report
• Patient must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded)
• Each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI), or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray
• Lymph nodes must be >= 15 mm in short axis when measured by CT or MRI
• Patient must have at least one ?target lesion? to be used to assess response on this protocol as defined by RECIST 1.1
• Tumors within a previously irradiated field will be designated as ?non-target? lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
• Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists
• In general, this would refer to any active GOG phase III or rare tumor protocol for the same patient population
• Patients must have a GOG performance status of 0 or 1
• Recovered from effects of recent surgery, radiotherapy, or chemotherapy
• Patients should be free of active infection requiring antibiotics
• Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration
• Continuation of hormone replacement therapy is permitted
• Any other prior therapy directed at the malignant tumor, including chemotherapy, biologic/targeted (non-cytotoxic) agents and immunologic agents, must be discontinued at least three weeks prior to registration
• Any prior radiation therapy must be completed at least 4 weeks prior to registration
• Patients must have had one prior systemic chemotherapeutic regimen for management of advanced, metastatic, or recurrent carcinoma of the cervix
• Chemotherapy administered concurrent with primary radiation (e.g.; weekly cisplatin) is not counted as a systemic chemotherapy regimen for management of advanced, metastatic, or recurrent disease; adjuvant chemotherapy given following the completion of radiation therapy (or concurrent chemotherapy and radiation therapy) is not counted as a systemic chemotherapy regimen for management of advanced, metastatic, or recurrent disease (e.g.; paclitaxel and carboplatin for up to 4 cycles)
• Patients are allowed to receive, but are not required to receive, biologic/targeted (non-cytotoxic) therapy as part of their primary therapy and/or as part of their therapy for advanced, metastatic, or recurrent disease (e.g., bevacizumab)
• Platelet count greater than or equal to 75,000/mcL
• Absolute neutrophil count (ANC) count greater than or equal to 1,000/mcL
• Lymphocyte count greater than or equal to 700/mcL
• Hemoglobin count greater than or equal to 9 g/dL or greater than or equal to 5.6 mmol/L
• Note: ANC, platelets, hemoglobin requirement cannot be met by the use of recent transfusions, or growth factor support (granulocyte colony-stimulating factor [G-CSF], erythropoietin, etc.) within 2 weeks prior to treatment initiation
• Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN) or measured or calculated creatinine clearance greater than or equal to 50 mL/min for subject with creatinine levels greater than 1.5 x institutional ULN; (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) (creatinine clearance should be calculated per institutional standard)

You may not qualify if…

• Patients who have received prior therapy with ADXS11-001
• Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted below are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
• Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of cervical cancer within the last three years are excluded
• Prior radiation for localized cancer of the breast, head and neck, or skin is permitted provided that it was completed more than three years prior to registration and the patient remains free of recurrent or metastatic disease
• Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of cervical cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
• Patients with a contraindication (e.g. sensitivity/allergy) to trimethoprim/sulfamethoxazole or ampicillin
• Patients allergic to nonsteroidal antiinflammatory drug (NSAID)
• Patients with active infection requiring systemic therapy or who are dependent on or currently receiving antibiotics that cannot be discontinued before dosing; (Note: subjects who discontinue an antibiotic prior to dosing must wait at least 5 half-lives after the last dose of antibiotic before receiving any ADXS11-001 infusion)
• Patients with a diagnosis of immunodeficiency, or who are dependent on or have received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment with the exception of topical corticosteroids and occasional inhaled corticosteroids, as indicated
• Patients with uncontrolled intercurrent illness including, but not limited to:
• Ongoing or active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia or
• Psychiatric illness/social situations that would limit compliance with study requirements
• Patients with liver cirrhosis or any other impaired hepatic function as determined by serum enzymes
• Patients known to be seropositive for human immunodeficiency virus (HIV) and/or active hepatitis, even if liver function studies are in the eligible range
• Patients with a prior history of a splenectomy and/or sickle cell trait/disease
• Patient has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s)); NOTE: more common devices and prosthetics which include arterial and venous stents, dental and breast implants and venous access devices (e.g., Port-a-Cath or Mediport) are permitted; sponsor must be contacted prior to consenting any subject who has any other device and/or implant
• Any patient currently requiring or anticipated to require tumor necrosis factor (TNF) blocking agent (e.g., infliximab) therapy for diagnosis of rheumatologic disease or inflammatory bowel disease (e.g., ankylosing spondylitis, Crohn disease, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis or ulcerative colitis)
• Patient has undergone a major surgery, including surgery for a new artificial implant and/or device, within 6 weeks prior to the initiation of ADXS11-001 treatment; NOTE: all toxicities and/or complications must have recovered to baseline or grade 1 prior to the initiation of ADXS11-001 study therapy; sponsor must be consulted prior to enrolling patients on the study who recently had a major surgery or have new artificial implant, and/or devices
• Patient has a known allergy to any component of the study treatment formulations
• Patient has a history of listeriosis or prior ADXS11-001 therapy

Where it is running

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
• Saint Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• Los Angeles County-USC Medical Center — Los Angeles, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• UCSF Medical Center-Mount Zion — San Francisco, California, United States
• UCSF Medical Center-Mission Bay — San Francisco, California, United States
• Memorial Health University Medical Center — Savannah, Georgia, United States
• University of Kansas Cancer Center — Kansas City, Kansas, United States
• Sinai Hospital of Baltimore — Baltimore, Maryland, United States
• Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Montefiore Medical Center-Einstein Campus — The Bronx, New York, United States
• Carolinas Medical Center/Levine Cancer Institute — Charlotte, North Carolina, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• UH Seidman Cancer Center at Lake Health Mentor Campus — Mentor, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Oklahoma Cancer Specialists and Research Institute-Tulsa — Tulsa, Oklahoma, United States
• UT Southwestern/Simmons Cancer Center-Dallas — Dallas, Texas, United States
• University of Texas Medical Branch — Galveston, Texas, United States
• Virginia Commonwealth University/Massey Cancer Center — Richmond, Virginia, United States
• Froedtert and the Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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