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A Phase II Single-arm Intervention Trial of Nelfinavir in Patients With Grade 2/3 or 3 Cervical Intraepithelial Neoplasia

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Joseph Anthony Lucci III, The University of Texas Health Science Center, Houston Identifier:
First received: April 30, 2013
Last updated: February 22, 2017
Last verified: February 2017
Preliminary data showed that Nelfinavir has selective apoptotic effects on HPV+ cervical tumor cell lines. Furthermore, in a Phase I clinical trial, the combination of NFV and chemoradiotherapy showed acceptable toxicity and promising activity in patients with pancreatic cancer. Therefore, for the proposed research, the principal investigator will use a single-arm Phase II intervention trial study design with focus on the efficacy of NFV to induce complete or partial remission of CIN 2/3 or CIN 3 as well as biomarker evaluation.

Condition Intervention Phase
Cervical Dysplasia
Drug: Nelfinavir
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • 1.1 Efficacy of Nelfinavir (NFV) to induce complete remission (or partial regression to CIN 1) of CIN 2/3 or CIN 3 as evaluated in the post-treatment excisional biopsy. [ Time Frame: 24 weeks ]


    Parameters of response:

    Histologic evaluation of the post-treatment LLETZ/cone specimen.

    (1) Persistent with worst disease being CIN 3; (2) Persistent with worst disease being CIN 2/3; (3) Persistent with worst disease being CIN 2; (4) Persistent with worst disease being CIN 1; (5) Normal tissue; no evidence of CIN present; (6) Squamous cell carcinoma, in situ.

    Histologic Complete Response will be judged as complete absence of any histologic evidence of CIN in the biopsy or LLETZ .

    Histologic Partial Response will be judged as regression of CIN 2/3 or CIN 3 to persistent disease with worst grade being CIN 1 in the LLETZ cone biopsy.

    Histologic Persistent Disease will be defined as evidence of CIN 2, CIN 2/3 or CIN 3 in the LLETZ/cone biopsy.

    Histologic Progression: Evidence of disease progression such as invasive carcinoma.

Secondary Outcome Measures:
  • targeted mechanism of NFV in histological response [ Time Frame: 24 weeks ]
    Pathway inhibition will be demonstrated when there is a decrease of PI3K and/or Akt on IHC between the enrollment biopsy and the final biopsy or the LLETZ/cone specimen

Estimated Enrollment: 10
Study Start Date: July 2012
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nelfinavir
This is a single arm intervention trial of nelfinavir in women with grade 2/3 or grade 3 cervical intraepithelial neoplasia
Drug: Nelfinavir

All medications which a patient is taking will be reviewed at each visit, including the screening, day 1, weeks 4,12, 24.

All patients enrolled in the study will receive 1,250 mg twice PO daily for a 24 week duration.

Other Name: Viracept

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have a Cytology report with a High Grade Squamous Intra Epithelial Lesion "HSIL" or have histologically proven CIN 2/3 or CIN 3 diagnosed by cervical biopsy between 2 and 8 weeks prior to enrollment. For a patient to be eligible, the Cytology report must state High Grade Squamous Intra Epithelial Lesion "HSIL" or the pathology report must clearly state "CIN 2/3" or "CIN 3" or must state "moderate-severe dysplasia", "moderate severe dyskaryosis," "severe dysplasia," or "severe dyskaryosis." Patients with a diagnosis of CIN 2 alone or moderate dysplasia or dyskaryosis alone are not eligible for this study.
  • Patients must be at least 18 years of age.
  • Patients must have a satisfactory (readable, good quality) colposcopic evaluation at least 14 days after diagnostic biopsy.
  • Patients must have colposcopically visible cervical lesion at entry consistent with biopsy.
  • Patients must have a negative urine pregnancy test within 14 days of starting the NFV. Women of childbearing potential must practice an acceptable form of contraception (e.g. intrauterine device, contraceptive pills, diaphragm, condoms).
  • Patients must have a GOG Performance Status of 0, 1, or 2.
  • Patients must be good candidates for delayed treatment of their CIN, i.e. they must be reliable to return for follow-up and provide a combination of at least three phone numbers or addresses for contact.
  • Patients must have adequate*:
  • CBC/Platelets: Hemoglobin (HgB) greater than 10.0g/dl; white blood cell (WBC) count greater than 3000/mcl; Platelet count greater than 125,000/mcl.
  • Renal function: Creatinine less than or equal to 1.5 x Upper Limit Normal (ULN).
  • Hepatic function: Total bilirubin less than or equal to 1.5 x ULN excluding Gilbert's disease; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.0 x ULN.
  • Glycemic control: fasting glucose < 126; random glucose <200; hemoglobin A1C ≤ 7.0%

    *These lab results must be evaluated prior to patient enrollment.

  • Patients must have signed an approved informed consent and authorization permitting release of personal health information.
  • Patients must have a negative HIV test within 14 days of starting the NFV.
  • Patients with allergies or known sensitivity to Nelfinavir will be excluded or withdrawn after treatment, if deemed a safety concern by the principal Investigator.

Exclusion Criteria:

Ineligible Patients

  • Patients who are pregnant or breast-feeding.
  • Patients with cytologic or biopsy evidence of endocervical dysplasia or invasive cancer.
  • Patients with undiagnosed abnormal vaginal bleeding.
  • Patients with a known immunocompromised condition or a positive HIV test. Patients with a prior history of cervical cancer.
  • Patients with a chronic or acute renal, or hepatic disorder, a significant bleeding disorder, or any other condition which in the Investigator's opinion might preclude study participation for the duration of the trial.
  • Patients taking concurrent medication that is metabolized by the CYP3A4 isoenzyme.
  • Patients taking the following concurrent medications: astemizole, cisapride, salmeterol, alfuzosin, terfinadine, amiodarone, midazolam, quinadine, ergot derivatives, pimozide, rifampin, triazolam, warfarin, azithromycin, carbamezpine, cyclosporine, didanosine, fluticasone propionate, phenobarbital, phenytoin, trazadone, sirolimus, tacrolimus , and St. John's wart.
  • Patients who are unwilling, or unable, to practice an acceptable form of contraception (e.g. intrauterine device, contraceptive pills, diaphragm, condoms). For those women who choose to use oral contraceptive pills, they will be encouraged to use a second form of contraception, such as condoms, because of the potential for altered serum levels of oral contraceptives.
  • Patients with uncontrolled diabetes; as defined by hemoglobin A1C ≥ 7.1%
  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 identifier: NCT01925378

Contact: Joseph A Lucci, MD 7135005691
Contact: Sonia C Robazetti, MD, CCRC 7135006382

United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Joseph A. Lucci, MD    713-500-5691   
Contact: Sonia C Robazetti, MD,CCRC    7135006382   
Sponsors and Collaborators
Joseph Anthony Lucci III
The University of Texas Health Science Center, Houston
Principal Investigator: Joseph A Lucci, MD The University of Texas Health Science Center, Houston
  More Information

Responsible Party: Joseph Anthony Lucci III, Professor and Director Division of Gynecologic Oncology, The University of Texas Health Science Center, Houston Identifier: NCT01925378     History of Changes
Other Study ID Numbers: 20110917-01
Study First Received: April 30, 2013
Last Updated: February 22, 2017

Keywords provided by The University of Texas Health Science Center, Houston:
Cervical Dysplasia

Additional relevant MeSH terms:
Uterine Cervical Dysplasia
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Precancerous Conditions
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents processed this record on April 28, 2017