Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Vaccines

Intralesional injection for chemoablation

PV-10 (10% rose bengal disodium)

John F Thompson, MD

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.

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.

Phase 2 Study of Intralesional PV-10 for Metastatic Melanoma

A Phase 2 Study of Intralesional PV-10 in the Treatment of Metastatic Melanoma

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.

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 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.

Provectus Pharmaceuticals

PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation.

PV-10

Age, Continuous

Sex: Female, Male

United States

Australia

Region of Enrollment

IIIB

IIIC

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).

American Joint Committee on Cancer (AJCC) Stage at Baseline

Less than 10 Lesions

10 or more Lesions

Too Numerous to Count

Tumor Burden in Skin

Excision

Nodal Biopsy

Regional Chemotherapy

Immunotherapy

Radiotherapy

Investigational Agents

Systemic Chemotherapy

Distal Amputation

Other

Participants may have had more than one prior intervention.

Prior Interventions

Number of Prior Interventions

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.

Eastern Cooperative Oncology Group (ECOG) Performance Status

Untreated Visceral Disease

One or More Lesions Not Measured and Untreated

All Lesions Treated Except Bystanders

All Lesions Treated

Participants were categorized at baseline according to tumor burden that was not injected with PV-10.

Untreated Disease Burden

Eric Wachter, Chief Technology Officer

Objective Response Rate (ORR) of PV-10 Treated Lesions

ITT participants having at least one uninjected dermal bystander lesion designated at baseline (some ITT participants did not have at least one bystander lesion).

Objective Response Rate of Untreated Bystander Lesions

Participants reporting Stage III disease at baseline

Stage III

Participants reporting Stage IV disease at baseline

Stage IV

Progression Free Survival (PFS)

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.

ITT participants having all baseline disease injected with PV-10

Rate of Complete Response

Overall Survival

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.

Spots Global Cancer Trial Database for Phase 2 Study of Intralesional PV-10 for Metastatic Melanoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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