Trial record 1 of 1 for:    GOG-0265
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Vaccine Therapy in Treating Patients With Persistent or Recurrent Cervical Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Gynecologic Oncology Group
Sponsor:
Collaborators:
Advaxis, Inc.
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01266460
First received: December 23, 2010
Last updated: July 28, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention Phase
Cervical Adenocarcinoma
Cervical Adenosquamous Carcinoma
Cervical Squamous Cell Carcinoma
Recurrent Cervical Carcinoma
Biological: Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001
Other: Laboratory Biomarker Analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Incidence of adverse effects as assessed by CTCAE v 4.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Number of patients with dose-limiting toxicities, as assessed by CTCAE v 4.0 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Proportion of patients who survive for at least 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Distribution of overall survival [ Time Frame: Time from study entry to time of death or the date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]
    Characterized with Kaplan-Meier plots and estimates of the median time until death.

  • Distribution of progression-free survival [ Time Frame: Time from study entry to time of progression or death, whichever occurs first, assessed up to 5 years ] [ Designated as safety issue: No ]
    Characterized with Kaplan-Meier plots and estimates of the median time until progression.

  • Proportion of patients who have objective tumor response (complete or partial) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Changes in clinical immunology based upon serum [ Time Frame: Baseline to up to 24 hours after dose 3 ] [ Designated as safety issue: No ]
    Examined with descriptive statistics and graphics, and their relationship with survival and tumor response will be examined with proportional hazards and logistic regression models, as appropriate.


Estimated Enrollment: 67
Study Start Date: May 2011
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (ADXS11-001)
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
Given IV
Other Names:
  • ADXS11-001
  • Attenuated Live Listeria Encoding HPV 16 E7 Vaccine
  • Attenuated Live Listeria Encoding Human Papilloma Virus 16 E7 Vaccine
  • Lm-LLO-E7
  • Lovaxin-C
Other: Laboratory Biomarker Analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. 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:

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

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

TERTIARY OBJECTIVES:

I. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 100,000/mcL
  • Absolute neutrophil count (ANC) count greater than or equal to 1,500/mcL
  • Lymphocyte count greater than or equal to 700/mcL
  • Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN)
  • Bilirubin less than or equal to 1.5 x ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 1.5 x ULN
  • Gamma-glutamyl transpeptidase (GGT) less than or equal to 1.5 x ULN
  • Alkaline phosphatase less than or equal to 2.5 x ULN
  • 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 be practicing an effective form of contraception during protocol therapy and for at least two months following completion of protocol therapy
  • Patients cannot be lactating
  • Patients must be able to swallow pills

Exclusion Criteria:

  • 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 allergic to both penicillin and trimethoprim/sulfamethoxazole (including history of rash or anaphylaxis)
  • Patients allergic to naproxen
  • Patients currently receiving antibiotics
  • Patients who have received within the past four weeks, or who are currently receiving, corticosteroids

    • Topical corticosteroids and occasional inhaled corticosteroids are allowed
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01266460

  Show 24 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Advaxis, Inc.
Investigators
Principal Investigator: Warner Huh NRG Oncology
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01266460     History of Changes
Other Study ID Numbers: GOG-0265, NCI-2011-02671, CDR0000691288, GOG-0265, GOG-0265, U10CA180868, U10CA027469
Study First Received: December 23, 2010
Last Updated: July 28, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Carcinoma, Adenosquamous
Carcinoma, Squamous Cell
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Complex and Mixed
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on July 30, 2015