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

NCT01760499 | Completed Phase 1

• 1 other identifier: MCC-17183
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Keywords

skin; metastatic

Outcome Measures

Primary Outcomes (1)

• Occurrence of Change in Infiltration of Immune Cells

  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.

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

Secondary Outcomes (3)

• Frequency and Phenotype of Circulating Immune Cells in Peripheral Blood Mononuclear Cells (PBMC)

  At baseline, 7-14 days after treatment and 21-28 days after treatment

• Titer of Anti-tumor IgG in the Serum

  At baseline, 7-14 days after treatment and 21-28 days after treatment

• Occurrence of Adverse Events (AEs)

  During PV-10 administration visit, after 7-14 days, at study end (day 28 or early termination)

Study Arms (1)

Immunotherapy Followed by Surgery

EXPERIMENTAL

PV-10 administration, adverse events assessment, surgery to remove melanoma tumors, follow-up visit.

Drug: PV-10; Procedure: Surgery

Interventions

PV-10 DRUG

PV-10 administration: Within one week after completing the screening tests (or the same day as the screening tests), participants will be scheduled to have the study drug (PV-10) administered. PV-10 is given as an injection with a needle, directly into one of the participant's tumors. Participants will be given an injection of a numbing medication before the PV-10 is given.

Also known as: 10% rose bengal disodium

Immunotherapy Followed by Surgery

Surgery PROCEDURE

Surgery to remove melanoma tumors (Day 7-14): About 7-14 days after the PV-10 is given, participants will have surgery to remove their melanoma tumors. A piece of the tumor that was injected with PV-10 along with a piece of one other tumor will be sent to the laboratory for testing as part of the study.

Immunotherapy Followed by Surgery

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Provectus Pharmaceuticals: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amod A. Sarnaik, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 21, 2012
• First Posted: January 4, 2013
• Study Start: January 24, 2013
• Primary Completion: December 29, 2015
• Study Completion: April 1, 2017
• Last Updated: April 19, 2017

Record last verified: 2017-04

Locations

US (1)