Brief Title
Safety Study to Test the Safety of HspE7 and Poly-ICLC Given in Patients With Cervical Intraepithelial Neoplasia
Official Title
A Multicenter, Nonrandomized, Open-Label Phase 1 Safety Study of HspE7 and Poly-ICLC Administered Concomitantly in Cervical Intraepithelial Neoplasia (CIN) Subjects
Brief Summary
The purpose of this study is to determine the safety and tolerability of HspE7 and Poly-ICLC
when given together
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 Phase
Phase 1
Study Type
Interventional
Primary Outcome
Safety of HspE7 and Poly-ICLC administered concomitantly for Cervical Intraepithelial Neoplasia
Secondary Outcome
Tolerability of HspE7 and Poly-ICLC administered concomitantly for Cervical Intraepithelial Neoplasia
Condition
Cervical Intraepithelial Neoplasia
Intervention
HspE7 and Poly-ICLC
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
24
Start Date
May 2007
Completion Date
June 2008
Primary Completion Date
June 2008
Eligibility Criteria
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00493545
Organization ID
HspE7-00101-0601
Study Sponsor
Nventa Biopharmaceuticals Corporation
Study Sponsor
, ,
Verification Date
May 2008