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VACCINE THERAPY AND DETECTION OF IMMUNOLOGIC RESPONSES WITH HUMAN PAPILLOMAVIRUS 16 E6 AND E7 PEPTIDES IN PATIENTS WITH METASTATIC OR LOCALLY ADVANCED CERVICAL CANCER


Phase 1
18 Years
N/A
Not Enrolling
Female
Anal Cancer, Cervical Cancer, Esophageal Cancer, Head and Neck Cancer, Penile Cancer, Vulvar Cancer

Thank you

Trial Information

VACCINE THERAPY AND DETECTION OF IMMUNOLOGIC RESPONSES WITH HUMAN PAPILLOMAVIRUS 16 E6 AND E7 PEPTIDES IN PATIENTS WITH METASTATIC OR LOCALLY ADVANCED CERVICAL CANCER


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Barry L. Gause, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000064330

NCT ID:

NCT00019110

Start Date:

November 1995

Completion Date:

Related Keywords:

  • Anal Cancer
  • Cervical Cancer
  • Esophageal Cancer
  • Head and Neck Cancer
  • Penile Cancer
  • Vulvar Cancer
  • 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
  • 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
  • recurrent verrucous carcinoma of the oral cavity
  • recurrent mucoepidermoid carcinoma of the oral cavity
  • recurrent adenoid cystic carcinoma of the oral cavity
  • stage III squamous cell carcinoma of the oropharynx
  • stage III lymphoepithelioma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage IV lymphoepithelioma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • recurrent lymphoepithelioma of the oropharynx
  • stage III squamous cell carcinoma of the nasopharynx
  • stage III lymphoepithelioma of the nasopharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • stage IV lymphoepithelioma of the nasopharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • recurrent lymphoepithelioma of the nasopharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the larynx
  • stage III verrucous carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV verrucous carcinoma of the larynx
  • recurrent squamous cell carcinoma of the larynx
  • recurrent verrucous carcinoma of the larynx
  • stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage III inverted papilloma of the paranasal sinus and nasal cavity
  • stage III midline lethal granuloma of the paranasal sinus and nasal cavity
  • stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV inverted papilloma of the paranasal sinus and nasal cavity
  • stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
  • stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent inverted papilloma of the paranasal sinus and nasal cavity
  • recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
  • recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • recurrent salivary gland cancer
  • stage IV salivary gland cancer
  • stage III salivary gland cancer
  • Anus Neoplasms
  • Uterine Cervical Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Head and Neck Neoplasms
  • Vulvar Neoplasms
  • Penile Neoplasms

Name

Location

Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Morristown Memorial HospitalMorristown, New Jersey  07962-1956
University of Texas Medical BranchGalveston, Texas  77555-1329
Brigham and Women's HospitalBoston, Massachusetts  02115
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182
Center for Cancer ResearchBethesda, Maryland  20892