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Phase 2 Study of Intralesional PV-10 for Metastatic Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Provectus Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00521053
First received: August 24, 2007
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Melanoma
Drug: PV-10 (10% rose bengal disodium)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Intralesional PV-10 in the Treatment of Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by Provectus Pharmaceuticals:

Primary Outcome Measures:
  • Objective Response Rate (ORR) of PV-10 Treated Lesions [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Objective Response Rate of Untreated Bystander Lesions [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    1-year survival


Enrollment: 80
Study Start Date: September 2007
Study Completion Date: June 2012
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PV-10 Drug: PV-10 (10% rose bengal disodium)
Intralesional injection for chemoablation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00521053

Locations
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
Sponsors and Collaborators
Provectus Pharmaceuticals
Investigators
Principal Investigator: John F Thompson, MD Sydney Melanoma Unit
  More Information

No publications provided

Responsible Party: Provectus Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00521053     History of Changes
Other Study ID Numbers: PV-10-MM-02
Study First Received: August 24, 2007
Results First Received: June 12, 2014
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Provectus Pharmaceuticals:
immune
vaccine
systemic
Metastatic Melanoma (AJCC Stage III or IV)

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 20, 2014