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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00019110 |
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 |
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Anal Cancer Cervical Cancer Esophageal Cancer Head and Neck Cancer Penile Cancer Vulvar Cancer |
Biological: human papillomavirus 16 E7 peptide Biological: synthetic human papillomavirus 16 E6 peptide |
Phase I |
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 |
Study Start Date: | November 1995 |
OBJECTIVES:
OUTLINE: Patients are stratified according to disease category as defined by the following:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Immunologic:
No autoimmune disease, e.g.:
Responsive to 1 of the following skin test antigens:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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 |
Study Chair: | Barry L. Gause, MD | National Cancer Institute (NCI) |
Study ID Numbers: | CDR0000064330, NCI-95-C-0154, NCI-T94-0134N |
Study First Received: | July 11, 2001 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00019110 History of Changes |
Health Authority: | United States: Federal Government |
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 |
Genital Neoplasms, Male Laryngeal Carcinoma Rectal Neoplasms Gastrointestinal Diseases Esophageal Neoplasms Vulvar Cancer Urogenital Neoplasms Anal Cancer Squamous Cell Carcinoma Rectal Diseases Hypopharyngeal Cancer Genital Diseases, Female Carcinoma, Adenoid Cystic Vulvar Neoplasms Penile Neoplasms |
Papilloma Salivary Gland Diseases Nasopharyngeal Carcinoma Digestive System Neoplasms Rectal Neoplasm Genital Neoplasms, Female Esophageal Cancer Carcinoma, Basal Cell Genital Diseases, Male Granuloma Intestinal Diseases Recurrence Intestinal Neoplasms Carcinoma Rectal Cancer |
Genital Neoplasms, Male Rectal Neoplasms Gastrointestinal Diseases Esophageal Neoplasms Urogenital Neoplasms Rectal Diseases Genital Diseases, Female Neoplasms by Site Vulvar Neoplasms Penile Neoplasms Digestive System Neoplasms Genital Neoplasms, Female Intestinal Diseases |
Genital Diseases, Male Penile Diseases Intestinal Neoplasms Neoplasms Digestive System Diseases Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Anus Neoplasms Anus Diseases Vulvar Diseases Colorectal Neoplasms |