IRB #

IRB00005265

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

Principal Investigator

Neil Gross

Study Purpose

The purpose of this study is to see what effects the study drug, HF10, has on patients with head and neck cancer, skin cancer, breast cancer or malignant melanoma that has not responded to standard treatment. The study drug is a live virus similar to Herpes Simplex Virus Type 1 (HSV-1). It will be administered by an injection directly into the tumor.

Medical Condition(s)

Head and neck cancer.
Squamous cell carcinoma of the head and neck.
Skin Cancer.
Breast Cancer.
Malignant Melanoma.

Eligibility Criteria

Adults with head and neck cancer or a tumor on or near the skin surface from another cancer such as skin cancer, breast cancer or malignant melanoma. Patients must have already received prior standard therapy for their cancer.
Other eligibility criteria will apply.

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Patients will receive up to four injections of the study drug directly into their tumor. They will be in the treatment portion of the study for up to 78 days then followed closely for side effects for about 4 weeks. Patients will return for follow-up appointments every 2 months for the first 6 months, every 6 months for the next 2 years, and annually thereafter.

Minors Included

No

Contact

Will Stott, phone 503-418-9235 or e-mail stottw@ohsu.edu

Sponsor

Takara Bio, Inc.

Recruitment End

01/01/2015

Compensation Provided

Yes

Compensation

Some expenses for mileage and hotel stay may be provided by the study sponsor for research-related visits.