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Trial record 6 of 11 for: provectus
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PV-10 Intralesional Injection vs Systemic Chemotherapy for Treatment of Locally Advanced Cutaneous Melanoma
This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2014 by Provectus Pharmaceuticals
Sponsor:
Provectus Pharmaceuticals
Information provided by (Responsible Party):
Provectus Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02288897
First received: November 4, 2014
Last updated: November 7, 2014
Last verified: November 2014
History of Changes

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Purpose

This is an international multicenter, open-label, randomized controlled trial (RCT) of single-agent intralesional PV-10 versus systemic chemotherapy with dacarbazine (DTIC) or temozolomide (TMZ) to assess treatment of locally advanced cutaneous melanoma in patients who are BRAF V600E wild-type and have failed or are not otherwise candidates for ipilimumab or another immune checkpoint inhibitor. Subjects in the comparator arm will receive the Investigator's choice of dacarbazine or temozolomide as determined by Investigator preference and/or local availability of the agent. Effectiveness will be assessed by comparison of progression-free survival (PFS) between all intent-to-treat (ITT) subjects in the two study treatment arms.

Condition Intervention Phase
Melanoma Recurrent
Drug: PV-10 (10% rose bengal disodium)
Drug: Dacarbazine or temozolomide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PV-10 Intralesional Injection vs Systemic Chemotherapy for Treatment of Locally Advanced Cutaneous Melanoma Without Distant Metastases

Resource links provided by NLM:

MedlinePlus related topics: Melanoma
Drug Information available for: Rose Bengal Dacarbazine Temozolomide
Genetic and Rare Diseases Information Center resources: Melanoma, Familial Neuroepithelioma
U.S. FDA Resources

Further study details as provided by Provectus Pharmaceuticals:

Primary Outcome Measures:

Progression-free survival (PFS) [ Time Frame: Assessed every 12 weeks up to 18 months ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

Complete response rate (CRR) [ Time Frame: Assessed every 12 weeks up to 18 months ] [ Designated as safety issue: No ]
Duration of complete response [ Time Frame: Assessed every 12 weeks up to 18 months ] [ Designated as safety issue: No ]
Change in total symptom score from baseline using the patient reported Skindex-16 instrument [ Time Frame: Assessed 12 weeks after Day 1 ] [ Designated as safety issue: No ]
Overall survival (OS) [ Time Frame: Assessed every 12 weeks up to 18 months ] [ Designated as safety issue: No ]
Number of participants with adverse events [ Time Frame: Assessed every 4 weeks until 28 days after last treatment ] [ Designated as safety issue: Yes ]
Safety and tolerability will be assessed by monitoring the frequency, duration, severity and attribution of adverse events and evaluating changes in laboratory values and vital signs.


Estimated Enrollment: 225
Study Start Date: December 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PV-10
Subjects will receive intralesional PV-10 to all Study Lesions on study Day 1. PV-10 should be re-administered at Day 29 (Week 5) and/or Day 57 (Week 9) for treatment of any existing disease on the skin (not exceeding 25 Study Lesions) and thereafter at 28-day intervals until complete response, disease progression or study termination occurs.
Drug: PV-10 (10% rose bengal disodium)
Active Comparator: Systemic Chemotherapy
Subjects will receive systemic dacarbazine (intravenously at 850 m/m2) or oral temozolomide (orally at 200 mg/m2 daily for 5 consecutive days), initially administered over three consecutive 28-day cycles. Dacarbazine or temozolomide should be continued on a 28-day cycle until complete response, disease progression or study termination occurs.
Drug: Dacarbazine or temozolomide

Detailed Description:

Subjects will be randomized using a 2:1 treatment allocation (i.e. two-thirds of the subjects will receive PV-10).

Subjects in the comparator arm who have completed at least 1 cycle of dacarbazine or temozolomide and who meet the study protocol definition of disease progression but do not have evidence of distant cutaneous, subcutaneous, active nodal or visceral metastases will be eligible to enter the crossover portion of the study and receive PV-10.

When the last subject randomized to the comparator arm has completed the Week 13 visit, the database has been frozen, and the primary data analysis is complete, all subjects randomized to the comparator arm and remaining in the treatment or response follow-up portions of the study will have the opportunity to enter the crossover portion of the study and receive PV-10.

