Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia

Summary: 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.

Detailed description: 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.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed cervical intraepithelial neoplasia
  -  Grade 2 or 3 disease
  -  Human papillomavirus-16-positive disease
  PATIENT CHARACTERISTICS:
  Age
  -  Over 18
  Performance status
  -  Not specified
  Life expectancy
  -  Not specified
  Hematopoietic
  -  Not specified
  Hepatic
  -  Not specified
  Renal
  -  Not specified
  Other
  -  Not pregnant
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  -  Must be immunocompetent
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  Not specified
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  Not specified
  Surgery
  -  No prior hysterectomy

Relevance to patient case: not relevant