Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Alternate Title

Vaccine Therapy in Treating Patients With Cervical or Vulvar Neoplasia

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed 18 and over NCI LAC-USC-5C952 NCI-T96-0033, T96-0033

Objectives

I. Determine the maximum tolerated dose of human papillomavirus 16 E7 (HPV-16 
E7) peptide vaccine comprised of HPV-16 E7(12-20) peptide when combined with 
E7(86-93) lipopeptide in HLA A-2, HPV-16 positive patients with stage II or 
stage III cervical or vulvar squamous intraepithelial neoplasia.

II. Evaluate the toxicity and tolerability of this regimen in these patients. 

III. Evaluate the immune reactivity to this regimen in these patients.  

IV. Evaluate the possible therapeutic efficacy of escalating doses of this 
vaccine in these patients.

Entry Criteria

Disease Characteristics:

Histologically proven cervical intraepithelial neoplasia (CIN) or vulvar
intraepithelial neoplasia 
 Stage II or III

Lesion must be completely delineated by colposcopy after biopsy OR
Positive cytology for SIL II without measurable lesions

CIN patients must be negative for preinvasive changes or invasive carcinoma

No change in CIN lesion 1 month following initial biopsy, colposcopy, and 
cytologic exam 

No endocervical curettage indicating preinvasive changes or invasive cancer 

HPV-16 positive by analysis of cervical or vulvar scrapings or biopsy

HLA-A2 positive 

Prior/Concurrent Therapy:

Biological therapy:
 Not specified

Chemotherapy:
 Not specified

Endocrine therapy:
 Not specified

Radiotherapy:
 No prior pelvic irradiation

Surgery:
 Not specified

Other:
 At least 90 days since prior treatment for cervical dysplasia
 No prior in utero diethylstilbestrol exposure
 

Patient Characteristics:

Age:
 18 and over

Performance status:
 EGOG 0-1

Life expectancy:
 Not specified

Hematopoietic:
 Platelet count greater than 100,000/mm3
 Hemoglobin greater than 8.5 g/dL
 
Hepatic:
 Bilirubin less than 2.0 mg/dL
 SGOT less than 2.5 times normal
 PT less than 2.5 times normal

Renal:
 Creatinine less than 1.4 mg/dL

Other:
 No prior or concurrent genital malignancy
 No prior invasive cancer within the past 5 years
 Not pregnant 
 Fertile patients must use effective contraception for the duration of the
  study (6 months)

Expected Enrollment

A total of 15-20 patients will be accrued for this study within 1.5 years.

Outline

This is a dose escalation study of human papillomavirus 16 E7 (HPV-16 E7) 
peptide vaccine. 

Patients receive HPV-16 E7 peptide vaccine comprised of HPV-16 E7(12-20) 
peptide emulsified in Montanide ISA-51 via deep subcutaneous (SQ) injection 
and E7(86-93) lipopeptide via separate deep SQ injection.  Treatment repeats 
every 3 weeks for 4 courses.  

Cohorts of 3-6 patients receive escalating doses of HPV-16 E7 peptide vaccine 
until the maximum tolerated dose (MTD) is determined.  The MTD is defined as 
the dose preceding that at which at least 2 of 3-6 patients experience dose 
limiting toxicity.

Patients are followed at 3 weeks, and then at 3, 6, and 12 months.

Trial Contact Information

Trial Lead Organizations

USC/Norris Comprehensive Cancer Center and Hospital

Laila Muderspach, MD, Protocol chair		Ph: 323-865-3922; 800-865-0102