Phase 2 Study of Intralesional PV-10 for Metastatic Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: PV-10 (10% rose bengal disodium)
Intervention description: Intralesional injection for chemoablation
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: immune; vaccine; systemic; Metastatic Melanoma (AJCC Stage III or IV)

Summary:

      The primary objective of this study is to investigate the effectiveness of intralesional (IL)
      PV-10 for locoregional treatment of metastatic melanoma. This study will also include
      assessment of response in untreated bystander lesions following intralesional injection of
      PV-10 into targeted lesions. Additional objectives are to determine the safety profile of
      PV-10 following intralesional injection, and assess the pharmacokinetic profile of PV-10 in
      the bloodstream following intralesional injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women, age 18 years or older.

          -  Histologically or cytologically confirmed metastatic melanoma, AJCC (2002) Stage III
             (regional lymph node metastasis, in-transit metastasis or satellite metastasis) or
             Stage IV (distant metastasis).

          -  Measurable disease in at least one lesion ≥ 0.2 cm in diameter that can be accurately
             measured by ruler/caliper or ultrasound. Target, Non-Target and Bystander Lesions
             selected by discretion of Investigator.

          -  Performance Status: ECOG 0-2.

          -  Life Expectancy: At least 6 months.

          -  Hematopoietic:

               -  White blood cell count (WBC) no less than 2500/mm3 (2.5 x 10E9/L).

               -  Absolute neutrophil count (ANC) no less than 1,000/mm3 (1.0 x 10E9/L).

               -  Platelet count no less than 90,000/mm3 (90 x 10E9/L).

          -  Blood Chemistry:

               -  Creatinine no greater than 1.5 times the upper limit of normal (ULN).

               -  Total bilirubin no greater than 1.5 times the upper limit of normal (ULN).

               -  AST/ALT no greater than 3 times the upper limit of normal (ULN).

          -  Thyroid Function:

               -  Total T3 or free T3 (serum triiodothyronine), total T4 or free T4 (serum
                  thyroxine) and THS (serum thyrotropin) within normal limits.

          -  Cardiovascular Function:

               -  No clinically significant cardiovascular disease.

          -  Respiratory Function:

               -  No clinically significant respiratory disease.

          -  Immunological Function:

               -  No known immunodeficiency disease. Subjects must have adequate immune system
                  function in the opinion of the Investigator.

        Exclusion Criteria:

          -  Radiation therapy within 4 weeks of study treatment or to any Study Lesion within 12
             weeks of study treatment.

          -  Chemotherapy:

               -  Chemotherapy or other systemic cancer therapy within 4 weeks of study treatment
                  (6 weeks for nitrosoureas or mitomycin).

               -  Regional chemotherapy (limb infusion or perfusion) within 12 weeks of study
                  treatment.

          -  Local treatment (e.g., surgery, cryotherapy, radiofrequency ablation) to the treatment
             area within 4 weeks of study treatment.

          -  Investigational agents within 4 weeks (or 5 half-lives) of study treatment.

          -  Photosensitizing agents within 5 half-lives of study treatment.

          -  Anti-tumor vaccine therapy within 6 weeks of study treatment.

          -  Concurrent or Intercurrent Illness:

               -  Severe diabetes.

               -  Extremity complications due to diabetes.

               -  Significant concurrent or intercurrent illness, psychiatric disorders, or alcohol
                  or chemical dependence that would, in the opinion of the Investigator, compromise
                  their safety or compliance or interfere with interpretation of study results.

               -  Thyroid disease (subclinical or ongoing), goiter, partial thyroidectomy, previous
                  radioiodine- or surgically-treated Graves' hyperthyroidism or cystic fibrosis, or
                  taking thyroid hormone medication.

          -  Pregnancy:

               -  Female subjects who are pregnant or lactating.

               -  Female subjects who have positive serum ßHCG pregnancy test taken within 7 days
                  of PV-10 treatment.

               -  Fertile subjects who are not using effective contraception.