Intralesional PV-10 Chemoablation of Metastatic Melanoma - Full Text View

Sponsor:	Provectus Pharmaceuticals
Information provided by:	Provectus Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00219843

Purpose

The objective of this study is to investigate the safety of intralesional (IL) PV-10 for the treatment of metastatic melanoma. This study will also include a preliminary assessment of response of treated and untreated lesions by clinical evaluation at follow-up of 12 to 24 weeks following IL PV-10 treatment.

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

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 1 Safety and Tolerability Study of Intralesional PV-10 Chemoablation in Subjects With Metastatic Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Melanoma

U.S. FDA Resources

Further study details as provided by Provectus Pharmaceuticals:

Primary Outcome Measures:

Safety: adverse experience

Secondary Outcome Measures:

Efficacy: objective response rate of target lesions and untreated non-target lesions

Estimated Enrollment:	20
Study Start Date:	August 2005
Study Completion Date:	August 2007

Detailed Description:

This is a two center, open label, ascending dose study. Subjects with at least two measurable melanoma lesions will receive a single intralesional injection of 10% PV-10 solution into each of one to twenty (20) target lesions. Additionally, one to three measurable untreated non-target lesions will be followed for assessment of bystander response. Systemic and locoregional adverse events will be monitored over the study interval. Dose escalation will be made only if no subjects at the first dose level have a Grade 3 non-hematological or Grade 4 hematological toxicity over a period of two weeks after PV-10 administration. Subject accrual and PV-10 administration at the second dose level will be stopped if more than 1 subject has a treatment related Grade 3 non-hematological or Grade 4 hematological toxicity within a period of two weeks after PV-10 administration.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed metastatic melanoma, American Joint Committee on Cancer (AJCC) Stage III (regional lymph node metastasis, in-transit metastasis or satellite metastasis) or Stage IV (distant metastasis)
Measurable disease in at least two lesions, each lesion ≤ 6 cm in diameter
Performance status: ECOG 0-2
Life expectancy: at least 6 months
Hematopoietic:
- White blood cell count (WBC) at least 3000/mm3
- Absolute neutrophil count (ANC) at least 1.5 (1,500/mm3)
- Platelet count at least 100,000/mm3
Renal function:
- Creatinine ≤ 2.0 mg/dL
Hepatic function:
- Bilirubin ≤ 2.0 mg/dL
- AST/ALT ≤ 3 times the upper limit of normal (ULN)
Cardiovascular function:
- No major cardiovascular disease
Thyroid function:
- T3 (serum triiodothyronine), T4 (serum thyroxine) and THS (serum thyrotropin) within normal limits
Immunological function:
- Adequate immune system function in the opinion of the investigator

Exclusion Criteria:

Radiation therapy within 4 weeks or to any study lesion within 12 weeks
Chemotherapy or other systemic cancer therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin) or regional chemotherapy (limb infusion or perfusion) within 12 weeks
Local treatment (e.g., surgery, cryotherapy, radiofrequency ablation) to the treatment area within 4 weeks
Investigational agents within 4 weeks (or 5 half-lives)
Anti-tumor vaccine therapy within 12 weeks
Concurrent illness:
- Severe diabetes or extremity complications due to diabetes
- Significant concurrent disease or illness, psychiatric disorders, or alcohol or chemical dependence that would, in the opinion of the investigator, compromise subject safety or compliance or interfere with interpretation of study results
- Thyroid autoregulatory dysfunction, including thyroid disease (subclinical or ongoing), goiter, partial thyroidectomy, prior radioiodine- or surgically-treated Graves' hyperthyroidism, or cystic fibrosis
- Pregnancy or fertile female subjects who are not using effective contraception
Concurrent medications:
- Subjects taking medications with a significant risk of photosensitization, such as thiazides, within one week (or 5 half-lives) of study treatment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219843

Locations

Australia, New South Wales
Sydney Melanoma Unit
North Sydney, New South Wales, Australia, 2060
Newcastle Melanoma Unit
Waratah, New South Wales, Australia, 2298

Sponsors and Collaborators

Provectus Pharmaceuticals

Investigators

Study Director:

Eric Wachter, Ph.D.

Provectus Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	PV-10-MM-01
Study First Received:	September 14, 2005
Last Updated:	August 22, 2007
ClinicalTrials.gov Identifier:	NCT00219843 History of Changes
Health Authority:	United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Provectus Pharmaceuticals:

Stage III and IV melanoma

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on February 08, 2010