Study of HF10 in Patients With Refractory Head and Neck Cancer or Solid Tumors With Cutaneous and/or Superficial Lesions

Phase 1

Completed

• Conditions: Squamous Cell Carcinoma, Skin; Carcinoma of the Breast; Malignant Melanoma; Refractory Head and Neck Cancer
• Interventions: Drug: HF10

• Registration Number: NCT01017185
• Lead Sponsor: Takara Bio Inc.

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-11-18
• Study First Submitted QC: 2009-11-19
• Study First Posted: 2009-11-20
• Primary Completion: 2014-05
• Study Completion: 2015-03
• Status Verified: 2015-05
• Last Update Submitted: 2019-05-21
• Last Update Posted: 2019-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oncolytic virotherapy, intratumoral injection of HF10	HF10	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Adverse events, vital signs, electrocardiogram(ECG), clinical laboratory tests, and physical exercise	one year
Histological tumor response by biopsy	one year
Overall tumor response of the HF10-injected tumor plus additional non-injected target tumors.	one year

Trial Locations

Locations (5)

Mary Crowley Cancer Research Center; 🇺🇸 Dallas, Texas, United States

Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States