GOG-0265

A Phase II Evaluation of ADXS11-001 (NSC 752718, BB-IND#13,712) in the Treatment of Persistent or Recurrent Squamous or Non-Squamous Cell Carcinoma of the Cervix

Principal Investigator

Warner Huh, MD

Status

Disease Site

Gynecologic [GY] Cervix

Phase

II

Developmental Therapeutics

No

Primary Objective

To evaluate the tolerability, safety and nature and degree of toxicity of ADXS11-001 by the numbers of patients with dose limiting toxicities (DLTs) and adverse events as assessed by the CTCAE v4.0.

To assess the activity of ADXS11-001 for patients with persistent or recurrent carcinoma of the cervix with the frequency of patients who survive for at least 12 months after initiating therapy.

Patient Population

To evaluate the tolerability, safety and nature and degree of toxicity of ADXS11-001 by the numbers of patients with dose limiting toxicities (DLTs) and adverse events as assessed by the CTCAE v4.0.

To assess the activity of ADXS11-001 for patients with persistent or recurrent carcinoma of the cervix with the frequency of patients who survive for at least 12 months after initiating therapy.

Target Accrual

63