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Cervical Intraepithelial NeoplasiaPhase 2TG-003NCT00596258

A Two-Stage Phase 2 Study Of A-007 Topical Gel in High-Grade Squamous Intraepithelial Lesions (HSIL)

A Phase 2 study testing A-007 in people with Cervical Intraepithelial Neoplasia and Uterine Cervical Dysplasia, run by Tigris Pharmaceuticals at 5 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

A-007 is an investigational therapy which may be effective in the treatment of pre-cancerous cervical dysplasia (abnormal cell growth). The purpose of this study is to evaluate the safety and efficacy of A-007, when used to treat high-grade cervical dysplasia. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
A-007
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
5 sitesUnited States
Study dates
Nov 2007to Aug 2008
Phase
Phase 2
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

  • 18 years of age or older
  • The patient or her authorized representative must sign and date an Ethical Review Board-approved informed consent document. All aspects of the protocol must be explained and written informed consent obtained.
  • Patients must have histologic proof of CIN 2/3 disease documented within the last 12 weeks. If patient is enrolled using prior local biopsy, local slides and pathology report must be sent to the central laboratory. Patient may be enrolled into the study based on local laboratory results of CIN 2/3 and will not be discontinued if central laboratory results differ.
  • Cervical swabs must test positive for high risk HPV (by Hybrid Capture 2). If the patient tests negative for high risk HPV and has proof of CIN 2/3, the patient should be retested one additional time for high-risk HPV.
  • Patients must have a Hgb ≥ 9 g/dl, a peripheral WBC ≥ 3000 mm3 and platelet counts ≥100,000 mm3.
  • Normal hepatic and renal functions - AST and ALT <2.5 x ULN and creatinine <1.5 x ULN, respectively.
  • Females of childbearing potential must use one of the following birth control methods during the study (until performance of the LEEP at month 4): oral, implantable, injectable contraceptives; abstinence (celibacy). Contraceptive sponges, IUD, vaginal contraceptive rings, spermacides, sponges, condoms, or partner's vasectomy are not acceptable methods of birth control.

Who cannot join

  • Patients with CIN 1 or with invasive squamous cell carcinoma (SCC).
  • CIN appearing to involve the endocervix, as assessed colposcopically
  • CIN not amenable to adequate colposcopic follow-up evaluations, i.e. unsatisfactory colposcopy.
  • CIN 3 involving more than two cervical quadrants on colposcopy.
  • Patients treated for cervical SIL within the past year.
  • Patients who have had a LEEP performed in the past 12 months
Show all 17Show fewer
  • Patients with other malignancy (except non-melanoma skin) within the past 5 years.
  • Patients with any chronic, active infections (including HIV) other than HPV.
  • Patients with known clinically relevant immunological deficiency.
  • Concurrent treatment with cytotoxic, radiation, or immuno-stimulative therapy, or with systemic corticosteroids at a dose >5 mg/d of prednisone (or its equivalent).
  • Participation in another investigational medication trial concurrently or within 30 days, or prior administration of a prophylactic HPV vaccine or participation in an HPV vaccine trial. Treatment within the last 30 days with a medication that has not received regulatory approval at the time of study entry.
  • Concomitant use of topical vaginal medications.
  • Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.
  • History of allergy or hypersensitivity to cosmetics, toiletries, or other topical or dermatologic products.
  • Pregnant or lactating females who are nursing and will not consent to cease nursing.
  • Investigators, site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
  • Patients with known menstrual irregularity that is not resolved with cycling on hormonal contraception.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Visions Clinical Research

    Boynton Beach, Florida, 33437

  • Robin Black OGNP

    Costa Mesa, California, 92629

  • NYU School of Medicine

    New York, New York, 10016

  • Montefiore Medical Center-Weiler Division Dept of OB/GYN & Women's Health

    The Bronx, New York, 10461

  • Visions Clinical Research-Tucson

    Tucson, Arizona, 85712

Other trials in United States

About this study

Official title: A Two-Stage Phase 2 Study Of Dose-Intense 4,4'-Dihydroxybenzophenone-2,4-Dinitrophenyl-Hydrazone (A-007) Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix

A-007 is an investigational therapy which may be effective in the treatment of pre-cancerous cervical dysplasia (abnormal cell growth). The purpose of this study is to evaluate the safety and efficacy of A-007, when used to treat high-grade cervical dysplasia.

