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| Sponsors and Collaborators: |
NCI - Center for Cancer Research-Medical Oncology National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00019110 |
Purpose
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 |
|
Anal Cancer Cervical Cancer Esophageal Cancer Head and Neck Cancer Penile Cancer Vulvar Cancer |
Drug: human papillomavirus 16 E7 peptide Drug: synthetic human papillomavirus 16 E6 peptide |
Phase I |
| MedlinePlus related topics: | Anal Cancer Cancer Cervical Cancer Esophageal Cancer Esophagus Disorders Head and Neck Cancer Salivary Gland Disorders Vulvar Cancer |
| Drug Information available for: | Salicylsalicylic acid Sodium salicylate |
| 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 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.
Eligibility
| 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:
Contacts and Locations| 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 | |||||
| NCI - Center for Cancer Research-Medical Oncology |
| National Cancer Institute (NCI) |
| Study Chair: | Barry L. Gause, MD | NCI - Center for Cancer Research-Medical Oncology |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000064330, NCI-95-C-0154, NCI-T94-0134N |
| First Received: | July 11, 2001 |
| Last Updated: | October 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00019110 |
| Health Authority: | United States: Federal Government |
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