Vaccine Therapy in Treating Patients With Advanced or Rec... | NCT00019110 | Trialant
NCT00019110
Sponsor
National Cancer Institute (NCI)
Status
Completed
Last Update Posted
Apr 29, 2015Estimated
Enrollment
Not provided
Phase
Phase 1
Conditions
Anal Cancer
Cervical Cancer
Esophageal Cancer
Head and Neck Cancer
Penile Cancer
Vulvar Cancer
Interventions
human papillomavirus 16 E7 peptide
synthetic human papillomavirus 16 E6 peptide
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00019110
Obsolete or Duplicate NCT IDs
NCT00001441
Organization Study
CDR0000064330
Secondary IDs
ID
Type
Description
Link
NCI-95-C-0154
NCI-T94-0134N
Brief Title
Vaccine Therapy in Treating Patients With Advanced or Recurrent Cancer
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
Acronym
Not provided
Organization
National Cancer Institute (NCI)NIH
Status Module
Record Verification Date
Nov 1999
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 1995
Primary Completion Date
Not provided
Completion Date
Not provided
First Submitted Date
Jul 11, 2001
First Submission Date that Met QC Criteria
Jan 26, 2003
First Posted Date
Jan 27, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 28, 2015
Last Update Posted Date
Apr 29, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
National Cancer Institute (NCI)NIH
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
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.
Conditions Module
Conditions
Anal Cancer
Cervical Cancer
Esophageal Cancer
Head and Neck Cancer
Penile Cancer
Vulvar Cancer
Keywords
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
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
Not provided
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
human papillomavirus 16 E7 peptide
Biological
synthetic human papillomavirus 16 E6 peptide
Biological
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility 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
Accepts Healthy Volunteers
No
Sex
Female
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Barry L. Gause, MD
National Cancer Institute (NCI)
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda
Maryland
20892-1182
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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
recurrent verrucous carcinoma of the oral cavity
recurrent mucoepidermoid carcinoma of the oral cavity
recurrent adenoid cystic carcinoma of the oral cavity
stage III squamous cell carcinoma of the oropharynx
stage III lymphoepithelioma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
stage IV lymphoepithelioma of the oropharynx
recurrent squamous cell carcinoma of the oropharynx
recurrent lymphoepithelioma of the oropharynx
stage III squamous cell carcinoma of the nasopharynx
stage III lymphoepithelioma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
stage IV lymphoepithelioma of the nasopharynx
recurrent squamous cell carcinoma of the nasopharynx
recurrent lymphoepithelioma of the nasopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage III verrucous carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage IV verrucous carcinoma of the larynx
recurrent squamous cell carcinoma of the larynx
recurrent verrucous carcinoma of the larynx
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
stage III inverted papilloma of the paranasal sinus and nasal cavity
stage III midline lethal granuloma of the paranasal sinus and nasal cavity
stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV inverted papilloma of the paranasal sinus and nasal cavity
stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent inverted papilloma of the paranasal sinus and nasal cavity
recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
recurrent salivary gland cancer
stage IV salivary gland cancer
stage III salivary gland cancer
Not provided
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
No data available
No data is available for this block.
Center for Cancer Research
Bethesda
Maryland
20892
United States
Massachusetts General Hospital Cancer Center
Boston
Massachusetts
02114-2617
United States
Brigham and Women's Hospital
Boston
Massachusetts
02115
United States
Morristown Memorial Hospital
Morristown
New Jersey
07962-1956
United States
University of Texas Medical Branch
Galveston
Texas
77555-0587
United States
ID
Term
D001005
Anus Neoplasms
D002583
Uterine Cervical Neoplasms
D004938
Esophageal Neoplasms
D006258
Head and Neck Neoplasms
D010412
Penile Neoplasms
D014846
Vulvar Neoplasms
D000077195
Squamous Cell Carcinoma of Head and Neck
D018304
Esthesioneuroblastoma, Olfactory
D012468
Salivary Gland Neoplasms
Ancestor Terms
ID
Term
D012004
Rectal Neoplasms
D015179
Colorectal Neoplasms
D007414
Intestinal Neoplasms
D005770
Gastrointestinal Neoplasms
D004067
Digestive System Neoplasms
D009371
Neoplasms by Site
D009369
Neoplasms
D004066
Digestive System Diseases
D005767
Gastrointestinal Diseases
D007410
Intestinal Diseases
D001004
Anus Diseases
D012002
Rectal Diseases
D014594
Uterine Neoplasms
D005833
Genital Neoplasms, Female
D014565
Urogenital Neoplasms
D002577
Uterine Cervical Diseases
D014591
Uterine Diseases
D005831
Genital Diseases, Female
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications