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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Nventa Biopharmaceuticals Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Nventa Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT00493545
First received: June 26, 2007
Last updated: May 5, 2008
Last verified: May 2008
  Purpose

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


Condition Intervention Phase
Cervical Intraepithelial Neoplasia
Biological: HspE7 and Poly-ICLC
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Multicenter, Nonrandomized, Open-Label Phase 1 Safety Study of HspE7 and Poly-ICLC Administered Concomitantly in Cervical Intraepithelial Neoplasia (CIN) Subjects

Resource links provided by NLM:


Further study details as provided by Nventa Biopharmaceuticals Corporation:

Primary Outcome Measures:
  • Safety of HspE7 and Poly-ICLC administered concomitantly for Cervical Intraepithelial Neoplasia [ Time Frame: 4 Weeks after the last of 3 Injections ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability of HspE7 and Poly-ICLC administered concomitantly for Cervical Intraepithelial Neoplasia [ Time Frame: 4 Weeks after the last of 3 Injections ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: May 2007
Estimated Study Completion Date: June 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: HspE7 and Poly-ICLC
    3 injections of HspE7 and Poly ICLC given every 28 days for 3 injections
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493545

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

No publications provided

Responsible Party: Dr. Peter Emtage Vice President of Research and Development, Nventa Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT00493545     History of Changes
Other Study ID Numbers: HspE7-00101-0601
Study First Received: June 26, 2007
Last Updated: May 5, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Nventa Biopharmaceuticals Corporation:
Multicenter
Open-Label
Nonrandomized
Safety

Additional relevant MeSH terms:
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Neoplasms
Carcinoma
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Poly ICLC
Immunologic Factors
Interferon Inducers
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014