Clinical trial · Interventional
Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia
Phase II Evaluation Of SGN-00101 (HSP-E7) Fusion Protein In Women With Cervical Intraepithelial Neoplasia 3, CIN 3
NCT00054041CI-TRIAL-00009079completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Intraepithelial Neoplasia Grade 3 | — | UNRESOLVED | — |
| Human Papilloma Virus Infection | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HspE7 | Biological | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (HspE7)
- description
- 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.
- interventionNames
- Biological: HspE7
- Procedure: therapeutic conventional surgery
- Other: laboratory biomarker analysis
- type
- EXPERIMENTAL
- label
- Arm II (control)
- description
- Patients receive standard care. At week 15, all patients undergo large loop excision of the transformation zone under colposcopy.
- interventionNames
- Procedure: therapeutic conventional surgery
- Other: laboratory biomarker analysis
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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
References
Publications (1)
- DERIVEDRoy 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. PMID 40313865