Cervical CancerPhase 2NCT00054041
Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia
A Phase 2 study testing HspE7, therapeutic conventional surgery and laboratory biomarker analysis in people with Cervical Cancer and Cervical Intraepithelial Neoplasia Grade 3, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Vaccines made from antigens may make the body build an immune response to kill abnormal cervical cells and may be effective in preventing cervical cancer. Randomized phase II trial to study the effectiveness of vaccine therapy in preventing cervical cancer in patients who have cervical intraepithelial neoplasia Read more about this study
- Who is it for?
- Ages 17 years and older, women only
- Conditions the study is for
- Cervical Cancer, Cervical Intraepithelial Neoplasia Grade 3, Human Papilloma Virus Infection
- What is being tested?
- HspE7, therapeutic conventional surgery and laboratory biomarker analysis
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Jan 2007
- 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 17 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed grade III cervical intraepithelial neoplasia
- Confirmed by biopsy or colposcopy
- Positive for human papilloma virus 16
- No endocervical glandular dysplasia
- No adenocarcinoma in situ
- Performance status - GOG 0-2
Show all 26Show fewer
- No life-threatening or serious hematological disorder
- No life-threatening or serious hepatic disorder
- No life-threatening or serious renal disorder
- No life-threatening or serious cardiac disorder
- No life-threatening or serious respiratory disorder
- HIV negative
- Must be immunocompetent
- No history of autoimmune disease
- No life-threatening or serious immunological disorder
- No prior or concurrent severe allergic disease
- No concurrent human papilloma viral infection other than type 16
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No life-threatening or serious gastrointestinal disorder
- No life-threatening or serious endocrine disorder
- No invasive malignancy within the past 5 years except nonmelanoma skin cancer
- No concurrent chronic or systemic steroids
- No prior organ transplantation
- No prior cancer therapy that would preclude study therapy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gynecologic Oncology Group
Philadelphia, Pennsylvania, 19103
About this study
Official title: Phase II Evaluation Of SGN-00101 (HSP-E7) Fusion Protein In Women With Cervical Intraepithelial Neoplasia 3, CIN 3
Vaccines made from antigens may make the body build an immune response to kill abnormal cervical cells and may be effective in preventing cervical cancer. Randomized phase II trial to study the effectiveness of vaccine therapy in preventing cervical cancer in patients who have cervical intraepithelial neoplasia
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the efficacy of SGN-00101, in terms of complete histologic regression, in patients with grade III cervical intraepithelial neoplasia.
II. Determine the toxicity of this drug in these patients.
SECONDARY OBJECTIVES:
- Determine change in lesion size in these patients after treatment with this drug.
II. Compare histologic response before and after treatment with this drug in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive SGN-00101 subcutaneously once on weeks 1, 4, and 8 in the absence of disease progression.
Arm II: Patients receive standard care.
At week 15, all patients undergo large loop excision of the transformation zone under colposcopy.
Patients are followed at 19 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 28-84 patients (14-42 per treatment arm) will be accrued for this study within 12-48 months.
- Conditions
- Cervical Cancer, Cervical Intraepithelial Neoplasia Grade 3, Human Papilloma Virus Infection
- Being tested
- HspE7, therapeutic conventional surgery, laboratory biomarker analysis
- Medical subject headings
- Uterine Cervical Neoplasms, 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
Also called HPV 16 E7/HSP65 Vaccine, HPV E7 Peptide Epitope Vaccine, SGN-00101
Given subcutaneously
therapeutic conventional surgeryProcedure or surgery
Undergo large loop excision
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (HspE7) | Experimental | Patients receive SGN-00101 subcutaneously once on weeks 1, 4, and 8 in the absence of disease progression. At week 15, all patients undergo large loop excision of the transformation zone under colposcopy. Receives: Biological: HspE7; Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis |
| Arm II (control) | Experimental | Patients receive standard care. At week 15, all patients undergo large loop excision of the transformation zone under colposcopy. Receives: Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete histologic regression of all CIN 3 lesions
Fisher's exact test (and if feasible, Chi-Square test) will be conducted to see if the probability of responding in the investigational arm is significantly different from the controls actively accrued to this study. The conditional distribution used in Fisher's exact test will be used to calculate a 90% confidence interval for the odds ratio of observing a response in the investigational arm to the control arm.
Measured: Up to 3 years
Frequency and severity of adverse events assessed by Common Toxicity Criteria (CTC) version 2.0
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2003 (estimated)
- Study startJun 2004
- Primary completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Cornelia Trimble, Principal investigator, Gynecologic Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00054041
- Sponsor's protocol ID
- NCI-2012-02513
- Other IDs
- GOG-0197, U10CA027469, CDR0000269709
- Status last verified
- Jan 2013
- First submitted
- 5 Feb 2003
- Last updated
- 24 Jan 2013
- Results posted
- No
Publications
Roy AA, Pandey A, Dhas N, Hegde MM, Parekh HS, Andugulapati SB, Nandakumar K, Satish Rao BS, Mutalik S. The Confluence of Nanotechnology and Heat Shock Protein 70 in Pioneering Glioblastoma Multiforme Therapy: Forging Pathways Towards Precision Targeting and Transformation. Adv Pharmacol Pharm Sci. 2025 Apr 24;2025:1847197. doi: 10.1155/adpp/1847197. eCollection 2025.
