Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia

Completed · Phase 2

Conditions studied: Cervical Cancer, Cervical Intraepithelial Neoplasia Grade 3, Human Papilloma Virus Infection

In brief

Vaccines made from antigens may make the body build an immune response to kill abnormal cervical cells and may be effective in preventing cervical cancer. Randomized phase II trial to study the effectiveness of vaccine therapy in preventing cervical cancer in patients who have cervical intraepithelial neoplasia

Key facts

Study ID

NCT00054041

Run by

National Cancer Institute (NCI)

People needed

84

Starts

2004-06-01

Last updated by the study team

2013-01-24

Who can join

Age: 17 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed grade III cervical intraepithelial neoplasia
• Confirmed by biopsy or colposcopy
• Positive for human papilloma virus 16
• No endocervical glandular dysplasia
• No adenocarcinoma in situ
• Performance status - GOG 0-2
• No life-threatening or serious hematological disorder
• No life-threatening or serious hepatic disorder
• No life-threatening or serious renal disorder
• No life-threatening or serious cardiac disorder
• No life-threatening or serious respiratory disorder
• HIV negative
• Must be immunocompetent
• No history of autoimmune disease
• No life-threatening or serious immunological disorder
• No prior or concurrent severe allergic disease
• No concurrent human papilloma viral infection other than type 16
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No life-threatening or serious gastrointestinal disorder
• No life-threatening or serious endocrine disorder
• No invasive malignancy within the past 5 years except nonmelanoma skin cancer
• No concurrent chronic or systemic steroids
• No prior organ transplantation

Where it is running

• Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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