Safety Study to Test the Safety of HspE7 and Poly-ICLC Given in Patients With Cervical Intraepithelial Neoplasia

Status unconfirmed · Phase 1

Conditions studied: Cervical Intraepithelial Neoplasia

In brief

The purpose of this study is to determine the safety and tolerability of HspE7 and Poly-ICLC when given together

Key facts

Study ID: NCT00493545
Run by: Nventa Biopharmaceuticals Corporation
People needed: 24
Starts: 2007-05-01
Expected to finish: 2008-06-01
Last updated by the study team: 2008-05-07

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Histologically documented Cervical Intraepithelial Neoplasia 1, 2 or 3.
Nonpregnant, Nonlactating female greater than or equal to 18 years of age, who is either surgically sterile, postmenopausal (no menses for the previous 12 months), or practices an effective method of birth control (to be continued throughout the study period) as determined by the Investigator (eg: oral contraceptives, injectables or implants, intrauterine device, double-barrier methods). The use of cervical cap or diaphram is not permitted).
Geographically accessible for ongoing follow up and committed to comply with all visits.
Judged to be in good health based upon the results of a medical history, physical examination, vital signs and laboratory profile.
Capable of understanding and complying with the protocol and has signed the informed consent.
Negative for human immunodeficiency virus (HIV)-1, HIV-2, Hepatitis B surface antigen, and hepatitis C Virus.

You may not qualify if…

Prior to Therapy:
Prior exposure to HspE7.
The subject received immunotherapy (eg, interferons, tumor necrosis factor, interleukins, or biological response modifiers [GM CSF, G CSF, M CSF]) within 4 weeks (28 days) prior to study entry.
Taken within 7 days or is currently taking selective Cox-2 inhibitors and other nonsteroidal anti-inflammatory drugs.
Received investigational systemic drugs within 4 weeks (28 days) prior to study entry.
Undergoing active treatment of genital warts.
Has taken astemizole within 7 days prior to study drug administration.
Disease Status:
Has an autoimmune disease that in the opinion of the investigator would compromise the safety of the subject in this study. Some examples of autoimmune disease that may be considered exclusionary include rheumatoid arthritis, systematic lupus erythematosus, and autoimmune thyroiditis.
Has a recognized immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia. The subject has hereditary or congenital immunodeficiencies.
Has a positive endocervical curettage at the time of biopsy.
Physiological Functions:
Has clinically significant hepatic dysfunction (ie, alanine aminotransferase, aspartate aminotransferase, or total bilirubin ≥1.5 x upper limit of normal (ULN).
Has clinically significant renal dysfunction (ie, serum creatinine ≥1.5 x ULN).
Has clinically significant cardiac disease, eg, New York Heart Association classes III IV, uncontrolled angina, uncontrolled arrhythmia or uncontrolled hypertension, or myocardial infarction in the previous 6 months as confirmed by an electrocardiogram.
Has had a splenectomy.
Has an infectious process that in the opinion of the investigator would compromise the subject's ability to mount an immune response.
Has a history of severe allergic reaction to insect bites or stings, or to any biologic pharmaceutical product, including compounds similar to the test article.
Has donated or lost a significant volume of blood or plasma (greater than 450 mL) within 30 days of the study.
Standard Safety:
Is pregnant or breast-feeding, or a woman of childbearing potential unless using effective contraception as determined by the investigator. Subjects whom the investigator considers may be at risk of pregnancy will have a pregnancy test performed per institutional standard.
Any other reason that, in the opinion of the investigator, precludes the subject from participating in the study.
Known hypersensitivity reaction to any of the components of study treatments.
Known alcohol or drug abuse, as assessed by the investigator.
Legal incapacity or limited legal capacity.

Where it is running

University of Southern California — Los Angeles, California, United States
Medical Center for Clinical Research — San Diego, California, United States
Medical College of Georgia — Augusta, Georgia, United States
Montefiore Medical Center — New York, New York, United States
University of Oklahoma Health Sciences Center (OUHSC) / OU Medical Center — Oklahoma City, Oklahoma, United States
Baylor College of Medicine — Houston, Texas, United States
Mt Timpanagos Women's Health Center — Pleasant Grove, Utah, United States
Salt Lake Women's Center — South Salt Lake, Utah, United States

Full record on ClinicalTrials.gov

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