Vaccine Therapy With or Without Imiquimod in Treating Patients With Grade 3 Cervical Intraepithelial Neoplasia

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Vaccines made from DNA or a gene-modified virus may help the body build an effective immune response to kill tumor cells. Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Applying topical imiquimod to the cervix may be an effective treatment for cervical intraepithelial neoplasia. Giving vaccine therapy together with imiquimod may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy and to see how well it works when given with or without imiquimod in treating patients with grade 3 cervical intraepithelial neoplasia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Imiquimod; Vaccines

Criteria

DISEASE CHARACTERISTICS:

• Colposcopically and biopsy confirmed grade 3 cervical intraepithelial neoplasia

• Human papillomavirus (HPV) 16-positive disease by PCR

• Measurable disease after diagnostic biopsy

• No concurrent adenocarcinoma in situ of the cervix

PATIENT CHARACTERISTICS:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use an effective form of contraception during study treatment

• Immunocompetent

• No concurrent malignancy, except for nonmelanoma skin lesions

• No serious concurrent disorder, including any of the following:

• Active systemic infection

• Autoimmune disease

• Proven or suspected immunosuppressive disorder

• Major medical illnesses of the cardiovascular or respiratory system

• No evidence or history of cardiac disease, including any of the following:

• Congestive heart failure

• Symptomatic arrhythmia not controlled by medication

• Unstable angina

• History of acute myocardial infarction or cerebrovascular accident within the past 6 months

• No history of severe allergy including eczema or other exfoliative skin disorder

• No active eczema within the past 12 months

• No concurrent skin conditions, including any of the following:

• Burns

• Traumatic or pruritic skin conditions

• Open wounds

• Unhealed surgical scars

• Patients and their close social, sexual, or domestic contacts may not have any of the following active skin diseases:

• Psoriasis

• Lichen planus

• Sever acneiform rash

• Impetigo

• Varicella zoster

• Sepsis

• No close social contact with children under 5 years old

• No close social or domestic contact with a pregnant woman

• No HIV seropositivity

• No allergy to eggs

PRIOR CONCURRENT THERAPY:

• No previous vaccination with vaccinia

• No immunosuppressive medication (i.e., steroid therapy or other immunosuppressive/immunomodulating drugs [e.g., cyclosporine]) within the past 2 months

• No investigational agent(s) within the past 6 months

• No concurrent participation in another experimental protocol