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Completed

NCT Number: NCT00121173

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

RATIONALE: Vaccines made from protein and DNA may help the body build an effective immune response to kill abnormal cells in the cervix. The use of vaccine therapy may prevent cervical cancer.

PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy and to see how well it works in preventing cervical cancer in patients with cervical intraepithelial neoplasia and human papillomavirus.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Precancerous Condition Precancerous Conditions Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–120 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

About this study

OBJECTIVES:

Primary

  • Determine the feasibility and toxicity of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine in preventing cervical cancer in patients with human papillomavirus (HPV)-16-positive grade 2 or 3 cervical intraepithelial neoplasia.
  • Determine the effect of this vaccine on the histology of cervical tissue specimens from these patients.

Secondary

  • Determine changes in lesion size and HPV viral load in patients treated with this vaccine.
  • Determine the cellular, humoral, and local tissue immune responses in patients treated with this vaccine.
  • Correlate measures of immune response with clinical response in patients treated with this vaccine.
  • Correlate measures of immune response in patients treated with this vaccine with those observed in the preclinical model.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

  • Phase I: Patients receive pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine subcutaneously once in weeks 0, 4, and 8 in the absence of disease progression or unacceptable toxicity. Patients undergo colposcopy in week 8, 15 and 19 and a therapeutic loop electrosurgical excision procedure (LEEP) in week 15.

Cohorts of patients receive escalating doses of vaccine until the safest dose is determined.

  • Phase II: Patients receive vaccine as in phase I but at the safest dose determined in phase I. Patients also undergo colposcopy and LEEP as in phase I.

After completion of the study treatment, patients are followed annually for 15 years.

PROJECTED ACCRUAL: Approximately 150 patients (approximately 12 will be treated in phase I and 25 will be treated in phase II) will be accrued for this study.

Who can participate

Healthy volunteers accepted: No

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed cervical intraepithelial neoplasia (CIN2/3)
  • Human papillomavirus-16-positive disease

PATIENT CHARACTERISTICS:

  • Age: > 18

Other

  • Not pregnant
  • Immunocompetent

Treatment and study plan

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

Biological

recombinant DNA vaccine

Primary outcomes

  1. Safety and Toxicity

    Time frame: for the duration of the study, and whenever possible, for an additional 5 years

    Number of participants with serious adverse events (SAE) according to CTCAE 3.0 grading.

  2. Efficacy

    Time frame: for the duration of the study, and whenever possible, for an additional 5 years

    The efficacy of pNGVL4a-SigE7(detox)HSP70 DNA vaccine, administered intra-muscularly. This is reported as number of participants with histologic regression of CIN2/3 to CIN1 or less by colposcopically-directed biopsy.

Secondary outcomes

  1. Regression of CIN3 Lesions

    Time frame: 15 weeks

    Number of participants with absence of CIN3 lesions at week 15

  2. Number of Participants With T-cell Immune Responses in the Blood

    Time frame: 41 weeks

    Systemic T-cell response as measured by γ-INF enzyme-linked immunospot assays (ELISpot)

  3. Number of Participants With Correlated Measures of Immune Response With Clinical Response

    Time frame: 9 months

    Number of participants whose t-cell immune responses correlated with histologic regression of disease or viral clearance of HPV

  4. Number of Participants With Correlated Measures of Immune Responses With the Preclinical Model

    Time frame: 9 months

    Number of participants whose T-cell immune responses correlated with the immune responses observed in the preclinical model

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Phase I/II Clinical Trial of pNGVL4a-Sig/E7 (Detox)/HSP70 for the Treatment of Patients With HPV 16+ Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)

Important dates

Study start
2003
Primary completion
2010
Study completion
2010
First posted
Jul 21, 2005
Registry last updated
Jul 20, 2018

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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