Trial record 12 of 14 for:    Provectus

Phase 2 Study of Intralesional PV-10 for Metastatic Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00521053
Recruitment Status : Completed
First Posted : August 27, 2007
Results First Posted : August 25, 2014
Last Update Posted : August 25, 2014
Information provided by (Responsible Party):
Provectus Pharmaceuticals

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Melanoma
Intervention: Drug: PV-10 (10% rose bengal disodium)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
PV-10 PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation. In the treatment phase, participants received a single IL injection of PV-10 into each of up to 20 study lesions on day 0 (i.e., one cycle). Treatment cycles could be repeated at weeks 8, 12 and 16 for new non-target lesions or existing target or non-target lesions not exhibiting complete response (i.e., complete disappearance). Participants were observed for 52 weeks. Radiologic assessments of visceral disease status were performed every 12 weeks throughout the study and patients were transitioned into survival follow-up if at any time the investigator identified clinical or radiologic evidence of distant progression. No other melanoma therapy was permitted during the study interval.

Participant Flow for 2 periods

Period 1:   Treatment Phase
Received 1 Cycle of PV-10   35 
Received 2 Cycles of PV-10   26 
Received 3 Cycles of PV-10   16 
Received 4 Cycles of PV-10   3 

Period 2:   Observation Phase
Disease Progression                55 
Additional PV-10 via alternate protocol                8 
Death                2 
Adverse Event                1 
Other non-study melanoma treatment                1 
Physician Decision                1 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
PV-10 PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation.

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (33 to 97) 
[Units: Participants]
Female   32 
Male   48 
Region of Enrollment 
[Units: Participants]
United States   27 
Australia   53 
American Joint Committee on Cancer (AJCC) Stage at Baseline [1] 
[Units: Participants]
IIIB   38 
IIIC   24 
M1a   3 
M1b   5 
M1c   10 
[1] Participants were staged clinically at baseline based on cutaneous and subcutaneous, nodal and visceral tumor burden. Stage III participants had disease confined to cutaneous, subcutaneous and/or nodal sites. Stage IV participants had distant metastatic disease (i.e., distant cutaneous or subcutaneous metastases or visceral metastases).
Tumor Burden in Skin 
[Units: Participants]
Less than 10 Lesions   44 
10 or more Lesions   29 
Too Numerous to Count   7 
Prior Interventions [1] 
[Units: Participants]
Excision   80 
Nodal Biopsy   50 
Regional Chemotherapy   19 
Immunotherapy   17 
Radiotherapy   17 
Investigational Agents   11 
Systemic Chemotherapy   10 
Distal Amputation   7 
Other   6 
[1] Participants may have had more than one prior intervention.
Number of Prior Interventions 
[Units: Prior interventions]
Median (Full Range)
 (1 to 19) 
Eastern Cooperative Oncology Group (ECOG) Performance Status [1] 
[Units: Participants]

Participants were staged clinically at baseline using the ECOG Performance Status scale:

GRADE 0: Fully active, able to carry on all pre-disease performance without restriction. GRADE 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. GRADEe 2: Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours.

Untreated Disease Burden [1] 
[Units: Participants]
Untreated Visceral Disease   18 
One or More Lesions Not Measured and Untreated   8 
All Lesions Treated Except Bystanders   26 
All Lesions Treated   28 
[1] Participants were categorized at baseline according to tumor burden that was not injected with PV-10.

  Outcome Measures

1.  Primary:   Objective Response Rate (ORR) of PV-10 Treated Lesions   [ Time Frame: 52 weeks ]

2.  Secondary:   Objective Response Rate of Untreated Bystander Lesions   [ Time Frame: 52 weeks ]

3.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: 52 weeks ]

4.  Secondary:   Overall Survival   [ Time Frame: 52 weeks ]

5.  Post-Hoc:   Rate of Complete Response   [ Time Frame: 52 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Eric Wachter, Chief Technology Officer
Organization: Provectus Biopharmaceuticals, Inc.
phone: 1-865-769-4011 ext 23

Responsible Party: Provectus Pharmaceuticals Identifier: NCT00521053     History of Changes
Other Study ID Numbers: PV-10-MM-02
First Submitted: August 24, 2007
First Posted: August 27, 2007
Results First Submitted: June 12, 2014
Results First Posted: August 25, 2014
Last Update Posted: August 25, 2014