Clinical trial · Interventional
SGN-00101 Immunotherapy in Treating Patients With Grade III Cervical Intraepithelial Neoplasia
SGN-00101 (HspE7) Immunotherapy Of CIN III
NCT00075569CI-TRIAL-00033032completedPhase 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 cancer or to treat early cancer. SGN-00101 may be effective in preventing the development of cervical cancer in patients who have cervical intraepithelial neoplasia. PURPOSE: This phase II trial is studying how well SGN-00101 immunotherapy works in preventing cervical cancer in patients with grade III cervical intraepithelial neoplasia.
Conditions
Conditions (2)
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 |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HspE7 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1 month follow-up
- description
- 3 monthly subcutaneous vaccinations with 500 microg of HspE7 followed by monthly colposcopic follow-up for 1 month; followed by LEEP or cone biopsy
- interventionNames
- Biological: HspE7
- type
- ACTIVE_COMPARATOR
- label
- 2 month follow-up
- description
- 3 monthly subcutaneous vaccinations with 500 microg of HspE7 followed by monthly colposcopic follow-up for 2 months; followed by LEEP or cone biopsy
- interventionNames
- Biological: HspE7
Primary outcomes (2)
- measure
- Rate of regression
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed grade III cervical intraepithelial neoplasia (CIN III) with colposcopically visible cervical lesions * No positive endocervical curettage or inadequate colposcopy at the time of initial cervical biopsy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Not specified Life expectancy * Not specified Hematopoietic * WBC at least 3,500/mm\^3 * Lymphocyte count at least 500/mm\^3 * Platelet count at least 150,000/mm\^3 * Hemoglobin at least 10 g/dL * No significant hematologic disease that is uncontrolled with standard therapy Hepatic * Bilirubin no greater than 2 mg/dL * Liver enzymes no greater than 2.5 times normal * No significant hepatic disease that is uncontrolled with standard therapy Renal * Creatinine no greater than 2 mg/dL * No significant renal disease that is uncontrolled with standard therapy Cardiovascular * No significant cardiovascular disease that is uncontrolled with standard therapy Pulmonary * No significant respiratory disease that is uncontrolled with standard therapy * No history of asthma Immunologic * HIV negative * No clinical evidence of immunosuppression * No autoimmune disease * No history of allergic reactions attributed to compounds of similar chemical or biological activity as those used in this study * No history of a positive purified protein derivative (PPD) or Tine test Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Good health based upon the results of a medical history, physical examination, vital signs, and laboratory profile * No uncontrolled chronic disease * Chronic disease requiring medication is allowed provided the patient is not taking immunosuppressive drugs * No significant endocrine (e.g., thyroid or diabetes), neurologic, gastrointestinal, or dermatologic disease that is uncontrolled with standard therapy * No other underlying or unstable disease that would be exacerbated by the study treatment PRIOR CONCURRENT THERAPY: Biologic therapy * No prior BCG vaccination * No other concurrent vaccine therapy Chemotherapy * No concurrent chemotherapy Endocrine therapy * More than 30 days since prior oral or parenteral glucocorticoid steroid Radiotherapy * Not specified Surgery * Not specified Other * More than 30 days since prior participation in another investigational study * No concurrent cytotoxic therapy * No other concurrent investigational agents * No other concurrent investigational or commercial agents or therapies intended to treat CIN
References
Publications (1)
- RESULTEinstein MH, Kadish AS, Burk RD, Kim MY, Wadler S, Streicher H, Goldberg GL, Runowicz CD. Heat shock fusion protein-based immunotherapy for treatment of cervical intraepithelial neoplasia III. Gynecol Oncol. 2007 Sep;106(3):453-60. doi: 10.1016/j.ygyno.2007.04.038. Epub 2007 Jun 22. PMID 17586030