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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
Sponsor:
Information provided by (Responsible Party):
Provectus Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE August 24, 2007
First Posted Date  ICMJE August 27, 2007
Results First Submitted Date  ICMJE June 12, 2014
Results First Posted Date  ICMJE August 25, 2014
Last Update Posted Date August 25, 2014
Study Start Date  ICMJE September 2007
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 24, 2007)
Objective Response Rate (ORR) of PV-10 Treated Lesions [ Time Frame: 52 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2007)
Response in untreated bystander lesions following intralesional injection of PV-10 into treated lesions [ Time Frame: 52 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 2 Study of Intralesional PV-10 for Metastatic Melanoma
Official Title  ICMJE A Phase 2 Study of Intralesional PV-10 in the Treatment of Metastatic Melanoma
Brief 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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Melanoma
Intervention  ICMJE Drug: PV-10 (10% rose bengal disodium)
Intralesional injection for chemoablation
Study Arms  ICMJE Experimental: PV-10
Intervention: Drug: PV-10 (10% rose bengal disodium)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 24, 2007)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00521053
Other Study ID Numbers  ICMJE PV-10-MM-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Provectus Pharmaceuticals
Study Sponsor  ICMJE Provectus Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John F Thompson, MD Sydney Melanoma Unit
PRS Account Provectus Pharmaceuticals
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP