AzTrials
AzTrials

Cervical AdenocarcinomaPhase 2NCT01266460

Vaccine Therapy in Treating Patients With Persistent or Recurrent Cervical Cancer

A Phase 2 study testing Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001 and Laboratory Biomarker Analysis in people with Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma, run by Gynecologic Oncology Group at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001 and Laboratory Biomarker Analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
24 sitesUnited States
Study dates
23 May 2011to 2 Oct 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 35Show fewer
  • 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)
  • Total bilirubin less than or equal to 1.5 x ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 x ULN
  • Alkaline phosphatase less than or equal to 2.5 x ULN
  • International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) less than or equal to 1.5 x ULN, unless patient is receiving anticoagulant therapy as long as PT or INR is within therapeutic range of intended use of anticoagulants
  • Neuropathy (sensory and motor) less than or equal to grade 1
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • Patients must meet pre-entry requirements as specified
  • Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and must agree to ongoing use of 2 methods of study doctor approved birth control or abstain from heterosexual activity for the course of the study from screening through 120 days after the last dose of study medication; patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year
  • Patients cannot be lactating
  • Patients must be able to swallow pills

Who cannot join

  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Los Angeles County-USC Medical Center

    Los Angeles, California, 90033

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • UH Seidman Cancer Center at Lake Health Mentor Campus

    Mentor, Ohio, 44060

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Saint Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • UCSF Medical Center-Mount Zion

    San Francisco, California, 94115

  • UCSF Medical Center-Mission Bay

    San Francisco, California, 94158

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461

  • Oklahoma Cancer Specialists and Research Institute-Tulsa

    Tulsa, Oklahoma, 74146

Other trials in United States

About this study

Official title: A Phase II Evaluation of ADXS11-001 (NSC 752718) in the Treatment of Persistent or Recurrent Squamous or Non-Squamous Cell Carcinoma of the Cervix

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the tolerability, safety, and nature and degree of toxicity of ADXS11-001 (live-attenuated Listeria monocytogenes cancer vaccine ADXS11-001) by the numbers of patients with dose-limiting toxicities (DLTs) and adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0.

II. To assess the activity of ADXS11-001 for patients with persistent or recurrent carcinoma of the cervix with the frequency of patients who survive for at least 12 months after initiating therapy.

SECONDARY OBJECTIVES:

  1. To characterize the distribution of progression-free survival and overall survival.

II. To examine the proportion of patients with objective tumor response.

TERTIARY OBJECTIVES:

  1. To assess changes in clinical immunology based upon serum cytokines and to correlate any observed changes with clinical response including progression-free survival, overall survival, tumor response, DLTs, and adverse effects.

II. To examine associations between presence and type of high-risk human papillomavirus (H-HPV) and measures of clinical response and serum cytokine levels.

OUTLINE:

Patients receive live-attenuated Listeria monocytogenes cancer vaccine ADXS11-001 intravenously (IV) over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Being tested
Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001, Laboratory Biomarker Analysis
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001Biological

    Also called ADXS11-001, ADXS11-001 Vaccine, Attenuated Live Listeria Encoding HPV 16 E7 Vaccine, Attenuated Live Listeria Encoding Human Papilloma Virus 16 E7 Vaccine

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT01266460
Study groupRoleWhat they receive
Treatment (ADXS11-001)ExperimentalPatients receive live-attenuated Listeria monocytogenes cancer vaccine ADXS11-001 IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients With Dose-limiting Toxicities, as Assessed by CTCAE v 4.0

    Number of patients with dose-limiting toxicities, as assessed by CTCAE v 4.0

    Measured: 28 days

  2. Incidence of Adverse Effects as Assessed by CTCAE v 4.0

    Incidence of adverse effects as assessed by CTCAE v 4.0 (i.e. the number of patients experiencing at least one grade 3 adverse event)

    Measured: Adverse events were collected an average of 4 years 7 months

  3. Number of Patients Who Survive for at Least 12 Months

    The number of patients (and percentage) who survive for at least 12 months.

    Measured: 12 months

Secondary outcomes (3)

  1. Distribution of Overall Survival

    Characterized with Kaplan-Meier plots and estimates of the median time until death.

    Measured: Patients will be followed (physical exams and histories) every three months for the first three years, then every six months for the next two years. Patients will be monitored for delayed toxicity and survival for 5-year period, unless consent withdrawn.

  2. Distribution of Progression-free Survival

    Characterized with Kaplan-Meier plots and estimates of the median time until progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: Patients will be followed (physical exams and histories) every three months for the first three years, then every six months for the next two years. Patients will be monitored for delayed toxicity and survival for 5-year period, unless consent withdrawn.

  3. Number of Patients Who Have Objective Tumor Response (Complete or Partial)

    The number of patients who have objective tumor response (complete response or partial response). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: Patients will be followed (physical exams and histories) every three months for the first three years, then every six months for the next two years. Patients will be monitored for delayed toxicity and survival for 5-year period, unless consent withdrawn.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2010 (estimated)
  2. Study start23 May 2011
  3. Primary completion2 Oct 2018
  4. Study completion2 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01266460
Sponsor's protocol ID
GOG-0265
Other IDs
NCI-2011-02671, GOG-0265, CDR0000691288, GOG-0265, GOG-0265, U10CA180830, U10CA180868, U10CA027469
Status last verified
Aug 2020
First submitted
23 Dec 2010
Last updated
11 Sep 2020
Data monitoring committee
Yes

Publications

  • Huh WK, Brady WE, Fracasso PM, Dizon DS, Powell MA, Monk BJ, Leath CA 3rd, Landrum LM, Tanner EJ, Crane EK, Ueda S, McHale MT, Aghajanian C. Phase II study of axalimogene filolisbac (ADXS-HPV) for platinum-refractory cervical carcinoma: An NRG oncology/gynecologic oncology group study. Gynecol Oncol. 2020 Sep;158(3):562-569. doi: 10.1016/j.ygyno.2020.06.493. Epub 2020 Jul 6.

    PubMed 32641240

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001 and Laboratory Biomarker Analysis in people with Cervical Adenocarcinoma and Cervical Adenosquamous Carcinoma, run by Gynecologic Oncology Group at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 35 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Dose-limiting Toxicities, as Assessed by CTCAE v 4.0 (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01266460, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in