Subjects crossing over must meet all study inclusion and exclusion criteria at the time of crossover.

Assessment of progression will be performed by an Independent Review Committee (IRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) ver. 1.1 criteria. Events signaling progression include distant or nodal disease progression, clinically significant progression or death. All secondary endpoints involving disease response and progression will be based on the IRC determination. Change in disease symptoms will be based on patient reported outcome.

An interim assessment of efficacy and safety will be performed by the IRC when 50% of the events required for the primary endpoint have occurred.
Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

Age 18 years or older, male or female
Histologically or cytologically confirmed melanoma
Stage IIIB or IIIC recurrent, satellite or in-transit cutaneous or subcutaneous melanoma
At least 2 cutaneous Target Lesions > 5 mm in longest diameter. Target Lesions should be at least 10 mm from any other lesion
No lesion > 30 mm in longest diameter; and no more than 20 lesions
Calculated required PV-10 dose ≤ 15 mL (based on total tumor burden)
Performance Status: Eastern Cooperative Oncology Group (ECOG) 0-2
Failed, did not tolerate, or not a candidate for (due to co-morbidities, pre-existing autoimmune disease or drug unavailability) treatment with ipilimumab or another immune checkpoint inhibitor
Not a candidate for treatment with vemurafenib, dabrafenib or trametinib (i.e., BRAF V600E wild-type)
Life Expectancy: At least 6 months.

Clinical Laboratories:
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L and platelet count ≥100 x 10^9/L
Creatinine ≤ 3 times the upper limit of normal (ULN)
Estimated creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2
Total bilirubin ≤ 3 times the upper limit of normal (ULN)
Aspartate transaminase (AST), alanine transaminase (ALT) and alkaline phosphatase (ALP) ≤ 5 times the upper limit of normal (ULN)
Lactate dehydrogenase (LDH) ≤ 2 times the upper limit of normal (ULN).
Thyroid function abnormality ≤ Grade 2

Exclusion Criteria:

Presence or history of visceral or distant cutaneous or subcutaneous melanoma metastasis
Presence of active nodal metastasis
Presence of more than 20 melanoma lesions
Radiation therapy to any Study Lesion within 4 weeks of initial study treatment.
Chemotherapy or other systemic cancer therapy within 4 weeks of initial study treatment (6 weeks for nitrosoureas or mitomycin), or regional chemotherapy (limb infusion or perfusion) within 12 weeks of initial study treatment
Immunotherapy for cancer within 4 weeks of initial study treatment
Local treatment (e.g., surgery, cryotherapy, laser ablation) to any Study Lesion within 4 weeks of initial study treatment
Anti-tumor vaccine therapy within 6 weeks of initial study treatment.
Investigational agents within 4 weeks (or 5 half-lives) of initial study treatment.

Concurrent or Intercurrent Illness:
Impaired wound healing or other extremity complications due to diabetes mellitus in subjects whose Study Lesions are located in an extremity
Severe peripheral vascular disease in subjects whose Study Lesions are located in an extremity
Significant concurrent or intercurrent illness, psychiatric disorders, or alcohol or chemical dependence that would, in the opinion of the Investigator, compromise the subject's safety or compliance or interfere with interpretation of study results.
Uncontrolled thyroid disease or cystic fibrosis
Clinically significant acute or unstable cardiovascular, cerebrovascular (stroke), renal, gastrointestinal, pulmonary, immunological, endocrine, or central nervous system disorders

Pregnancy:
Female subjects who are pregnant or lactating
Female subjects who have positive serum pregnancy test taken within 14 days of study treatment
Female subjects of child-bearing potential who are not using effective contraception (e.g., oral contraceptives, intrauterine devices, double barrier methods such as condoms and diaphragms, abstinence or equivalent measures)

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: NCT02288897

Contacts
Contact: Eric Wachter, Ph.D. +1 865 769 4011 ext 23 wachter@pvct.com

Sponsors and Collaborators
Provectus Pharmaceuticals
Investigators
Study Director: Eric Wachter, Ph.D. Provectus Pharmaceuticals, Inc.
More Information

No publications provided

Responsible Party: Provectus Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02288897 History of Changes
Other Study ID Numbers: PV-10-MM-31
Study First Received: November 4, 2014
Last Updated: November 7, 2014
Health Authority: United States: Food and Drug Administration

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
Temozolomide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 11, 2014

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