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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)


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Cervical Cancer, Precancerous Condition

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Trial Information

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)


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Toxicity

Outcome Time Frame:

01/2010

Safety Issue:

Yes

Principal Investigator

Cornelia L. Trimble, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

J0323 CDR0000439494

NCT ID:

NCT00121173

Start Date:

November 2003

Completion Date:

January 2010

Related Keywords:

  • Cervical Cancer
  • Precancerous Condition
  • cervical cancer
  • cervical intraepithelial neoplasia grade 2
  • cervical intraepithelial neoplasia grade 3
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Precancerous Conditions
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410