Cervical Intraepithelial NeoplasiaPhase 1NCT00493545
Safety Study to Test the Safety of HspE7 and Poly-ICLC Given in Patients With Cervical Intraepithelial Neoplasia
A Phase 1 study testing HspE7 and Poly-ICLC in people with Cervical Intraepithelial Neoplasia, run by Nventa Biopharmaceuticals Corporation at 8 sites in United States.
Trial summary
The purpose of this study is to determine the safety and tolerability of HspE7 and Poly-ICLC when given together Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- What is being tested?
- HspE7 and Poly-ICLC
- Type of treatment
- Injection or infusion
- How many people
- 24 participants
- Where
- 8 sitesUnited States
- Study dates
- May 2007to Jun 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Has taken astemizole within 7 days prior to study drug administration.
- Disease Status:
- 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.
- 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.
- Has an infectious process that in the opinion of the investigator would compromise the subject's ability to mount an immune response.
- 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.
- Has donated or lost a significant volume of blood or plasma (greater than 450 mL) within 30 days of the study.
- Standard Safety:
- 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.
- Any other reason that, in the opinion of the investigator, precludes the subject from participating in the study.
- Known hypersensitivity reaction to any of the components of study treatments.
- Known alcohol or drug abuse, as assessed by the investigator.
- Legal incapacity or limited legal capacity.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Medical College of Georgia
Augusta, Georgia, 30912
Baylor College of Medicine
Houston, Texas, 77030
University of Southern California
Los Angeles, California, 90033
Montefiore Medical Center
New York, New York, 10461
University of Oklahoma Health Sciences Center (OUHSC) / OU Medical Center
Oklahoma City, Oklahoma, 73104
Mt Timpanagos Women's Health Center
Pleasant Grove, Utah, 84062
Medical Center for Clinical Research
San Diego, California, 92108
Salt Lake Women's Center
South Salt Lake, Utah, 84070
About this study
Official title: 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
Read the 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.
- Conditions
- Cervical Intraepithelial Neoplasia
- Being tested
- HspE7 and Poly-ICLC
- Keywords
- Multicenter, Open-Label, Nonrandomized, Safety
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HspE7 and Poly-ICLCBiological
3 injections of HspE7 and Poly ICLC given every 28 days for 3 injections
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of HspE7 and Poly-ICLC administered concomitantly for Cervical Intraepithelial Neoplasia
Measured: 4 Weeks after the last of 3 Injections
Secondary outcomes (1)
Tolerability of HspE7 and Poly-ICLC administered concomitantly for Cervical Intraepithelial Neoplasia
Measured: 4 Weeks after the last of 3 Injections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2007 (estimated)
- Study startMay 2007
- Primary completionJun 2008 (estimated)
- Study completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nventa Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493545
- Sponsor's protocol ID
- HspE7-00101-0601
- Status last verified
- May 2008
- First submitted
- 26 Jun 2007
- Last updated
- 7 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Nonrandomized, Open-Label Phase 1 Safety Study of HspE7 and Poly-ICLC Administered Concomitantly in Cervical Intraepithelial Neoplasia (CIN) Subjects
- ClinicalTrials.gov ID
- NCT00493545
- Acronym / sponsor ID
- HspE7-00101-0601
- Conditions
- Cervical Intraepithelial Neoplasia
- Keywords
- Multicenter, Open-Label, Nonrandomized, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Nventa Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Jun 2008 (estimated)
- Study completion
- Jun 2008 (estimated)
- First posted
- 28 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HspE7 and Poly-ICLC3 injections of HspE7 and Poly ICLC given every 28 days for 3 injections | Biological | – |
Primary outcome
Safety of HspE7 and Poly-ICLC administered concomitantly for Cervical Intraepithelial Neoplasia
Time frame: 4 Weeks after the last of 3 Injections
1 secondary outcome
Tolerability of HspE7 and Poly-ICLC administered concomitantly for Cervical Intraepithelial Neoplasia
Time frame: 4 Weeks after the last of 3 Injections
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HspE7 and Poly-ICLC in people with Cervical Intraepithelial Neoplasia, run by Nventa Biopharmaceuticals Corporation at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of HspE7 and Poly-ICLC administered concomitantly for Cervical Intraepithelial Neoplasia (time frame: 4 Weeks after the last of 3 Injections). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2008; AzTrials last refreshed its copy on 7 Nov 2026.