Precancerous ConditionPhase 2NCT00060099
SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia
A Phase 2 study testing HspE7 in people with Precancerous Condition, run by Dana-Farber/Brigham and Women's Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of or treat early cancer. SGN-00101 may be effective in preventing the development of cervical cancer in patients with cervical intraepithelial neoplasia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Precancerous Condition
- What is being tested?
- HspE7
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- May 2003to not given
- Phase
- Phase 2
- 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 confirmed grade II or III cervical intraepithelial neoplasia
- Confirmed by colposcopy-directed punch biopsy
- Accessible, definable, and entirely visible cervical lesions persisting after biopsy
- Satisfactory colposcopic exam within 3-6 weeks after diagnostic biopsy
- Positive for human papilloma virus 16
- CD4+ counts normal
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0
Life expectancy
- Not specified
Hematopoietic
- No coagulation disorder that requires medical intervention
Hepatic
- Hepatitis B core antigen negative
- Hepatitis C antibody negative
Renal
- Not specified
Cardiovascular
- No cardiovascular disorder that requires medical intervention
Pulmonary
- No respiratory disorder that requires medical intervention
Immunologic
- HIV negative
- Not immunologically compromised
- No prior severe allergic reactions (anaphylactic response) to drugs or any other allergen
- No immunological disorders including any of the following:
- Lupus
- Diabetes
- Multiple sclerosis
- Myasthenia gravis
- No active systemic infections that require medical intervention
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Willing to undergo a loop electrosurgical excision procedure
- No medical or psychiatric illness that would preclude study treatment, ability to give informed consent, or study compliance
- No other prior malignancy except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy
- No other concurrent gene therapy
- No concurrent biologic therapy
Chemotherapy
- No concurrent chemotherapy
Endocrine therapy
- More than 30 days since prior systemic steroid therapy
Radiotherapy
- No concurrent radiotherapy
Surgery
- Not specified
Other
- More than 30 days since prior investigational drugs
- No other concurrent investigational drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Phase II Randomized, Double-Blinded Trial Of SGN-00101 (HSP-E7) For Treatment Of CIN II/III
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of or treat early cancer. SGN-00101 may be effective in preventing the development of cervical cancer in patients with cervical intraepithelial neoplasia.
PURPOSE: This randomized phase II trial is studying how well SGN-00101 works in preventing cervical cancer in patients with cervical intraepithelial neoplasia and human papillomavirus.
Read the detailed description
OBJECTIVES:
- Compare the efficacy of SGN-00101 vs placebo in patients with grade II or III cervical intraepithelial neoplasia.
- Correlate clinical response, as defined by histologic demonstration of lesion regression, with potential surrogate markers of vaccine efficacy (e.g., spectroscopic changes in the epithelium, development of human papilloma virus (HPV)-specific mucosal and systemic T-cell responses, and levels of HPV-specific antibody in cervical secretions), in patients treated with this drug.
OUTLINE: This is a randomized, double-blind study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive SGN-00101 subcutaneously (SC) once a month for 3 consecutive months in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive placebo SC as in arm I. Patients are followed monthly for 3 months after the last injection and then undergo large loop excision of the transformation zone under colposcopy at the fourth month. Patients with disease progression undergo immediate large loop excision.
PROJECTED ACCRUAL: A maximum of 80 patients (40 per treatment arm) will be accrued for this study.
- Conditions
- Precancerous Condition
- Being tested
- HspE7
- Keywords
- cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3, human papilloma virus infection
- Medical subject headings
- Precancerous Conditions, Uterine Cervical Dysplasia, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HspE7Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2003 (estimated)
- Study startMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precancerous ConditionStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Dana-Farber/Brigham and Women's Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Kristin A. Keefe, MD, Study chair, Dana-Farber/Brigham and Women's Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00060099
- Sponsor's protocol ID
- CDR0000299462
- Other IDs
- BWH-000-P-CONS01, NCI-3074
- Status last verified
- Mar 2005
- First submitted
- 6 May 2003
- Last updated
- 6 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized, Double-Blinded Trial Of SGN-00101 (HSP-E7) For Treatment Of CIN II/III
- ClinicalTrials.gov ID
- NCT00060099
- Acronym / sponsor ID
- CDR0000299462
- Conditions
- Precancerous Condition
- Keywords
- cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3, human papilloma virus infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Dana-Farber/Brigham and Women's Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2003
- First posted
- 7 May 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: Chemoprevention therapy is the use of certain drugs to try to prevent the development of or treat early cancer. SGN-00101 may be effective in preventing the development of cervical cancer in patients with cervical intraepithelial neoplasia.
PURPOSE: This randomized phase II trial is studying how well SGN-00101 works in preventing cervical cancer in patients with cervical intraepithelial neoplasia and human papillomavirus.
Detailed description
OBJECTIVES:
- Compare the efficacy of SGN-00101 vs placebo in patients with grade II or III cervical intraepithelial neoplasia.
- Correlate clinical response, as defined by histologic demonstration of lesion regression, with potential surrogate markers of vaccine efficacy (e.g., spectroscopic changes in the epithelium, development of human papilloma virus (HPV)-specific mucosal and systemic T-cell responses, and levels of HPV-specific antibody in cervical secretions), in patients treated with this drug.
OUTLINE: This is a randomized, double-blind study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive SGN-00101 subcutaneously (SC) once a month for 3 consecutive months in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive placebo SC as in arm I. Patients are followed monthly for 3 months after the last injection and then undergo large loop excision of the transformation zone under colposcopy at the fourth month. Patients with disease progression undergo immediate large loop excision.
PROJECTED ACCRUAL: A maximum of 80 patients (40 per treatment arm) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
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 |
|---|---|---|
| HspE7 | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2013.
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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.
Kristin A. Keefe, MD study chair
Dana-Farber/Brigham and Women's Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HspE7 in people with Precancerous Condition, run by Dana-Farber/Brigham and Women's Cancer Center at 1 site 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: status not confirmed, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 6 Nov 2013.