Safety Study to Test the Safety of HspE7 and Poly-ICLC Given in Patients With Cervical Intraepithelial Neoplasia
A Multicenter, Nonrandomized, Open-Label Phase 1 Safety Study of HspE7 and Poly-ICLC Administered Concomitantly in Cervical Intraepithelial Neoplasia (CIN) Subjects
1 other identifier
interventional
24
1 country
8
Brief Summary
The purpose of this study is to determine the safety and tolerability of HspE7 and Poly-ICLC when given together
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2007
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 26, 2007
CompletedFirst Posted
Study publicly available on registry
June 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedMay 7, 2008
May 1, 2008
1.1 years
June 26, 2007
May 5, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of HspE7 and Poly-ICLC administered concomitantly for Cervical Intraepithelial Neoplasia
4 Weeks after the last of 3 Injections
Secondary Outcomes (1)
Tolerability of HspE7 and Poly-ICLC administered concomitantly for Cervical Intraepithelial Neoplasia
4 Weeks after the last of 3 Injections
Interventions
3 injections of HspE7 and Poly ICLC given every 28 days for 3 injections
Eligibility Criteria
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 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.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
University of Southern California
Los Angeles, California, 90033, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Medical College of Georgia
Augusta, Georgia, 30912, United States
Montefiore Medical Center
New York, New York, 10461, United States
University of Oklahoma Health Sciences Center (OUHSC) / OU Medical Center
Oklahoma City, Oklahoma, 73104, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Mt Timpanagos Women's Health Center
Pleasant Grove, Utah, 84062, United States
Salt Lake Women's Center
South Salt Lake, Utah, 84070, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 26, 2007
First Posted
June 28, 2007
Study Start
May 1, 2007
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
May 7, 2008
Record last verified: 2008-05