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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00054041
First received: February 5, 2003
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Cervical Cancer
Cervical Intraepithelial Neoplasia Grade 3
Human Papilloma Virus Infection
Biological: HspE7
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Evaluation Of SGN-00101 (HSP-E7) Fusion Protein In Women With Cervical Intraepithelial Neoplasia 3, CIN 3

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Complete histologic regression of all CIN 3 lesions [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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.

  • Frequency and severity of adverse events assessed by Common Toxicity Criteria (CTC) version 2.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 84
Study Start Date: June 2004
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Biological: HspE7
Given subcutaneously
Other Names:
  • HPV 16 E7/HSP65 Vaccine
  • HPV E7 Peptide Epitope Vaccine
  • SGN-00101
Procedure: therapeutic conventional surgery
Undergo large loop excision
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm II (control)
Patients receive standard care. At week 15, all patients undergo large loop excision of the transformation zone under colposcopy.
Procedure: therapeutic conventional surgery
Undergo large loop excision
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054041

Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Investigators
Principal Investigator: Cornelia Trimble Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00054041     History of Changes
Other Study ID Numbers: NCI-2012-02513, GOG-0197, U10CA027469, CDR0000269709
Study First Received: February 5, 2003
Last Updated: January 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Neoplasms
Virus Diseases
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Papillomavirus Infections
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
DNA Virus Infections
Tumor Virus Infections

ClinicalTrials.gov processed this record on September 18, 2014