Vaccine Therapy in Treating Patients With Advanced or Recurrent Cancer

Phase 1

Completed

• Conditions: Vulvar Cancer; Head and Neck Cancer; Anal Cancer; Penile Cancer; Cervical Cancer; Esophageal Cancer

• Registration Number: NCT00019110
• Lead Sponsor: National Cancer Institute (NCI)

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

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.

Study Timeline

• Study Start: 1995-11
• Status Verified: 1999-11
• Study First Submitted: 2001-07-11
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Last Update Submitted: 2015-04-28
• Last Update Posted: 2015-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (6)

Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support; 🇺🇸 Bethesda, Maryland, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States

Morristown Memorial Hospital; 🇺🇸 Morristown, New Jersey, United States

Center for Cancer Research; 🇺🇸 Bethesda, Maryland, United States