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

Phase 1/2 Completed 16 enrolled Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins National Cancer Institute (NCI) · collab

Non-randomizedSingle-groupOpen-labelPrevention

Summary

RATIONALE: Vaccines made from protein and DNA may help the body build an effective immune response to kill abnormal cells in the cervix. The use of vaccine therapy may prevent cervical cancer. PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy and to see how well it works in preventing cervical cancer in patients with cervical intraepithelial neoplasia and human papillomavirus.

Timeline

Start: 2003-11
Primary completion: 2010-01
Completion: 2010-01

Publications

Results Trimble CL, Peng S, Kos F, Gravitt P, Viscidi R, Sugar E, Pardoll D, Wu TC. A phase I trial of a human papillomavirus DNA vaccine for HPV16+ cervical intraepithelial neoplasia 2/3. Clin Cancer Res. 2009 Jan 1;15(1):361-7. doi: 10.1158/1078-0432.CCR-08-1725.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	pNGVL4a-Sig/E7(detox)/HSP70	Vaccine	0.5 mg	Intramuscular
Subject	pNGVL4a-Sig/E7(detox)/HSP70	Vaccine	1 mg	Intramuscular
Subject	pNGVL4a-Sig/E7(detox)/HSP70	Vaccine	3 mg	Intramuscular

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

Summary

Timeline

Publications

Drugs

Indications