Status:
COMPLETED
Vaccine Therapy With or Without Imiquimod in Treating Patients With Grade 3 Cervical Intraepithelial Neoplasia
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cervical Cancer
Precancerous Condition
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief 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 s...
Detailed Description
OBJECTIVES: Primary * To evaluate safety, tolerability, and feasibility of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine and TA-HPV vaccine with or without imiquimod in patients with human papillomavirus ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2023
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00788164
Start Date
November 1 2008
End Date
August 1 2023
Last Update
August 31 2023
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410