Cervical Adenocarcinoma Clinical Trial
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02562729 -
Complete Nerve-Sparing Radical Hysterectomy for Cervical Cancer
|
Phase 2 | |
| Completed |
NCT00416455 -
Fludeoxyglucose (FDG) F 18 PET Scan, CT Scan, and Ferumoxtran-10 MRI Scan Before Chemotherapy and Radiation Therapy in Finding Lymph Node Metastasis in Patients With Locally Advanced Cervical Cancer or High-Risk Endometrial Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT00054444 -
Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer
|
Phase 1 | |
| Recruiting |
NCT05210348 -
Clinical Evaluation of Detection of High Risk HPV in Urine
|
||
| Active, not recruiting |
NCT02140021 -
Biospecimen Collection and Testing for the Prevalence of Anal Dysplasia and Anal Cancer in Patients With Cervical, Vaginal and Vulvar Dysplasia and Cancer
|
N/A | |
| Completed |
NCT00068549 -
Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer
|
Phase 1 | |
| Completed |
NCT01711515 -
Chemoradiation Therapy and Ipilimumab in Treating Patients With Stages IB2-IIB or IIIB-IVA Cervical Cancer
|
Phase 1 | |
| Terminated |
NCT00924066 -
Ixabepilone to Treat Cervical Cancer
|
Phase 2 | |
| Completed |
NCT00559377 -
FDG and FMISO PET Hypoxia Evaluation in Cervical Cancer
|
Phase 2 | |
| Completed |
NCT00309959 -
ABI-007 in Treating Patients With Persistent or Recurrent Cervical Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT05613283 -
Primary Cervical Cancer Screening by Self-sampling HPV Test
|
||
| Recruiting |
NCT03742869 -
HPV Integration and Tumorigenesis of Uterine Cervical Adenocarcinoma
|
||
| Withdrawn |
NCT03834571 -
Testing the Addition of Paclitaxel and Carboplatin Given After Standard Chemotherapy and Radiation for Cervical Cancer in HIV-positive Women
|
Phase 2 | |
| Completed |
NCT00064077 -
Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix
|
Phase 3 | |
| Active, not recruiting |
NCT02257528 -
Nivolumab in Treating Patients With Persistent, Recurrent, or Metastatic Cervical Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT02466971 -
Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers
|
Phase 3 | |
| Completed |
NCT02164461 -
Axalimogene Filolisbac (ADXS11-001) High Dose in Women With Human Papillomavirus (HPV) + Cervical Cancer
|
Phase 1 | |
| Completed |
NCT01281852 -
Paclitaxel, Cisplatin, and Veliparib in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT04622670 -
Yoga Therapy During Chemotherapy and Radiation Treatment for the Improvement of Physical and Emotional Well-Being in Patients With Stage IB2-IIIB Cervical Cancer
|
N/A | |
| Completed |
NCT02921269 -
Atezolizumab and Bevacizumab in Treating Patients With Recurrent, Persistent, or Metastatic Cervical Cancer
|
Phase 2 |