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Detection of Immune Cell Infiltration Into Melanomas Treated by PV-10, a Feasibility Study

Phase 1
18 Years
Open (Enrolling)

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Trial Information

Detection of Immune Cell Infiltration Into Melanomas Treated by PV-10, a Feasibility Study

Inclusion Criteria:

- Patients who are diagnosed with metastatic melanoma, or who are suspected to have
metastatic melanoma and are subsequently proven to have metastatic melanoma by biopsy

- Patients who are planned to undergo surgical resection of at least two foci of
palpable cutaneous or subcutaneous metastatic melanoma, for either palliative or
therapeutic intent and who consent for preoperative core biopsies of at least two of
the resectable lesions prior to surgery

- Patients who have given informed consent to participate in the study

Exclusion Criteria:

- Patients who decline consent for this study

- Patients who have previously received PV-10 therapy

- Patients who were suspected to have metastatic melanoma but are not proven by
preoperative biopsy will be replaced and not counted against the accrual goal

- Patients who do not undergo surgical resection of at least two metastatic melanoma
lesions including the PV-10 treated lesion will be replaced and not counted against
the accrual goal.

- Patients whose melanoma lesions are contiguous with, encompass or infiltrate a major
blood vessel

- Patients with an allergy to shellfish due to reported cross-reactivity to PV-10

- Patients with previous sensitivity to iodide

- Patients who do not have a treatable target lesion on a portion of the body other
than the head or neck

- Concurrent or Intercurrent Illness:

- Patients with a condition of impaired wound healing (such as uncontrolled
diabetes mellitus or immunosuppressive steroid dependence) such that in the
opinion of the PI it is unsafe for the patient to undergo intralesional PV-10

- Patients with severe peripheral vascular disease (i.e., claudication occurring
after less than 200 meters of walking, rest pain, ischemic ulceration or

- Patients with significant concurrent or intercurrent illness, psychiatric
disorders, or alcohol or chemical dependence that would, in the opinion of the
principal investigator (PI), compromise their safety or compliance or interfere
with interpretation of study results

- Patients with uncontrolled thyroid disease, goiter, partial thyroidectomy,
previous radioiodine or surgically-treated Graves' hyperthyroidism or cystic

- Patients with clinically significant cardiovascular, cerebrovascular, peripheral
vascular, renal, gastrointestinal, pulmonary, immunological, endocrine, bone
marrow or central nervous system disorders that have required hospitalization
within the past 12 months

- Pregnancy

- Female patients who have a positive pregnancy test or are lactating.

- Fertile patients who do not agree to use effective contraception (i.e., oral
contraceptives, intrauterine devices, double barrier methods such as condoms and
diaphragms, abstinence or equivalent measures) beginning at the time of signing
consent until after surgery.

- Patients who are dependent upon concomitant medications that predispose to
photosensitivity who cannot stop the medication(s) from the period starting 24 hours
prior to and ending 24 hours after PV-10 treatment will be excluded.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Occurrence of Change in Infiltration of Immune Cells

Outcome Description:

The pre-treatment blood sample and tumor biopsies will be the control for the post-PV-10 blood samples and resected tumor samples. Tumor core needle biopsies will be collected from the designated injected and uninjected lesions one week prior to intralesional PV-10 therapy. Biopsy samples will be fixed in formalin and embedded in paraffin for immunohistochemical (IHC) staining. On day 0, the injected lesion will be treated with up to 5 mL of PV-10. Seven to 14 days after intralesional PV-10 treatment, the injected and uninjected lesions will be resected. A portion of each tumor equivalent to a core needle biopsy specimen will be fixed in formalin and embedded in paraffin for IHC staining. Immune cell infiltration will be compared between untreated baseline lesions and post-treatment lesions (injected or uninjected) by a blinded pathologist at Moffitt Cancer Center. Measurement is the ordinal level of the T-cell infiltration into tumors with three levels: 0, no brisk, and brisk.

Outcome Time Frame:

At baseline and 7-14 days after PV-10 treatment

Safety Issue:


Principal Investigator

Amod A. Sarnaik, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

January 2013

Completion Date:

March 2014

Related Keywords:

  • Melanoma
  • skin
  • metastatic
  • Melanoma



H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612