Phase I Trial of Intratumoral Administration of HF10, A Replication Competent Herpes Simplex Virus Type 1, in Patients With Refractory Head and Neck Cancer or Solid Tumors With Cutaneous and/or Superficial Lesions
This is an open label, non-randomized, multicenter, two-stage, dose escalation Phase I study
evaluating single and repeated intratumoral injections of the oncolytic virus, HF10, in
patients with refractory head and neck cancer, or solid tumors with cutaneous and/or
superficial lesions (e.g., squamous cell carcinoma of the skin, carcinoma of the breast, and
malignant melanoma).
Stage 1: Stage 1 of the study will investigate dose escalation of a single intratumoral
injection over the following dose levels: 1 x 10^5 TCID50, 3 x 10^5 TCID50, 1 x 10^6 TCID50,
and 1 x 10^7 TCID50. In Stage 1, it is planned that 3 patients will be enrolled per single
dose cohort. Within each single dose cohort, accrual will temporarily be suspended after the
first patient is entered and the patient will be followed for safety and for viral
distribution and elimination. The patients in Stage 1 must be seropositive for HSV-1.
Stage 2: Stage 2 will evaluate repeated intratumoral injections of HF10 at dose levels of 1
x 10^6 TCID50/dose and 1 x 10^7 TCID50/dose. Three patients will be enrolled in each of the
repeated dose cohorts. In Stage 2, the first patient treated in each repeated dose cohort
must be seropositive for HSV-1. Patients in the repeated dose cohort will receive a total of
four intratumoral injections in the same lesion.
Following completion of dosing in the repeated dose cohorts, an expansion cohort of three
additional patients will be treated at the highest tolerated dose level.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assessment of the local tumor response of the HF10-injected tumor by a modified target Response Evaluation Criteria In Solid Tumors (RECIST) method
one year
Yes
Robert L Ferris, MD, PhD
Principal Investigator
Division of Head and Neck Cancer Surgery, University of Pittsburgh Cancer Institute
United States: Food and Drug Administration
M06-10083
NCT01017185
August 2009
March 2014
Name | Location |
---|---|
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
Montefiore Medical Center | Bronx, New York 10467-2490 |
University of Pittsburgh | Pittsburgh, Pennsylvania 15261 |
Oregon Health and Science University | Portland, Oregon 97201 |
Mary Crowley Cancer Research Center | Dallas, Texas 75246 |