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NCT Number: NCT00054041

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

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

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Key information

Conditions

Cervical Cancer Cervical Intraepithelial Neoplasia Grade 3 Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Human Papilloma Virus Infection Infections Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Precancerous Conditions Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

17 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HspE7

Biological

Given subcutaneously

Other names: HPV 16 E7/HSP65 Vaccine, HPV E7 Peptide Epitope Vaccine, SGN-00101

therapeutic conventional surgery

Procedure

Undergo large loop excision

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. Complete histologic regression of all CIN 3 lesions

    Time frame: Up to 3 years

    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.

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

    Time frame: Up to 3 years

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

Phase II Evaluation Of SGN-00101 (HSP-E7) Fusion Protein In Women With Cervical Intraepithelial Neoplasia 3, CIN 3

Important dates

Study start
2004
Primary completion
2007
First posted
Feb 6, 2003
Registry last updated
Jan 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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