Phase 2 Study of Intralesional PV-10 for Metastatic Melanoma

Completed · Phase 2

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT00521053

Run by

Provectus Pharmaceuticals

People needed

80

Starts

2007-09-01

Expected to finish

2012-06-01

Last updated by the study team

2014-08-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• California Pacific Medical Center — San Francisco, California, United States
• University of Louisville — Louisville, Kentucky, United States
• St Luke's Hospital & Health Network — Bethlehem, Pennsylvania, United States
• M.D. Anderson Cancer Center — Houston, Texas, United States
• Sydney Melanoma Unit — Sydney, New South Wales, Australia
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.