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Refractory Head and Neck CancerPhase 1NCT01017185

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

A Phase 1 study testing HF10 in people with Refractory Head and Neck Cancer and Squamous Cell Carcinoma, Skin, run by Takara Bio Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HF10
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
5 sitesUnited States
Study dates
Aug 2009to Mar 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Mary Crowley Cancer Research Center

    Dallas, Texas, 75230

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Montefiore Medical Center

    The Bronx, New York, 10461-2374

Other trials in United States

About this study

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.

Read the 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.

Being tested
HF10
Medical subject headings
Head and Neck Neoplasms, Carcinoma, Squamous Cell, Breast Neoplasms, Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HF10Drug

Study groups in NCT01017185
Study groupRoleWhat they receive
Oncolytic virotherapy, intratumoral injection of HF10ExperimentalNot described
Receives: Drug: HF10

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of the local tumor response of the HF10-injected tumor by a modified target Response Evaluation Criteria In Solid Tumors (RECIST) method

    Measured: one year

Secondary outcomes (3)

  1. Adverse events, vital signs, electrocardiogram(ECG), clinical laboratory tests, and physical exercise

    Measured: one year

  2. Histological tumor response by biopsy

    Measured: one year

  3. Overall tumor response of the HF10-injected tumor plus additional non-injected target tumors.

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionMay 2014
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01017185
Sponsor's protocol ID
M06-10083
Status last verified
May 2015
First submitted
18 Nov 2009
Last updated
23 May 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HF10 in people with Refractory Head and Neck Cancer and Squamous Cell Carcinoma, Skin, run by Takara Bio Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01017185.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019.

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