A Phase II Single-arm Intervention Trial of Nelfinavir in Patients With Grade 2/3 or 3 Cervical Intraepithelial Neoplasia
Verified June 2015 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
First received: April 30, 2013
Last updated: June 18, 2015
Last verified: June 2015
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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A PHASE II SINGLE-ARM INTERVENTION TRIAL OF NELFINAVIR IN PATIENTS WITH GRADE 2/3 or 3 CERVICAL INTRAEPITHELIAL NEOPLASIA
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 ] [ Designated as safety issue: No ]
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:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2016 (Final data collection date for primary outcome measure)
This is a single arm intervention trial of nelfinavir in women with grade 2/3 or grade 3 cervical intraepithelial neoplasia
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
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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%
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: NCT01925378
Joseph Anthony Lucci III
The University of Texas Health Science Center, Houston
||Joseph A Lucci, MD
||The University of Texas Health Science Center, Houston
||Joseph Anthony Lucci III, Professor and Director Division of Gynecologic Oncology, The University of Texas Health Science Center, Houston
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 30, 2013
||June 18, 2015
||United States: Food and Drug Administration
Keywords provided by The University of Texas Health Science Center, Houston:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 04, 2016
Uterine Cervical Dysplasia
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Genital Diseases, Female
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Uterine Cervical Diseases
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action