Who is sponsoring NCT00121173?

NCT00121173 is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

What condition does NCT00121173 study?

NCT00121173 studies Cervical Cancer, Precancerous Condition.

What drugs are being tested in NCT00121173?

Interventions: pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine.

What is the status of NCT00121173?

NCT00121173 is currently COMPLETED.

Last reviewed 2018-06-20 · How we verify

A Phase I/II Clinical Trial of pNGVL4a-Sig/E7 (Detox)/HSP70 for the Treatment of Patients With HPV 16+ Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)

NCT00121173 Phase 1/Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	16
Start date	2003-11
Completion	2010-01

Conditions

Cervical Cancer
Precancerous Condition

Interventions

pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine

Primary outcomes

Safety and Toxicity — for the duration of the study, and whenever possible, for an additional 5 years
Number of participants with serious adverse events (SAE) according to CTCAE 3.0 grading.
Efficacy — for the duration of the study, and whenever possible, for an additional 5 years
The efficacy of pNGVL4a-SigE7(detox)HSP70 DNA vaccine, administered intra-muscularly. This is reported as number of participants with histologic regression of CIN2/3 to CIN1 or less by colposcopically-directed biopsy.

Countries

United States