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

National Cancer Institute (NCI)

Status and phase

Completed

Phase 2

Conditions

Cervical Intraepithelial Neoplasia Grade 3

Human Papilloma Virus Infection

Cervical Cancer

Treatments

Biological: HspE7

Other: laboratory biomarker analysis

Procedure: therapeutic conventional surgery

Study type

Interventional

Funder types

NIH

Identifiers

NCT00054041

NCI-2012-02513

U10CA027469 (U.S. NIH Grant/Contract)

CDR0000269709 (Registry Identifier)

GOG-0197

Details and patient eligibility

About

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

Full 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.

Enrollment

84 patients

Sex

Female

Ages

17+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

84 participants in 2 patient groups

Arm I (HspE7)

Experimental group

Description:

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.

Treatment:

Other: laboratory biomarker analysis

Biological: HspE7

Procedure: therapeutic conventional surgery

Arm II (control)

Experimental group

Description:

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

Treatment:

Other: laboratory biomarker analysis

Procedure: therapeutic conventional surgery