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

NCT01017185 | Completed Phase 1

• 1 other identifier: M06-10083
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 5

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.

Conditions

Refractory Head and Neck Cancer; Squamous Cell Carcinoma, Skin; Carcinoma of the Breast; Malignant Melanoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

Oncolytic virotherapy, intratumoral injection of HF10

EXPERIMENTAL

Drug: HF10

Interventions

HF10 DRUG

Oncolytic virotherapy, intratumoral injection of HF10

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically confirmed solid tumors that have failed standard therapies (surgery, chemotherapy, radiotherapy, or endocrine therapy) and for which no curative options exist, including, but not limited to:
• Squamous cell carcinoma of the head and neck
• Squamous cell carcinoma of the skin
• Carcinoma of the breast
• Malignant melanoma
• Patients may have had any kind and number of prior cancer therapies.
• Patients must have measurable non-visceral lesions that are evaluable by the RECIST method
• The tumor mass to be treated must be non-visceral and adequate for injection (i.e., more than 2 cm away from major vascular structures) and measurement by RECIST.
• Patients in Stage 1 must be seropositive for HSV-1.
• The first patient enrolled into each cohort in Stage 2 must be seropositive for HSV-1.
• Patients must be ≥ 18 years of age.
• Patients must have a life expectancy ≥ 12 weeks
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• Patients must have adequate hepatic function, as defined as
• Total bilirubin levels ≤ 1.5 x upper limit of normal (ULN)

You may not qualify if:

• Patients receiving chemotherapy or radiotherapy within 4 weeks of injection of HF10, or adverse events \> Grade 1, except alopecia, resulting from agents administered more than 4 weeks prior to HF10 injection.
• Patients with a history of significant tumor bleeding, or coagulation or bleeding disorders.
• Patients with nasopharyngeal tumors.
• Patients with deep (below the platysma muscle layer) ulcerative tumors.
• Patients with target tumors that could potentially invade a major vascular structure(s) (e.g., innominate artery, carotid artery), based on unequivocal imaging findings, as determined by a radiologist.
• Patients with Grade ≥ 1 pre-existing neurologic abnormalities (CTCAE version 3.0).
• Patients who have been hospitalized for emergent conditions requiring inpatient evaluation, treatment or procedure during the 30 days prior to entry on study. In addition, emergent conditions requiring inpatient evaluation, treatment or procedure must have resolved or be medically stable and not severe for 30 days prior to entry on study.
• Patients with clinically evident Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C virus (HCV), or Epstein-Barr virus (EBV) infection. Patients will be tested for HIV during pre-treatment screening.
• Patients receiving steroids or immunosuppressive agents, e.g., for rheumatoid arthritis
• Concurrent use of any other investigational agents.
• Presence or history of central nervous system metastasis.
• Pregnant or breastfeeding women;women desiring to become pregnant within the timeframe of the study are also excluded.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• Takara Bio Inc.: lead

Study Sites (5)

Montefiore Medical Center

The Bronx, New York, 10461-2374, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Mary Crowley Cancer Research Center

Dallas, Texas, 75230, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma, Squamous Cell; Breast Neoplasms; Melanoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms

Study Officials

• Robert L Ferris, MD, PhD

  Division of Head and Neck Cancer Surgery, University of Pittsburgh Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: November 20, 2009
• Study Start: August 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: March 1, 2015
• Last Updated: May 23, 2019

Record last verified: 2015-05

Locations

US (5)