Vaccine Therapy in Treating Patients With Advanced or Recurrent Cancer

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Brief Title

Vaccine Therapy in Treating Patients With Advanced or Recurrent Cancer

Official Title


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.

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

        -  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 Phase

Phase 1

Study Type



Anal Cancer


human papillomavirus 16 E7 peptide


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Start Date

November 1995

Eligibility Criteria


          -  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




18 Years - N/A

Accepts Healthy Volunteers



Barry L. Gause, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs


Study Sponsor

National Cancer Institute (NCI)

Study Sponsor

Barry L. Gause, MD, Study Chair, National Cancer Institute (NCI)

Verification Date

November 1999