Read the detailed description

This is a non-randomized, two-stage phase II study with pathological response rate as the primary objective. Following biopsy confirmation of CIN 2/3 within the last 12 weeks, women will treat themselves with gel applied to the cervix via an intravaginal applicator. Patients will apply gel once daily for 14 consecutive days of a 28-day cycle for 2 cycles.

Women will return to clinic for safety assessments, colposcopy, cytology, and virologic and immunologic testing (see schedule of events in attachment TG-003.01 for visit intervals).

Following the two cycles of treatment with A-007, treating physicians will perform a LEEP at the month 4 visit. The investigator is responsible for ensuring that the LEEP is conducted according to the procedures and guidelines of their institution.

Being tested
A-007
Keywords
Cervical Intraepithelial Neoplasia (CIN), High-grade Cervical Intraepithelial Neoplasia, High-grade Squamous Intraepithelial Lesions (HSIL), Human Papilloma Virus (HPV), High-Grade Cervical Intraepithelial Lesions (CIN 2/3)
Medical subject headings
Uterine Cervical Dysplasia, Squamous Intraepithelial Lesions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A-007Drug

    applied topically for two 28-day cycles of 14 consecutive days of treatment each to the uterine cervix

Study groups in NCT00596258
Study groupRoleWhat they receive
A-007ExperimentalSingle arm open label
Receives: Drug: A-007

What is being measured

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

  1. Determine overall pathological response (complete and partial, based on independent review at month 4) of A-007 when applied topically for two 28-day cycles of 14 consec. days of treatment each to the uterine cervix of women with HSIL [CIN 2/3].

    Measured: Over the course of the trial

Secondary outcomes (2)

  1. Determine the local tolerability and systemic safety of A-007.

    Measured: over the course of the trial

  2. Evaluate the effects of A-007 gel treatment on human papillomavirus (HPV) eradication.

    Measured: over the course of the trial

Timeline

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

  1. First posted16 Jan 2008 (estimated)
  2. Study startNov 2007
  3. Primary completionJul 2008
  4. Study completionAug 2008

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00596258
Sponsor's protocol ID
TG-003
Acronym
TG-003
Status last verified
May 2009
First submitted
4 Jan 2008
Last updated
22 May 2009
Results posted
No
Data monitoring committee
No

Publications

  • Morgan LR, Thangaraj K, LeBlanc B, Rodgers A, Wolford LT, Hooper CL, Fan D, Jursic BS. Design, synthesis, and anticancer properties of 4,4'-dihydroxybenzophenone-2,4-dinitrophenylhydrazone and analogues. J Med Chem. 2003 Oct 9;46(21):4552-63. doi: 10.1021/jm0301080.

    PubMed 14521417

  • Morgan, LR, Hooper, CL, Rodgers, AH, LoRusso, P, Eilender, DE and Culotta, VA. 4,4'-Dihydroxybenzophenone-2,4-dinitrophenyl-hydrazone (A-007): A CD4+ T-Lymphocyte Modulator Useful in the Treatment of Advanced Cancer. Chemotherapy - accepted 2005.

  • Morgan, LR, Hooper, CL, Rodgers, AH Culotta, V et al. 4,4'-Dihydroxy benzophenone -2,4-dinitrophenylhydrazone (A-007) A Modulator of CD45+ T Lymphocytes in HPV Infected Anogenital Epithelium. In: HPV Vaccines and Immune Therapy, Cambridge, United Kingdom, 2003

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing A-007 in people with Cervical Intraepithelial Neoplasia and Uterine Cervical Dysplasia, run by Tigris Pharmaceuticals at 5 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 7 inclusion and 17 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 22 May 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Determine overall pathological response (complete and partial, based on independent review at month 4) of A-007 when applied topically for two 28-day cycles of 14 consec. days of treatment each to the uterine cervix of women with HSIL [CIN 2/3]. (time frame: Over the course of the trial). 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 NCT00596258, which also lists 3 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 22 May 2009.

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