Spots Global Cancer Trial Database for Vaccine Therapy in Treating Patients With Persistent or Recurrent Cervical Cancer
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Trial Identification
Brief Title: Vaccine Therapy in Treating Patients With Persistent or Recurrent Cervical Cancer
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
Study ID: NCT01266460
Study Description
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.
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
Saint Joseph's Hospital and Medical Center, Phoenix, Arizona, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
Los Angeles County-USC Medical Center, Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
UCSF Medical Center-Mount Zion, San Francisco, California, United States
UCSF Medical Center-Mission Bay, San Francisco, California, United States
Memorial Health University Medical Center, Savannah, Georgia, United States
University of Kansas Cancer Center, Kansas City, Kansas, United States
Sinai Hospital of Baltimore, Baltimore, Maryland, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Montefiore Medical Center-Einstein Campus, Bronx, New York, United States
Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States
Case Western Reserve University, Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa, Oklahoma, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
University of Texas Medical Branch, Galveston, Texas, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Warner K Huh
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR
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