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Vaccine Therapy in Treating Patients With Advanced or Recurrent Cancer

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ClinicalTrials.gov Identifier: NCT00019110
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 29, 2015
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Vaccines made from certain human papillomaviruses may be able to help the body to kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of human papillomavirus vaccine therapy in treating patients who have advanced or recurrent cancer of the cervix, vagina, penis, anus, esophagus, or head and neck.

Condition or disease Intervention/treatment Phase
Anal Cancer Cervical Cancer Esophageal Cancer Head and Neck Cancer Penile Cancer Vulvar Cancer Biological: human papillomavirus 16 E7 peptide Biological: synthetic human papillomavirus 16 E6 peptide Phase 1

Detailed Description:


  • Determine whether endogenous cellular immunity to the viral oncoproteins human papilloma virus 16 (HPV16) E6 and E7 is present in patients with advanced or recurrent carcinoma of the cervix or other carcinomas that carry HPV16.
  • Determine whether vaccination with antigen-presenting cells pulsed with synthetic peptide corresponding to the tumor's HPV16 E6 or E7 peptide can induce or boost patient cellular immunity to that particular peptide.
  • Determine the type and characteristics of the cellular immunity generated in patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
  • Determine the tumor response in patients treated with this regimen.
  • Determine whether in vivo T cells generated specifically against HPV16 E6 or E7 peptide can be cloned and expanded in vitro against the corresponding peptide.

OUTLINE: Patients are stratified according to disease category as defined by the following:

  • Stratum A: Stage III cervical cancer not previously treated with appropriate radiotherapy; stage IV or recurrent cervical cancer; or other advanced tumors that harbor human papilloma virus 16 (HPV16) such as anogenital, esophageal, or head and neck cancers.
  • Stratum B: Stage III cervical cancer previously treated with standard therapy with no evidence of residual disease. Vaccination in this group is given as adjuvant therapy.

Patients are assigned to receive HPV E6 or E7 peptide by the principal investigator. Peripheral blood mononuclear cells (PBMC) (antigen presenting cells) are harvested and treated in vitro with sargramostim (GM-CSF) and pulsed with HPV16 E6 or E7. Patients receive vaccination with HPV16 E6 or E7 pulsed PBMC IV over 1-2 minutes during weeks 1, 3, 7, and 11 for a total of 4 vaccinations. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) continue treatment for a maximum of 1 year past CR.

Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 40-46 patients (at least 28 patients for stratum A and 12 for stratum B) will be accrued for this study within 1-2 years.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Study Start Date : November 1995

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically proven stage III, IV, or recurrent carcinoma of the cervix or other tumor that carries human papilloma virus 16 (HPV16) such as other anogenital (vulvar, penile, and anal), esophageal, and head and neck cancers
  • HLA-A2.1 positive
  • Patients with tumors other than cervical cancer must have no other therapeutic options
  • Fresh tissue or paraffin block available for HPV genome detection and typing (optional for cervical cancer)
  • No history of CNS metastases



  • Over 18

Performance status:

  • ECOG 0-1

Life expectancy:

  • More than 3 months


  • WBC at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 2.0 mg/dL
  • SGPT no greater than 4 times normal


  • Creatinine no greater than 2.0 mg/dL


  • No myocardial infarction within the past 6 months
  • No New York Heart Association class III or IV heart disease


  • No autoimmune disease, e.g.:

    • Systemic lupus erythematosus
    • Multiple sclerosis
    • Ankylosing spondylitis
    • HIV negative
  • Responsive to 1 of the following skin test antigens:

    • Mumps Trichophyton
    • Candida Tetanus


  • No active infection requiring antibiotics
  • No weight loss greater than 20% within the past 6 months
  • No other active malignancy except basal cell skin cancer
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • At least 4 weeks since prior immunotherapy and recovered


  • At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

  • At least 4 weeks since prior steroids and recovered


  • At least 4 weeks since prior radiotherapy and recovered


  • Not specified


  • Recovered from the toxic effects of prior therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00019110

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Center for Cancer Research
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114-2617
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, New Jersey
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962-1956
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0587
Sponsors and Collaborators
National Cancer Institute (NCI)
Study Chair: Barry L. Gause, MD National Cancer Institute (NCI)

ClinicalTrials.gov Identifier: NCT00019110     History of Changes
Obsolete Identifiers: NCT00001441
Other Study ID Numbers: CDR0000064330
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: November 1999

Keywords provided by National Cancer Institute (NCI):
stage IV anal cancer
recurrent anal cancer
stage II esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer
stage IIIA anal cancer
stage IIIB anal cancer
recurrent esophageal cancer
stage III cervical cancer
stage IV cervical cancer
recurrent cervical cancer
stage III vulvar cancer
stage IVB vulvar cancer
recurrent vulvar cancer
stage III penile cancer
stage IV penile cancer
recurrent penile cancer
recurrent metastatic squamous neck cancer with occult primary
metastatic squamous neck cancer with occult primary squamous cell carcinoma
recurrent salivary gland cancer
stage IV salivary gland cancer
stage III salivary gland cancer
stage III squamous cell carcinoma of the lip and oral cavity
stage III basal cell carcinoma of the lip
stage III verrucous carcinoma of the oral cavity
stage III mucoepidermoid carcinoma of the oral cavity
stage III adenoid cystic carcinoma of the oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage IV basal cell carcinoma of the lip
stage IV verrucous carcinoma of the oral cavity

Additional relevant MeSH terms:
Head and Neck Neoplasms
Uterine Cervical Neoplasms
Esophageal Neoplasms
Anus Neoplasms
Vulvar Neoplasms
Penile Neoplasms
Neoplasms by Site
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Vulvar Diseases
Genital Neoplasms, Male
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
Genital Diseases, Male
Penile Diseases