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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Melanoma
Intervention Drug: PV-10 (10% rose bengal disodium)
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PV-10
Hide Arm/Group Description 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.
Period Title: Treatment Phase
Started 80
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
Completed 80
Not Completed 0
Period Title: Observation Phase
Started 80
Completed 12
Not Completed 68
Reason Not Completed
Disease Progression             55
Additional PV-10 via alternate protocol             8
Death             2
Adverse Event             1
Other non-study melanoma treatment             1
Physician Decision             1
Arm/Group Title PV-10
Hide Arm/Group Description PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation.
Overall Number of Baseline Participants 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 80 participants
70.0
(33 to 97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants
Female
32
  40.0%
Male
48
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 participants
United States 27
Australia 53
American Joint Committee on Cancer (AJCC) Stage at Baseline   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 participants
IIIB 38
IIIC 24
M1a 3
M1b 5
M1c 10
[1]
Measure Description: 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 participants
Less than 10 Lesions 44
10 or more Lesions 29
Too Numerous to Count 7
Prior Interventions   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 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]
Measure Description: Participants may have had more than one prior intervention.
Number of Prior Interventions  
Median (Full Range)
Unit of measure:  Prior interventions
Number Analyzed 80 participants
6
(1 to 19)
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 participants
0 53
1 25
2 2
[1]
Measure Description:

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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 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]
Measure Description: Participants were categorized at baseline according to tumor burden that was not injected with PV-10.
1.Primary Outcome
Title Objective Response Rate (ORR) of PV-10 Treated Lesions
Hide Description 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.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT participants
Arm/Group Title PV-10
Hide Arm/Group Description:
PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation.
Overall Number of Participants Analyzed 80
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
51.3
(39.8 to 62.6)
2.Secondary Outcome
Title Objective Response Rate of Untreated Bystander Lesions
Hide Description 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.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT participants having at least one uninjected dermal bystander lesion designated at baseline (some ITT participants did not have at least one bystander lesion).
Arm/Group Title PV-10
Hide Arm/Group Description:
PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation.
Overall Number of Participants Analyzed 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
33.3
(19.6 to 49.6)
3.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description 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.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stage III Stage IV
Hide Arm/Group Description:
Participants reporting Stage III disease at baseline
Participants reporting Stage IV disease at baseline
Overall Number of Participants Analyzed 62 18
Median (95% Confidence Interval)
Unit of Measure: Months
3.7
(2.9 to 4.5)
1.9
(1.6 to 2.1)
4.Secondary Outcome
Title Overall Survival
Hide Description 1-year survival
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT participants
Arm/Group Title Stage III Stage IV
Hide Arm/Group Description:
Participants reporting Stage III disease at baseline
Participants reporting Stage IV disease at baseline
Overall Number of Participants Analyzed 62 18
Measure Type: Number
Unit of Measure: percentage of participants
89 39
5.Post-Hoc Outcome
Title Rate of Complete Response
Hide Description 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; Complete Response Rate (CRR) = %CR.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT participants having all baseline disease injected with PV-10
Arm/Group Title All Lesions Treated
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 28
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
50
(30.6 to 69.4)
Time Frame Adverse event data were collected over the study interval (52 weeks) and followed until resolution. Events on-going at time of withdrawal were followed until resolution or for a period of at least 28 days from last dose of study medication.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PV-10
Hide Arm/Group Description PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation.
All-Cause Mortality
PV-10
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
PV-10
Affected / at Risk (%)
Total   14/80 (17.50%) 
Cardiac disorders   
Left ventricular hypertrophy  1  1/80 (1.25%) 
Atrial fibrillation  1  1/80 (1.25%) 
Endocrine disorders   
Pituitary disorder  1  1/80 (1.25%) 
Gastrointestinal disorders   
Dysphagia  1  1/80 (1.25%) 
General disorders   
Injection site oedema  1  1/80 (1.25%) 
Injection site swelling  1  2/80 (2.50%) 
Injection site ulcer  1  1/80 (1.25%) 
Pyrexia  1  1/80 (1.25%) 
Injection site necrosis  1  1/80 (1.25%) 
Injection site pain  1  2/80 (2.50%) 
Injection site infection  1  1/80 (1.25%) 
Injection site vesicles  1  1/80 (1.25%) 
Hepatobiliary disorders   
Cholecystitis  1  1/80 (1.25%) 
Infections and infestations   
Viral infection  1  1/80 (1.25%) 
Pneumonia  1  2/80 (2.50%) 
Injury, poisoning and procedural complications   
Back injury  1  1/80 (1.25%) 
Delayed recovery from anaesthesia  1  1/80 (1.25%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  1/80 (1.25%) 
Skin and subcutaneous tissue disorders   
Photosensitivity reaction  1  1/80 (1.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PV-10
Affected / at Risk (%)
Total   80/80 (100.00%) 
Gastrointestinal disorders   
Abdominal pain  1  4/80 (5.00%) 
Constipation  1  10/80 (12.50%) 
Diarrhoea  1  8/80 (10.00%) 
Nausea  1  17/80 (21.25%) 
Vomiting  1  7/80 (8.75%) 
General disorders   
Fatigue  1  5/80 (6.25%) 
Injection site cellulitis  1  4/80 (5.00%) 
Injection site discolouration  1  25/80 (31.25%) 
Injection site erythema  1  11/80 (13.75%) 
Injection site infection  1  5/80 (6.25%) 
Injection site inflammation  1  6/80 (7.50%) 
Injection site oedema  1  32/80 (40.00%) 
Injection site pain  1  65/80 (81.25%) 
Injection site photosensitivity reaction  1  6/80 (7.50%) 
Injection site pruritus  1  17/80 (21.25%) 
Injection site rash  1  4/80 (5.00%) 
Injection site swelling  1  20/80 (25.00%) 
Injection site ulcer  1  4/80 (5.00%) 
Injection site vesicles  1  30/80 (37.50%) 
Injection site warmth  1  4/80 (5.00%) 
Lethargy  1  4/80 (5.00%) 
Oedema peripheral  1  5/80 (6.25%) 
Infections and infestations   
Nasopharyngitis  1  6/80 (7.50%) 
Metabolism and nutrition disorders   
Decreased appetite  1  5/80 (6.25%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  7/80 (8.75%) 
Back pain  1  4/80 (5.00%) 
Musculoskeletal pain  1  5/80 (6.25%) 
Nervous system disorders   
Headache  1  14/80 (17.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eric Wachter, Chief Technology Officer
Organization: Provectus Biopharmaceuticals, Inc.
Phone: 1-865-769-4011 ext 23
EMail: wachter@pvct.com
Layout table for additonal information
Responsible Party: Provectus Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00521053    
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