Clinical trial · Interventional
SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia
Phase II Randomized, Double-Blinded Trial Of SGN-00101 (HSP-E7) For Treatment Of CIN II/III
NCT00060099CI-TRIAL-00012535unknownPhase 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)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HspE7 | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.