NCT00054041

Brief Summary

Vaccines made from antigens may make the body build an immune response to kill abnormal cervical cells and may be effective in preventing cervical cancer. Randomized phase II trial to study the effectiveness of vaccine therapy in preventing cervical cancer in patients who have cervical intraepithelial neoplasia

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2003

Completed
1.3 years until next milestone

Study Start

First participant enrolled

June 1, 2004

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

2.6 years

First QC Date

February 5, 2003

Last Update Submit

January 23, 2013

Conditions

Cervical CancerCervical Intraepithelial Neoplasia Grade 3Human Papilloma Virus Infection

Outcome Measures

Primary Outcomes (2)

  • Complete histologic regression of all CIN 3 lesions

    Fisher's exact test (and if feasible, Chi-Square test) will be conducted to see if the probability of responding in the investigational arm is significantly different from the controls actively accrued to this study. The conditional distribution used in Fisher's exact test will be used to calculate a 90% confidence interval for the odds ratio of observing a response in the investigational arm to the control arm.

    Up to 3 years

  • Frequency and severity of adverse events assessed by Common Toxicity Criteria (CTC) version 2.0

    Up to 3 years

Study Arms (2)

Arm I (HspE7)

EXPERIMENTAL

Patients receive SGN-00101 subcutaneously once on weeks 1, 4, and 8 in the absence of disease progression. At week 15, all patients undergo large loop excision of the transformation zone under colposcopy.

Biological: HspE7Procedure: therapeutic conventional surgeryOther: laboratory biomarker analysis

Arm II (control)

EXPERIMENTAL

Patients receive standard care. At week 15, all patients undergo large loop excision of the transformation zone under colposcopy.

Procedure: therapeutic conventional surgeryOther: laboratory biomarker analysis

Interventions

HspE7BIOLOGICAL

Given subcutaneously

Also known as: HPV 16 E7/HSP65 Vaccine, HPV E7 Peptide Epitope Vaccine, SGN-00101
Arm I (HspE7)
therapeutic conventional surgeryPROCEDURE

Undergo large loop excision

Arm I (HspE7)Arm II (control)
laboratory biomarker analysisOTHER

Correlative studies

Arm I (HspE7)Arm II (control)

Eligibility Criteria

Age17 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed grade III cervical intraepithelial neoplasia
  • Confirmed by biopsy or colposcopy
  • Positive for human papilloma virus 16
  • No endocervical glandular dysplasia
  • No adenocarcinoma in situ
  • Performance status - GOG 0-2
  • No life-threatening or serious hematological disorder
  • No life-threatening or serious hepatic disorder
  • No life-threatening or serious renal disorder
  • No life-threatening or serious cardiac disorder
  • No life-threatening or serious respiratory disorder
  • HIV negative
  • Must be immunocompetent
  • No history of autoimmune disease
  • No life-threatening or serious immunological disorder
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

Related Publications (1)

  • Roy AA, Pandey A, Dhas N, Hegde MM, Parekh HS, Andugulapati SB, Nandakumar K, Satish Rao BS, Mutalik S. The Confluence of Nanotechnology and Heat Shock Protein 70 in Pioneering Glioblastoma Multiforme Therapy: Forging Pathways Towards Precision Targeting and Transformation. Adv Pharmacol Pharm Sci. 2025 Apr 24;2025:1847197. doi: 10.1155/adpp/1847197. eCollection 2025.

    PMID: 40313865DERIVED

MeSH Terms

Conditions

Uterine Cervical NeoplasmsUterine Cervical DysplasiaPapillomavirus Infections

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPrecancerous ConditionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Cornelia Trimble

    Gynecologic Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2003

First Posted

February 6, 2003

Study Start

June 1, 2004

Primary Completion

January 1, 2007

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

US(1)