Anal CancerPhase 1NCT00019110
Vaccine Therapy in Treating Patients With Advanced or Recurrent Cancer
A Phase 1 study testing human papillomavirus 16 E7 peptide and synthetic human papillomavirus 16 E6 peptide in people with Anal Cancer and Cervical Cancer, run by National Cancer Institute (NCI) at 6 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anal Cancer, Cervical Cancer, Esophageal Cancer
- What is being tested?
- human papillomavirus 16 E7 peptide and synthetic human papillomavirus 16 E6 peptide
- How many people
- Not given
- Where
- 6 sitesUnited States
- Study dates
- Nov 1995to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
Center for Cancer Research
Bethesda, Maryland, 20892
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114-2617
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Texas Medical Branch
Galveston, Texas, 77555-0587
Morristown Memorial Hospital
Morristown, New Jersey, 07962-1956
About this study
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
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.
Read the 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
- Anal Cancer, Cervical Cancer, Esophageal Cancer, Head and Neck Cancer, Penile Cancer, Vulvar Cancer
- Being tested
- human papillomavirus 16 E7 peptide, synthetic human papillomavirus 16 E6 peptide
- 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, stage III squamous cell carcinoma of the lip and oral cavity
- Medical subject headings
- Anus Neoplasms, Uterine Cervical Neoplasms, Esophageal Neoplasms, Head and Neck Neoplasms, Penile Neoplasms, Vulvar Neoplasms, Squamous Cell Carcinoma of Head and Neck, Esthesioneuroblastoma, Olfactory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human papillomavirus 16 E7 peptideBiological
synthetic human papillomavirus 16 E6 peptideBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startNov 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Barry L. Gause, MD, Study chair, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00019110
- Sponsor's protocol ID
- CDR0000064330
- Other IDs
- NCI-95-C-0154, NCI-T94-0134N
- Status last verified
- Nov 1999
- First submitted
- 11 Jul 2001
- Last updated
- 29 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00019110
- Acronym / sponsor ID
- CDR0000064330
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Nov 1995
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| human papillomavirus 16 E7 peptide | Biological | – |
| synthetic human papillomavirus 16 E6 peptide | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry L. Gause, MD study chair
National Cancer Institute (NCI)
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing human papillomavirus 16 E7 peptide and synthetic human papillomavirus 16 E6 peptide in people with Anal Cancer and Cervical Cancer, run by National Cancer Institute (NCI) at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2015.