Clinical trial NCT01760499: Detection of Immune Cell Infiltration Into Melanomas Treated by PV-10, a Feasibility Study
Official title: Detection of Immune Cell Infiltration Into Melanomas Treated by PV-10, a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Melanoma
Keywords: skin
metastatic
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Provectus Pharmaceuticals
First posted: 2013-01-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to find out more about how PV-10 works in melanoma tumors. Researchers also want to find out if there are changes in the body's immune cells (cells that fight infection and illnesses) after PV-10 is given, both inside the melanoma tumors and circulating in the blood.


Eligibility criteria: 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 treatment
  * Patients with severe peripheral vascular disease (i.e., claudication occurring after less than 200 meters of walking, rest pain, ischemic ulceration or gangrene)
  * 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 fibrosis
  * 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.

Primary outcomes:
measure: Occurrence of Change in Infiltration of Immune Cells
timeFrame: At baseline and 7-14 days after PV-10 treatment
Secondary outcomes:
measure: Frequency and Phenotype of Circulating Immune Cells in Peripheral Blood Mononuclear Cells (PBMC)
timeFrame: At baseline, 7-14 days after treatment and 21-28 days after treatment
measure: Titer of Anti-tumor IgG in the Serum
timeFrame: At baseline, 7-14 days after treatment and 21-28 days after treatment
measure: Occurrence of Adverse Events (AEs)
timeFrame: During PV-10 administration visit, after 7-14 days, at study end (day 28 or early termination)
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Amod A. Sarnaik, M.D.
role: PRINCIPAL_INVESTIGATOR
References: