SGN-00101 Immunotherapy in Treating Patients With Grade III Cervical Intraepithelial Neoplasia

Phase 2

Completed

• Conditions: Precancerous Condition; Cervical Cancer
• Interventions: Biological: HspE7

• Registration Number: NCT00075569
• Lead Sponsor: Albert Einstein College of Medicine

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer or to treat early cancer. SGN-00101 may be effective in preventing the development of cervical cancer in patients who have cervical intraepithelial neoplasia.

PURPOSE: This phase II trial is studying how well SGN-00101 immunotherapy works in preventing cervical cancer in patients with grade III cervical intraepithelial neoplasia.

Detailed Description

OBJECTIVES:

Primary

* Determine the rate of regression at 4-7 months in patients with grade III cervical intraepithelial neoplasia (CIN III) treated with SGN-00101 immunotherapy.

* Compare the rate of regression at 4-7 months with expected outcome in patients immunized with this vaccine.

* Determine the toxic effects and recovery from possible toxic effects of this vaccine in these patients.

Secondary

* Determine induction of cell-mediated immune responses against human papillomavirus (HPV) E7 peptides before and after treatment in patients immunized with this vaccine

* Correlate regression of disease with enhanced immunologic responses in patients immunized with this vaccine.

* Correlate seropositivity of HPV-16 virus-like particles (VLP16) with vaccine-induced regression of CIN III in patients immunized with this vaccine.

* Determine the efficacy of this vaccine in patients whose CIN III is associated with HPV-16 infection vs other HPV types.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 treatment groups.

All patients receive SGN-00101 subcutaneously once monthly on months 1-3 (for a total of 3 vaccinations) in the absence of disease progression or unacceptable toxicity.

* Group 1: Four months after the first vaccination, patients undergo therapeutic and diagnostic loop electrosurgical excision procedure (LEEP) or core biopsy.

* Group 2: Six months after the first vaccination, patients undergo therapeutic and diagnostic LEEP or core biopsy.

Patients in group 1 are followed at 12 months and patients in group 2 are followed at 14 months after the first vaccination.

PROJECTED ACCRUAL: A total of 66 patients (36 for group 1 and 30 for group 2) will be accrued for this study.

Study Timeline

• Study First Submitted: 2004-01-09
• Study First Submitted QC: 2004-01-11
• Study First Posted: 2004-01-12
• Study Start: 2004-03
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Status Verified: 2006-01
• Last Update Submitted: 2018-05-17
• Last Update Posted: 2018-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 month follow-up	HspE7	3 monthly subcutaneous vaccinations with 500 microg of HspE7 followed by monthly colposcopic follow-up for 1 month; followed by LEEP or cone biopsy
2 month follow-up	HspE7	3 monthly subcutaneous vaccinations with 500 microg of HspE7 followed by monthly colposcopic follow-up for 2 months; followed by LEEP or cone biopsy

Primary Outcome Measures

Name	Time	Method
Rate of regression	4 months after completion of treatment
Toxicity	4 months after completion of treatment

Trial Locations

Locations (2)

Albert Einstein Cancer Center at Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States

New York Weill Cornell Cancer Center at Cornell University; 🇺🇸 New York, New York, United States