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

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:

A Multicenter, Nonrandomized, Open-Label Phase 1 Safety Study of HspE7 and Poly-ICLC Administered Concomitantly in Cervical Intraepithelial Neoplasia (CIN) Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00493545
• Other study ID #: HspE7-00101-0601
• Status: Active, not recruiting
• Phase: Phase 1
• First received: June 26, 2007
• Last updated: May 5, 2008
• Start date: May 2007
• Est. completion date: June 2008

Study information

• Verified date: May 2008
• Source: Nventa Biopharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Neoplasms

Intervention

Biological:
• HspE7 and Poly-ICLC
3 injections of HspE7 and Poly ICLC given every 28 days for 3 injections

Locations

Country	Name	City	State
United States	Medical College of Georgia	Augusta	Georgia
United States	Baylor College of Medicine	Houston	Texas
United States	University of Southern California	Los Angeles	California
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	Mt Timpanagos Women's Health Center	Pleasant Grove	Utah
United States	Salt Lake Women's Center	S. Salt Lake	Utah
United States	Medical Center for Clinical Research	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Nventa Biopharmaceuticals Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of HspE7 and Poly-ICLC administered concomitantly for Cervical Intraepithelial Neoplasia		4 Weeks after the last of 3 Injections	No
Secondary	Tolerability of HspE7 and Poly-ICLC administered concomitantly for Cervical Intraepithelial Neoplasia		4 Weeks after the last of 3 Injections	No