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Vaccine Therapy in Treating Patients With Advanced or Recurrent Cancer

This study has been completed.

Sponsors and Collaborators: NCI - Center for Cancer Research-Medical Oncology
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
Drug: human papillomavirus 16 E7 peptide
Drug: synthetic human papillomavirus 16 E6 peptide
Phase I

MedlinePlus related topics:   Anal Cancer    Cancer    Cervical Cancer    Esophageal Cancer    Esophagus Disorders    Head and Neck Cancer    Salivary Gland Disorders    Vulvar Cancer   

Drug Information available for:   Salicylsalicylic acid    Sodium salicylate   

U.S. FDA Resources

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

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
NCI - Center for Cancer Research-Medical Oncology
National Cancer Institute (NCI)

Investigators
Study Chair:     Barry L. Gause, MD     NCI - Center for Cancer Research-Medical Oncology    
  More Information


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

Study ID Numbers:   CDR0000064330, NCI-95-C-0154, NCI-T94-0134N
First Received:   July 11, 2001
Last Updated:   October 18, 2008
ClinicalTrials.gov Identifier:   NCT00019110
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

Study placed in the following topic categories:
Genital Neoplasms, Male
Rectal Neoplasms
Gastrointestinal Diseases
Squamous cell carcinoma
Esophageal Neoplasms
Sodium Salicylate
Urogenital Neoplasms
Rectal Diseases
Adenoid cystic carcinoma
Genital Diseases, Female
Uterine Cervical Neoplasms
Uterine Cervical Diseases
Carcinoma, Adenoid Cystic
Vulvar Neoplasms
Metastatic squamous neck cancer with occult primary
Carcinoma, squamous cell
Laryngeal carcinoma
Uterine Neoplasms
Penile Neoplasms
Papilloma
Esophageal neoplasm
Salivary Gland Diseases
Digestive System Neoplasms
Esophageal disorder
Salicylsalicylic acid
Genital Neoplasms, Female
Uterine Diseases
Carcinoma, Basal Cell
Genital Diseases, Male
Granuloma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Penile Diseases
Anus Diseases

ClinicalTrials.gov processed this record on December 03, 2008




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