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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01017185
Recruitment Status : Completed
First Posted : November 20, 2009
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Takara Bio Inc.

Tracking Information
First Submitted Date  ICMJE November 18, 2009
First Posted Date  ICMJE November 20, 2009
Last Update Posted Date May 23, 2019
Study Start Date  ICMJE August 2009
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2012)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 19, 2009)
  • 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 ]
  • Histological tumor response by biopsy [ Time Frame: one year ]
  • Adverse events, vital signs, electrocardiogram (ECG), clinical laboratory tests, and physical exercise [ Time Frame: one year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2009)
Overall tumor response of the HF10-injected tumor plus additional non-injected target tumors [ Time Frame: one year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of HF10 in Patients With Refractory Head and Neck Cancer or Solid Tumors With Cutaneous and/or Superficial Lesions
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Refractory Head and Neck Cancer
  • Squamous Cell Carcinoma, Skin
  • Carcinoma of the Breast
  • Malignant Melanoma
Intervention  ICMJE Drug: HF10
Study Arms  ICMJE Experimental: Oncolytic virotherapy, intratumoral injection of HF10
Intervention: Drug: HF10
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 11, 2015)
28
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2009)
18
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • 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)
    • AST/ALT levels ≤ 2.5 x ULN, or ≤ 5 x ULN if liver metastases are present
  • Patients must have adequate renal function as defined as serum creatinine ≤ 1.5 x ULN or creatinine clearance (calculated) ≥ 60 mL/min/1.73 m2 for patients with creatinine > 1.5 x ULN
  • Patients must have adequate bone marrow function, as defined as

    • Absolute neutrophil count ≥ 1,500/μL and
    • Platelet count ≥ 100,000/μL
  • Patients must have no known bleeding diathesis or coagulopathy that would make intratumoral injection or biopsy unsafe.
  • Men and women of childbearing potential must agree to use adequate contraception prior to study entry and for up to six months.
  • Females of childbearing potential must have a negative urine or serum pregnancy test within one week prior to start of treatment.
  • Patients must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01017185
Other Study ID Numbers  ICMJE M06-10083
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Takara Bio Inc.
Study Sponsor  ICMJE Takara Bio Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert L Ferris, MD, PhD Division of Head and Neck Cancer Surgery, University of Pittsburgh Cancer Institute
PRS Account Takara Bio Inc.
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP