Clinical trial · Interventional
Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer
A Phase II Trial in Patients With Early Cervical Cancer to Study The Safety and The Immunological Effects of Vaccination With TA-HPV, A Live Recombinant Vaccinia Virus Expressing The Human Papilloma Virus 16 and 18 E6 and E7 Proteins
- 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: Vaccines made from human papillomavirus may make the body build an immune response to and kill cervical cancer cells. Combining vaccine therapy with surgery may be a more effective treatment for cervical cancer. PURPOSE: This phase II trial is studying how well giving vaccine therapy together with surgery works in treating patients with early cervical cancer.
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 |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| human papillomavirus 16 E7 peptide | Biological | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| surgical procedure | Procedure | — | UNRESOLVED |
| synthetic human papillomavirus 16 E6 peptide | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Immunological response to HPV
- measure
- Toxicity and safety of TA-HPV
Secondary outcomes (2)
- measure
- Proliferative capacity of T-cells to the E6 and E7 proteins
- measure
- Influence of vaccination with TA-HPV on the disease free interval or patterns of recurrence
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven untreated stage Ib or IIa cervical carcinoma, squamous or adenocarcinoma suitable for surgical excision * No CNS metastases * Circulating CD4+ lymphocyte count at least 400 * Proven absence of hepatitis B and C antibodies * Previous exposure to vaccinia from smallpox vaccination, as well as no previous exposure, is allowed * Reaction to 2 or more antigens on Pasteur Merieux CMI test required * Ability to collaborate planned follow-up required PATIENT CHARACTERISTICS: Age: * 19 and over Performance status: * WHO/ECOG no greater than 2 Life expectancy: * At least 3 months Hematopoietic: * WBC greater than 3,000 (3,000 x 10 to the ninth/L) * Platelet count greater than 120,000 (120 x 10 to the ninth/L) * No bleeding disorder Hepatic: * Bilirubin less than 1.5 times normal * AST and ALT less than 1.5 times normal * Prothrombin or partial thromboplastin time no greater than 2 times normal Renal: * Creatinine less than 1.3 mg/dL (120 micromoles/L) Other: * No ongoing infection * No HIV antibody * No serious medical or psychiatric illness * No second malignancy within 5 years except for curatively treated basal cell skin cancer which required surgery, hormone therapy, immunotherapy or chemotherapy * Not pregnant or nursing * Adequate contraception required * Patient or her household contacts must not have any of the following: * Chronic steroid therapy * Renal or other allograft * Known immunodeficiency * Eczema * Children under 5 years old PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified
References
Publications (0)
Data not yet available