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

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

Study Overview

• Status: Unknown
• Conditions: Cervical Intraepithelial Neoplasia
• Intervention / Treatment: Biological: HspE7 and Poly-ICLC

Detailed Description

Approximately 600 million people worldwide are infected with the Human Papilloma Virus. In the majority of cases people can clear the virus on their own however in cases where the infection is not recognized or is left untreated, the result can be cervical cancer.

This study will examine the safety and tolerability of Hsp-E7 and Poly-ICLC administered together as a vaccine for Cervical Intraepithelial neoplasia (CIN). There will be 4 cohorts of subjects in the study each given a higher dose than the one prior providing that prior dose has been well tolerated and deemed to be safe.

Subjects will be immunized every 28 days for a period of 8 weeks (3 administrations).

Posttreatment evaluation will occur 4 weeks after the last of 3 injections. Subjects with CIN 2 or 3 disease at the time of enrollment will be eligible to undergo clinically appropriate therapeutic treatment of the cervix at the twelfth of the study.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • San Diego, California, United States, 92108
      • Medical Center for Clinical Research
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Medical College of Georgia
  • New York
    • New York, New York, United States, 10461
      • Montefiore Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center (OUHSC) / OU Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
  • Utah
    • Pleasant Grove, Utah, United States, 84062
      • Mt Timpanagos Women's Health Center
    • S. Salt Lake, Utah, United States, 84070
      • Salt Lake Women's Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Histologically documented Cervical Intraepithelial Neoplasia 1, 2 or 3.
2. 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).
3. Geographically accessible for ongoing follow up and committed to comply with all visits.
4. Judged to be in good health based upon the results of a medical history, physical examination, vital signs and laboratory profile.
5. Capable of understanding and complying with the protocol and has signed the informed consent.
6. Negative for human immunodeficiency virus (HIV)-1, HIV-2, Hepatitis B surface antigen, and hepatitis C Virus.

Exclusion Criteria:

Prior to Therapy:

1. Prior exposure to HspE7.
2. 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.
3. Taken within 7 days or is currently taking selective Cox-2 inhibitors and other nonsteroidal anti-inflammatory drugs.
4. Received investigational systemic drugs within 4 weeks (28 days) prior to study entry.
5. Undergoing active treatment of genital warts.
6. Has taken astemizole within 7 days prior to study drug administration.

Disease Status:

1. 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.
2. Has a recognized immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia. The subject has hereditary or congenital immunodeficiencies.
3. Has a positive endocervical curettage at the time of biopsy.

Physiological Functions:

1. Has clinically significant hepatic dysfunction (ie, alanine aminotransferase, aspartate aminotransferase, or total bilirubin ≥1.5 x upper limit of normal (ULN).
2. Has clinically significant renal dysfunction (ie, serum creatinine ≥1.5 x ULN).
3. 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.
4. Has had a splenectomy.
5. Has an infectious process that in the opinion of the investigator would compromise the subject's ability to mount an immune response.
6. 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.
7. Has donated or lost a significant volume of blood or plasma (greater than 450 mL) within 30 days of the study.

Standard Safety:

1. 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.
2. Any other reason that, in the opinion of the investigator, precludes the subject from participating in the study.
3. Known hypersensitivity reaction to any of the components of study treatments.
4. Known alcohol or drug abuse, as assessed by the investigator.
5. Legal incapacity or limited legal capacity.

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety of HspE7 and Poly-ICLC administered concomitantly for Cervical Intraepithelial Neoplasia	4 Weeks after the last of 3 Injections

Secondary Outcome Measures

Outcome Measure	Time Frame
Tolerability of HspE7 and Poly-ICLC administered concomitantly for Cervical Intraepithelial Neoplasia	4 Weeks after the last of 3 Injections

Collaborators and Investigators

• Sponsor: Nventa Biopharmaceuticals Corporation

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Anticipated): June 1, 2008
• Study Completion (Anticipated): June 1, 2008

Study Registration Dates

• First Submitted: June 26, 2007
• First Submitted That Met QC Criteria: June 26, 2007
• First Posted (Estimate): June 28, 2007

Study Record Updates

• Last Update Posted (Estimate): May 7, 2008
• Last Update Submitted That Met QC Criteria: May 5, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: Safety; Multicenter; Open-Label; Nonrandomized
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms; Carcinoma in Situ; Cervical Intraepithelial Neoplasia; Physiological Effects of Drugs; Immunologic Factors; Interferon Inducers; Poly ICLC
• Other Study ID Numbers: HspE7-00101-0601