Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia

NCT ID: NCT00054041

Last Updated: 2013-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30

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

Detailed Description

PRIMARY OBJECTIVES:

I. Determine the efficacy of SGN-00101, in terms of complete histologic regression, in patients with grade III cervical intraepithelial neoplasia.

II. Determine the toxicity of this drug in these patients.

SECONDARY OBJECTIVES:

I. Determine change in lesion size in these patients after treatment with this drug.

II. Compare histologic response before and after treatment with this drug in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive SGN-00101 subcutaneously once on weeks 1, 4, and 8 in the absence of disease progression.

Arm II: Patients receive standard care.

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

Patients are followed at 19 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 28-84 patients (14-42 per treatment arm) will be accrued for this study within 12-48 months.

Conditions

Cervical Cancer; Cervical Intraepithelial Neoplasia Grade 3; Human Papilloma Virus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I (HspE7)

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.

Group Type: EXPERIMENTAL

HspE7

Intervention Type: BIOLOGICAL

Given subcutaneously

therapeutic conventional surgery

Intervention Type: PROCEDURE

Undergo large loop excision

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Arm II (control)

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

Group Type: EXPERIMENTAL

therapeutic conventional surgery

Intervention Type: PROCEDURE

Undergo large loop excision

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

HspE7

Given subcutaneously

Intervention Type: BIOLOGICAL

therapeutic conventional surgery

Undergo large loop excision

Intervention Type: PROCEDURE

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

HPV 16 E7/HSP65 Vaccine; HPV E7 Peptide Epitope Vaccine; SGN-00101

Eligibility Criteria

Inclusion Criteria

• 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
• No prior or concurrent severe allergic disease
• No concurrent human papilloma viral infection other than type 16
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No life-threatening or serious gastrointestinal disorder
• No life-threatening or serious endocrine disorder
• No invasive malignancy within the past 5 years except nonmelanoma skin cancer
• No concurrent chronic or systemic steroids
• No prior organ transplantation
• No prior cancer therapy that would preclude study therapy

• Minimum Eligible Age: 17 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cornelia Trimble

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

Gynecologic Oncology Group

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40313865 (View on PubMed)

Other Identifiers

GOG-0197

Identifier Type: -

Identifier Source: secondary_id

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000269709

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02513

Identifier Type: -

Identifier Source: org_study_id