Vaccine Therapy With or Without Imiquimod in Treating Patients With Grade 3 Cervical Intraepithel… (NCT00788164) | Clinical Trial Compass
CompletedPhase 1
Vaccine Therapy With or Without Imiquimod in Treating Patients With Grade 3 Cervical Intraepithelial Neoplasia
United States75 participantsStarted 2008-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ras…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and tolerability as determined by number of participants with Serious Adverse Events
Timeframe: 10 weeks from the first intervention
Trial details
NCT IDNCT00788164
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins