Phase 2 Study of Intralesional PV-10 for Metastatic Melanoma
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ClinicalTrials.gov Identifier: NCT00521053 |
Recruitment Status
:
Completed
First Posted
: August 27, 2007
Results First Posted
: August 25, 2014
Last Update Posted
: August 25, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Melanoma | Drug: PV-10 (10% rose bengal disodium) | Phase 2 |
This is a multicenter, open-label, single-agent study. Subjects with at least one melanoma lesion ≥ 0.2 cm in diameter that can be accurately measured by ruler/caliper or ultrasound will receive intralesional injection of PV-10 into each of up to twenty (20) Study Lesions. Additionally, one to two measurable Bystander Lesions may remain untreated and will be followed for assessment of bystander response.
To accurately reflect anticipated clinical use, repeat dosing of treated lesions will be allowed at the Investigator's discretion at weeks 8, 12 and 16 following initial treatment for those lesions not exhibiting complete response. Subjects will be followed for 52 weeks following initial treatment with PV-10.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 80 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Study of Intralesional PV-10 in the Treatment of Metastatic Melanoma |
Study Start Date : | September 2007 |
Actual Primary Completion Date : | May 2010 |
Actual Study Completion Date : | June 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: PV-10 |
Drug: PV-10 (10% rose bengal disodium)
Intralesional injection for chemoablation
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- Objective Response Rate (ORR) of PV-10 Treated Lesions [ Time Frame: 52 weeks ]Using modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for cutaneous or subcutaneous target lesions assessed by ruler, caliper or ultrasound: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate (ORR) = %CR + %PR.
- Objective Response Rate of Untreated Bystander Lesions [ Time Frame: 52 weeks ]Using modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for designated, untreated cutaneous or subcutaneous bystander lesions assessed by ruler, caliper or ultrasound: Complete Response (CR), disappearance of all bystander lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of bystander lesions; Objective Response Rate (ORR) = %CR + %PR.
- Progression Free Survival (PFS) [ Time Frame: 52 weeks ]Progression is defined using modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or significant worsening of non-target disease (e.g., a measurable increase in non-target lesions or the appearance of new lesions) indicative of disease progression.
- Overall Survival [ Time Frame: 52 weeks ]1-year survival

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00521053
United States, California | |
California Pacific Medical Center | |
San Francisco, California, United States, 94115 | |
United States, Kentucky | |
University of Louisville | |
Louisville, Kentucky, United States, 40202 | |
United States, Pennsylvania | |
St Luke's Hospital & Health Network | |
Bethlehem, Pennsylvania, United States, 18015 | |
United States, Texas | |
M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
Australia, New South Wales | |
Sydney Melanoma Unit | |
Sydney, New South Wales, Australia, 2050 | |
Australia, Queensland | |
Princess Alexandra Hospital | |
Woolloongabba, Queensland, Australia, 4102 | |
Australia, South Australia | |
Royal Adelaide Hospital | |
Adelaide, South Australia, Australia, 5000 |
Principal Investigator: | John F Thompson, MD | Sydney Melanoma Unit |
Responsible Party: | Provectus Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00521053 History of Changes |
Other Study ID Numbers: |
PV-10-MM-02 |
First Posted: | August 27, 2007 Key Record Dates |
Results First Posted: | August 25, 2014 |
Last Update Posted: | August 25, 2014 |
Last Verified: | August 2014 |
Keywords provided by Provectus Pharmaceuticals:
immune vaccine systemic Metastatic Melanoma (AJCC Stage III or IV) |
Additional relevant MeSH terms:
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |