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Uterine Cervical DysplasiaPhase 2/3NCT00264732

A Study of Amolimogene (ZYC101a) in Patients With High Grade Cervical Intraepithelial Lesions of the Uterine Cervix

A Phase 2/3 study testing Amolimogene in people with Uterine Cervical Dysplasia, run by Eisai Inc. at 26 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of amolimogene, in the treatment of patients with high-grade cervical intraepithelial lesions of the uterine cervix. Read more about this study

Who is it for?
Ages 13 to 25 years, women only
Conditions the study is for
Uterine Cervical Dysplasia
What is being tested?
Amolimogene
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
251 participants
Where
26 sitesUnited States
Study dates
Jul 2005to May 2009
Phase
Phase 2/3
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 13 to 25 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • To be considered for enrollment, patients must:
  • Have an abnormal Pap smear (atypical squamous cells of undetermined significance [ASCUS], atypical squamous cells, cannot exclude high grade [ASC-H], low grade squamous intraepithelial lesion [LSIL], high grade squamous intraepithelial lesion [HSIL]) result within 6 months of screening visit.
  • Have a colposcopically visible lesion suspected to be high-grade that does not involve more than 75% of the cervix.
  • Have a CIN 2/3 consensus pathology diagnosis on tissue taken from a colposcopically-directed punch biopsy.
  • Not have evidence of cervical carcinoma on Pap smear or biopsy and not have a positive endocervical curettage.
  • Not have atypical endometrial cells or glandular-cell atypia on Pap smear or biopsy.
Show all 24Show fewer
  • Have colposcopic visualization of entire squamocolumnar junction and of the entire lesion (i.e. cannot extend into canal).
  • Not have concomitant cancer, history of malignancies, including carcinoma of the cervix, except for non-melanoma skin cancer.
  • Be willing to sign an Institutional Review Board (IRB) approved informed consent. Minors must have the consent of a parent or legal guardian as required by local laws and regulations.
  • Agree to use 2 acceptable forms of contraception (e.g., double-method including at least one barrier and one hormonal method).
  • Be capable of complying with the protocol.
  • Not have other illnesses that would put the patient at undue risk for participation in the trial or would interfere with the required clinical observations.
  • Not have abnormalities of hematological, renal, or hepatic function as determined by clinical laboratory testing.
  • Not have immunologic disorder such as immunodeficiency, lupus, or other chronic auto-immune disease.
  • Not have an active systemic infection requiring treatment.
  • Not have ongoing systemic chronic steroid therapy or immunosuppressive medication (inhalers used for treating asthma and topical steroids are permitted).
  • Not be positive for HIV antibody.
  • Not be pregnant or lactating.
  • Not plan to use a cervical cap or diaphragm during the study.
  • Not have been treated with any investigational agent within 30 days prior to randomization in this trial.
  • Not have had prior gene therapy.
  • Not have had an excisional or ablative procedure performed on the cervix within one year of enrollment.
  • Be willing to consent to an excisional procedure, such as LEEP or cold-knife cone procedure, if indicated.
  • Please note: There may be additional inclusion/exclusion criteria. The study center will determine if patients meet all of the criteria. If patients do not qualify for the trial, study personnel will explain the reasons. If patients do qualify, study personnel will explain the trial in detail using an IRB-approved informed consent, and answer any questions. Patients can then decide if they wish to participate.

Who cannot join

None listed.

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

United States26 sites

  • Southwest Clinical Research

    Albuquerque, New Mexico, 87102

  • Medical College of Georgia, Department of Family Medicine

    Augusta, Georgia, 30912

  • University of Alabama

    Birmingham, Alabama, 35205

  • Visions Clinical Research

    Boynton Beach, Florida, 33472

  • Arrowhead Regional Medical Center

    Colton, California, 92324

  • UT Southwestern Medical Center at Dallas

    Dallas, Texas, 75390

  • Rosemark Women's Care Specialists

    Idaho Falls, Idaho, 83404

  • Physicians Research Options, LC

    Lakewood, Colorado, 80228

  • Sarah Cannon Research

    Memphis, Tennessee, 38120

  • University of Florida, Miami

    Miami, Florida, 33136

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Michael Altenbern, MD

    Nashville, Tennessee, 33437

  • Centennial Hills OB-GYN Associaties

    North Las Vegas, Nevada, 89030

  • The University of Oklahoma Health Sciences Center, Center for Research in Women's Health

    Oklahoma City, Oklahoma, 73104

  • The Center for Advanced Research and Education, Inc.

    Palm Springs, California, 92262

  • Temple Center for Women's Health

    Philadelphia, Pennsylvania, 19140

  • Arizona Wellness Center for Women/Precision Trials, LLC

    Phoenix, Arizona, 85032

  • Physicians' Research Options

    Pleasant Grove, Utah, 84062

  • Medical Center for Clinical Research

    San Diego, California, 92108

  • Physicians' Research Options, LLC

    Sandy City, Utah, 84070

  • Physician Care Clinical Research

    Sarasota, Florida, 34239

  • Insignia Clinical Research

    Tampa, Florida, 33613

  • University of Arizona

    Tucson, Arizona, 85724

  • Tidewater Clinical Research

    Virginia Beach, Virginia, 23456

  • Comprehensive Clinical Trials LLC

    West Palm Beach, Florida, 33409

  • Lyndhurst Gynecologic Associates

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of Amolimogene (ZYC101a) in the Treatment of High-Grade Cervical Intraepithelial Lesions (CIN 2/3) of the Uterine Cervix

The purpose of this study is to evaluate the efficacy and safety of amolimogene, in the treatment of patients with high-grade cervical intraepithelial lesions of the uterine cervix.

Read the detailed description

This is a double-blind study, so neither the patient not the doctor will know which treatment has been assigned.

Being tested
Amolimogene, Placebo
Keywords
cervical lesions, cervical dysplasia, Human papilloma virus, abnormal Pap, High-grade cervical intraepithelial lesions (CIN 2/3)
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.

  • AmolimogeneDrug

    Also called ZYC101a

    1-dose amolimogene Group: Two intramuscular (IM) injections (100 micrograms ZYC101a per injection), one in each quadriceps, at Treatment Initiation. Single IM placebo injections (approximately 1 mL 0.9% sterile saline) at Weeks 3 and 6 in alternating quadriceps.

  • AmolimogeneDrug

    Also called ZYC101a

    3-dose amolimogene Group: Two IM injections (100 micrograms ZYC101a per injection), one in each quadriceps, at Treatment Initiation. Single IM injections of 100 micrograms ZYC101a at Weeks 3 and 6 in alternating quadriceps.

  • PlaceboOther

    Placebo Group: Two IM placebo injections at Treatment Initiation (1 injection in each quadriceps). Single placebo injections at Weeks 3 and 6 in alternating quadriceps. Each placebo injection consists of approximately 1 mL 0.9% sterile saline.

Study groups in NCT00264732
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: Amolimogene
2ExperimentalNot described
Receives: Drug: Amolimogene
3Placebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cervical intraepithelial neoplasia (CIN) 2/3 resolution, defined as the histological evaluation of cervical tissue (presence or absence of CIN 2/3 as determined by pathology consensus diagnosis) at the End of Observation (EOO) period.

    Measured: 24 weeks after enrollment.

Secondary outcomes (5)

  1. Histology based on biopsy to determine the proportion of pts. w/resolution of CIN2/3. This is the same as primary efficacy variable in determination of presence or absence of CIN2/3, but excludes pts. with excisional procedure or cytology information.

    Measured: 24 weeks after enrollment.

  2. Histological resolution to normal to examine the proportion of patients with a histology result of "normal" versus "abnormal."

    Measured: 24 weeks after enrollment.

  3. Clearing or persistence of lesions based on colposcopic findings to examine the proportion of patients with "no lesion" versus "at least one lesion."

    Measured: 24 weeks after enrollment.

  4. Pap smear cytology.

    Measured: 24 weeks after enrollment.

  5. Clearing or persistence of original human papillomavirus (HPV) subtype as determined by HPV typing to present the number and percent of patients with absence of all HPV.

    Measured: 24 weeks after enrollment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2005 (estimated)
  2. Study startJul 2005
  3. Primary completionMay 2009
  4. Study completionMay 2009

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
251 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00264732
Sponsor's protocol ID
ZYC1-004
Status last verified
May 2012
First submitted
12 Dec 2005
Last updated
29 May 2013
Results posted
No

Publications

  • Crum CP, Beach KJ, Hedley ML, Yuan L, Lee KR, Wright TC, Urban RG. Dynamics of human papillomavirus infection between biopsy and excision of cervical intraepithelial neoplasia: results from the ZYC101a protocol. J Infect Dis. 2004 Apr 15;189(8):1348-54. doi: 10.1086/382956. Epub 2004 Mar 30.

    PubMed 15073670

  • Garcia F, Petry KU, Muderspach L, Gold MA, Braly P, Crum CP, Magill M, Silverman M, Urban RG, Hedley ML, Beach KJ. ZYC101a for treatment of high-grade cervical intraepithelial neoplasia: a randomized controlled trial. Obstet Gynecol. 2004 Feb;103(2):317-26. doi: 10.1097/01.AOG.0000110246.93627.17.

    PubMed 14754702

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Amolimogene in people with Uterine Cervical Dysplasia, run by Eisai Inc. at 26 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 24 inclusion and 0 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: finished, as of the sponsor's last update on 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Cervical intraepithelial neoplasia (CIN) 2/3 resolution, defined as the histological evaluation of cervical tissue (presence or absence of CIN 2/3 as determined by pathology consensus diagnosis) at the End of Observation (EOO) period. (time frame: 24 weeks after enrollment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00264732, which also lists 2 linked publications.

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 29 May 2013.

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