Head and Neck Cancer Clinical Trial
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
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.
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.
;
Primary Purpose: Treatment
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