Study of HF10 in Patients With Refractory Head and Neck Cancer or Solid Tumors With Cutaneous and/or Superficial Lesions
The purpose of this study is to determine whether HF10 is safe and effective in the treatment of head and neck cancer or solid tumors with cutaneous and/or superficial lesions.
Refractory Head and Neck Cancer
Squamous Cell Carcinoma, Skin
Carcinoma of the Breast
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Assessment of the local tumor response of the HF10-injected tumor by a modified target Response Evaluation Criteria In Solid Tumors (RECIST) method [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- Adverse events, vital signs, electrocardiogram(ECG), clinical laboratory tests, and physical exercise [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- Histological tumor response by biopsy [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- Overall tumor response of the HF10-injected tumor plus additional non-injected target tumors. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2009|
|Study Completion Date:||March 2015|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
|Experimental: Oncolytic virotherapy, intratumoral injection of HF10||Drug: HF10|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01017185
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10461-2374|
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Texas|
|Mary Crowley Cancer Research Center|
|Dallas, Texas, United States, 75230|
|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake, Utah, United States, 84112|
|Principal Investigator:||Robert L Ferris, MD, PhD||Division of Head and Neck Cancer Surgery, University of Pittsburgh Cancer Institute|