PubMed 40313865
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Evaluation Of SGN-00101 (HSP-E7) Fusion Protein In Women With Cervical Intraepithelial Neoplasia 3, CIN 3
- ClinicalTrials.gov ID
- NCT00054041
- Acronym / sponsor ID
- NCI-2012-02513
- Conditions
- Cervical Cancer, Cervical Intraepithelial Neoplasia Grade 3, Human Papilloma Virus Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jun 2004
- Primary completion
- Jan 2007 (actual)
- First posted
- 6 Feb 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.
Vaccines made from antigens may make the body build an immune response to kill abnormal cervical cells and may be effective in preventing cervical cancer. Randomized phase II trial to study the effectiveness of vaccine therapy in preventing cervical cancer in patients who have cervical intraepithelial neoplasia
Detailed description
PRIMARY OBJECTIVES:
- Determine the efficacy of SGN-00101, in terms of complete histologic regression, in patients with grade III cervical intraepithelial neoplasia.
II. Determine the toxicity of this drug in these patients.
SECONDARY OBJECTIVES:
- Determine change in lesion size in these patients after treatment with this drug.
II. Compare histologic response before and after treatment with this drug in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive SGN-00101 subcutaneously once on weeks 1, 4, and 8 in the absence of disease progression.
Arm II: Patients receive standard care.
At week 15, all patients undergo large loop excision of the transformation zone under colposcopy.
Patients are followed at 19 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 28-84 patients (14-42 per treatment arm) will be accrued for this study within 12-48 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (HspE7) | Experimental | Biological: HspE7, Procedure: therapeutic conventional surgery, Other: laboratory biomarker analysisPatients receive SGN-00101 subcutaneously once on weeks 1, 4, and 8 in the absence of disease progression. At week 15, all patients undergo large loop excision of the transformation zone under colposcopy. |
| Arm II (control) | Experimental | Procedure: therapeutic conventional surgery, Other: laboratory biomarker analysisPatients receive standard care. At week 15, all patients undergo large loop excision of the transformation zone under colposcopy. |
Who may qualify
- Ages
- 17 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (26 listed)
- Histologically confirmed grade III cervical intraepithelial neoplasia
- Positive for human papilloma virus 16
- No endocervical glandular dysplasia
- No adenocarcinoma in situ
- Performance status - GOG 0-2
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| HspE7Also: HPV 16 E7/HSP65 Vaccine, HPV E7 Peptide Epitope Vaccine, SGN-00101Given subcutaneously | Biological | Arm I (HspE7) |
| therapeutic conventional surgeryUndergo large loop excision | Procedure or surgery | Arm I (HspE7), Arm II (control) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (HspE7), Arm II (control) |
Primary outcome
Complete histologic regression of all CIN 3 lesions
Time frame: Up to 3 years
Fisher's exact test (and if feasible, Chi-Square test) will be conducted to see if the probability of responding in the investigational arm is significantly different from the controls actively accrued to this study. The conditional distribution used in Fisher's exact test will be used to calculate a 90% confidence interval for the odds ratio of observing a response in the investigational arm to the control arm.
Frequency and severity of adverse events assessed by Common Toxicity Criteria (CTC) version 2.0
Time frame: Up to 3 years
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 24 Jan 2013.
- Derived from this study: PubMed 40313865Roy AA, Pandey A, Dhas N, Hegde MM, Parekh HS, Andugulapati SB, Nandakumar K, Satish Rao BS, Mutalik S. The Confluence of Nanotechnology and Heat Shock Protein 70 in Pioneering Glioblastoma Multiforme Therapy: Forging Pathways Towards Precision Targeting and Transformation. Adv Pharmacol Pharm Sci. 2025 Apr 24;2025:1847197. doi: 10.1155/adpp/1847197. eCollection 2025.
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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.
Cornelia Trimble principal investigator
Gynecologic Oncology Group
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, therapeutic conventional surgery and laboratory biomarker analysis in people with Cervical Cancer and Cervical Intraepithelial Neoplasia Grade 3, run by National Cancer Institute (NCI) 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?
The sponsor lists 26 inclusion and 0 exclusion criteria. 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 24 Jan 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?
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.
What does the primary outcome measure?
Complete histologic regression of all CIN 3 lesions (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00054041, which also lists 1 linked publication.
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 24 Jan 2013.