Vaccine Therapy in Treating Patients With Persistent or Recurrent Cervical Cancer

NCT01266460 | Completed Phase 2 Results DMC

• 6 other identifiers: GOG-0265NCI-2011-02671CDR0000691288U10CA180830U10CA180868U10CA027469
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 24

Brief 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.

Conditions

Cervical Adenocarcinoma; Cervical Adenosquamous Carcinoma; Cervical Squamous Cell Carcinoma, Not Otherwise Specified; Recurrent Cervical Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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

  28 days

• 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)

  Adverse events were collected an average of 4 years 7 months

• Number of Patients Who Survive for at Least 12 Months

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

  12 months

Secondary Outcomes (3)

• Distribution of Overall Survival

  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 Patients will be monitored for delayed toxicity and survival for 5-year period, unless consent withdrawn.

• Distribution of Progression-free Survival

  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 Patients will be monitored for delayed toxicity and survival for 5-year period, unless consent withdrawn.

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

  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 Patients will be monitored for delayed toxicity and survival for 5-year period, unless consent withdrawn.

Other Outcomes (1)

• Changes in Clinical Immunology Based Upon Serum

  Baseline to up to 24 hours after dose 3

Study Arms (1)

Treatment (ADXS11-001)

EXPERIMENTAL

Patients 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.

Biological: Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001; Other: Laboratory Biomarker Analysis

Interventions

Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001 BIOLOGICAL

Given IV

Also known as: ADXS11-001, ADXS11-001 Vaccine, Attenuated Live Listeria Encoding HPV 16 E7 Vaccine, Attenuated Live Listeria Encoding Human Papilloma Virus 16 E7 Vaccine, Lm-LLO-E7, Lovaxin-C

Treatment (ADXS11-001)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (ADXS11-001)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• Advaxis, Inc.: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (24)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

Location

Saint Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

UCSF Medical Center-Mount Zion

San Francisco, California, 94115, United States

Location

UCSF Medical Center-Mission Bay

San Francisco, California, 94158, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Montefiore Medical Center-Einstein Campus

The Bronx, New York, 10461, United States

Location

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, 44060, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Oklahoma Cancer Specialists and Research Institute-Tulsa

Tulsa, Oklahoma, 74146, United States

Location

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0565, United States

Location

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

Froedtert and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• 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.

  PMID: 32641240 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Christopher Purdy on behalf of Austin Miller PhD
• Organization: NRG Oncology

purdyc@nrgoncology.org

(716) 845-1300

Study Officials

• Warner K Huh

  NRG Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2010
• First Posted: December 24, 2010
• Study Start: May 23, 2011
• Primary Completion: October 2, 2018
• Study Completion: October 2, 2018
• Last Updated: September 11, 2020
• Results First Posted: September 11, 2020

Record last verified: 2020-08

Locations

US (24)