A Phase II Single-arm Intervention Trial of Nelfinavir in Patients With Grade 2/3 or 3 Cervical Intraepithelial Neoplasia
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A PHASE II SINGLE-ARM INTERVENTION TRIAL OF NELFINAVIR IN PATIENTS WITH GRADE 2/3 or 3 CERVICAL INTRAEPITHELIAL NEOPLASIA|
- 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.
- targeted mechanism of NFV in histological response [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]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
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (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
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|Contact: Joseph De La Garza, MDfirstname.lastname@example.org|
|Contact: Sindy Jaramilloemail@example.com|
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Sindy Jaramillo 305-243-2150 firstname.lastname@example.org|
|Contact: Joseph de la Garza, MD 3052439189|
|Principal Investigator: Joseph Lucci, MD|
|Principal Investigator:||Joseph Lucci, MD||University of Miami|