Vaccine Therapy in Treating Patients With Advanced or Recurrent Cancer
This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00019110
First received: July 11, 2001
Last updated: September 2, 2012
Last verified: November 1999
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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 |
Biological: human papillomavirus 16 E7 peptide Biological: synthetic human papillomavirus 16 E6 peptide |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Anal Cancer
Benign Tumors
Cancer
Cervical Cancer
Esophageal Cancer
Esophagus Disorders
Head and Neck Cancer
Vulvar Cancer
Drug Information available for:
Human Papillomaviruses
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | November 1995 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- ECOG 0-1
Life expectancy:
- More than 3 months
Hematopoietic:
- WBC at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- SGPT no greater than 4 times normal
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
- No myocardial infarction within the past 6 months
- No New York Heart Association class III or IV heart disease
Immunologic:
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
Other:
- 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
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy and recovered
Chemotherapy:
- At least 4 weeks since prior chemotherapy and recovered
Endocrine therapy:
- At least 4 weeks since prior steroids and recovered
Radiotherapy:
- At least 4 weeks since prior radiotherapy and recovered
Surgery:
- Not specified
Other:
- Recovered from the toxic effects of prior therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00019110
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 | |
Sponsors and Collaborators
Investigators
| Study Chair: | Barry L. Gause, MD | National Cancer Institute (NCI) |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00019110 History of Changes |
| Obsolete Identifiers: | NCT00001441 |
| Other Study ID Numbers: | CDR0000064330, NCI-95-C-0154, NCI-T94-0134N |
| Study First Received: | July 11, 2001 |
| Last Updated: | September 2, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 IVB 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 |
Additional relevant MeSH terms:
|
Anus Neoplasms Uterine Cervical Neoplasms Esophageal Diseases Esophageal Neoplasms Head and Neck Neoplasms Vulvar Neoplasms Penile Neoplasms Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Intestinal Diseases Anus Diseases Rectal Diseases Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Vulvar Diseases Genital Neoplasms, Male Genital Diseases, Male Penile Diseases |
ClinicalTrials.gov processed this record on May 23, 2013