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Vaccine Therapy in Treating Patients With Advanced or Recurrent Cancer
This study has been completed.
First Received: July 11, 2001   Last Updated: February 6, 2009   History of Changes
Sponsor: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00019110
  Purpose

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 Intervention 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 I

Study Type: Interventional
Study Design: Treatment
Official Title: VACCINE THERAPY AND DETECTION OF IMMUNOLOGIC RESPONSES WITH HUMAN PAPILLOMAVIRUS 16 E6 AND E7 PEPTIDES IN PATIENTS WITH METASTATIC OR LOCALLY ADVANCED CERVICAL CANCER

Resource links provided by NLM:

MedlinePlus related topics: Anal Cancer Cancer Esophageal Cancer Esophagus Disorders Head and Neck Cancer Tonsils and Adenoids Vulvar Cancer
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 1995
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • ECOG 0-1

Life expectancy:

  • More than 3 months

Hematopoietic:

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

Hepatic:

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

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

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

Immunologic:

  • 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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy and recovered

Chemotherapy:

  • At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

  • At least 4 weeks since prior steroids and recovered

Radiotherapy:

  • At least 4 weeks since prior radiotherapy and recovered

Surgery:

  • Not specified

Other:

  • Recovered from the toxic effects of prior therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00019110

Locations
United States, Maryland
Center for Cancer Research
Bethesda, Maryland, United States, 20892
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114-2617
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)
Investigators
Study Chair: Barry L. Gause, MD National Cancer Institute (NCI)
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: CDR0000064330, NCI-95-C-0154, NCI-T94-0134N
Study First Received: July 11, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00019110     History of Changes
Health Authority: United States: Federal Government

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 IV 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
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
stage IV mucoepidermoid carcinoma of the oral cavity
recurrent squamous cell carcinoma of the lip and oral cavity
recurrent basal cell carcinoma of the lip

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

ClinicalTrials.gov processed this record on November 09, 2009



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