Vaccine Therapy in Treating Patients With Persistent or Recurrent Cervical Cancer

This study is currently recruiting participants.
Verified March 2014 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: March 7, 2014
Last verified: March 2014

December 23, 2010
March 7, 2014
May 2011
October 2018   (final data collection date for primary outcome measure)
  • Number of patients with dose-limiting toxicities, as assessed by CTCAE v 4.0 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Frequency and severity of adverse effects as assessed by CTCAE v 4.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Proportion of patients who survive for at least 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of patients with dose-limiting toxicities [ Designated as safety issue: Yes ]
  • Frequency and severity of adverse effects as assessed by CTCAE v 4.0 [ Designated as safety issue: Yes ]
  • Proportion of patients who survive for at least 12 months [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01266460 on ClinicalTrials.gov Archive Site
  • Distribution of overall survival [ Time Frame: 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: 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 ]
  • Distribution of overall survival [ Designated as safety issue: No ]
  • Distribution of progression-free survival [ Designated as safety issue: No ]
  • Proportion of patients who have objective tumor response (complete or partial) [ Designated as safety issue: No ]
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.
Not Provided
 
Vaccine Therapy in Treating Patients With Persistent or Recurrent Cervical Cancer
A Phase II Evaluation of ADXS11-001 (NSC 752718, BB-IND#13,712) 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 persistent or recurrent cervical cancer. Vaccines may help the body build an effective immune response to kill tumor cells.

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. Treatment repeats every 28 days for 3 courses 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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cervical Adenocarcinoma
  • Cervical Adenosquamous Cell Carcinoma
  • Cervical Small Cell Carcinoma
  • Cervical Squamous Cell Carcinoma
  • Recurrent Cervical Cancer
  • Stage III Cervical Cancer
  • Stage IVA Cervical Cancer
  • Stage IVB Cervical Cancer
  • Biological: live-attenuated Listeria monocytogenes cancer vaccine ADXS11-001
    Given IV
    Other Names:
    • ADXS11-001
    • attenuated live Listeria encoding HPV 16 E7 vaccine ADXS11-001
    • Lm-LLO-E7
    • Lovaxin C
  • Other: laboratory biomarker analysis
    Correlative studies
Experimental: Treatment (ADXS11-001)
Patients receive live-attenuated Listeria monocytogenes cancer vaccine ADXS11-001 IV over 30 minutes on day 1. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Interventions:
  • Biological: live-attenuated Listeria monocytogenes cancer vaccine ADXS11-001
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
67
Not Provided
October 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have persistent or recurrent squamous cell 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 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 or localized cancer of the breast, head and neck, or skin, 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 ciprofloxacin (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
  • No patients with uncontrolled intercurrent illness including, but not limited to:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • 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
Female
18 Years and older
No
Not Provided
United States
 
NCT01266460
GOG-0265, NCI-2011-02671, CDR0000691288, GOG-0265, GOG-0265, U10CA027469
Not Provided
Gynecologic Oncology Group
Gynecologic Oncology Group
  • National Cancer Institute (NCI)
  • Advaxis, Inc.
Principal Investigator: Warner Huh Gynecologic Oncology Group
Gynecologic Oncology Group
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP