Phase 2
N=50
Vaccine Therapy in Treating Patients With Persistent or Recurrent Cervical Cancer
Cervical Adenocarcinoma · Cervical Adenosquamous Carcinoma · Cervical Squamous Cell Carcinoma, Not Otherwise Specified · Recurrent Cervical Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01266460 ↗Enrolled (actual)
50
Serious AEs
54.0%
Results posted
Sep 2020
Primary outcome: Primary: Number of Patients With Dose-limiting Toxicities, as Assessed by CTCAE v 4.0 — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001 (Biological); Laboratory Biomarker Analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Gynecologic Oncology Group
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Dose-limiting Toxicities, as Assessed by CTCAE v 4.0 |
— | — |
| PRIMARY Incidence of Adverse Effects as Assessed by CTCAE v 4.0 |
29 | — |
| PRIMARY Number of Patients Who Survive for at Least 12 Months |
19 | — |
| SECONDARY Distribution of Overall Survival |
6.1 | — |
| SECONDARY Distribution of Progression-free Survival |
2.8 | — |
| SECONDARY Number of Patients Who Have Objective Tumor Response (Complete or Partial) |
0; 2; 5; 32; 11 | — |
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.
Eligibility 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 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 alani
Data sourced from ClinicalTrials.gov (NCT01266460). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.