Malignant Melanoma Clinical Trial
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
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.
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