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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Montefiore Medical Center
The Bronx, New York, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Mary Crowley Cancer Research Center
Dallas, Texas, United States
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
Adverse events, vital signs, electrocardiogram(ECG), clinical laboratory tests, and physical exercise
Time frame: one year
Histological tumor response by biopsy
Time frame: one year
Overall tumor response of the HF10-injected tumor plus additional non-injected target tumors.
Time frame: one year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Huntsman Cancer Institute
Salt Lake City, Utah, United States