Trials / Unknown

UnknownNCT00986661

A Study to Assess PV-10 Chemoablation of Cancer of the Liver

A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of PV-10 Chemoablation of Cancer Metastatic to the Liver or Hepatocellular Carcinoma Not Amenable to Resection or Transplant

Status: Unknown
Phase: Phase 1
Study type: Interventional
Enrollment: 78 (estimated)

Sponsor: Provectus Biopharmaceuticals, Inc. · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This open-label study will evaluate the safety, tolerability, pharmacokinetics and effect on tumor growth following a single intralesional injection of PV-10 in subjects with either (a) hepatocellular carcinoma (HCC) that is not amenable to resection, transplant or other potentially curative therapy or (b) cancer metastatic to the liver.

Detailed description

Subject will be enrolled in one of four planned cohorts (Main Study Group, Expansion Cohort 1, Expansion Cohort 2 or Expansion Cohort 3). Main Study Group. Three initial subjects with either HCC or cancer metastatic to the liver will receive 0.25 mL PV-10 per cc lesion volume (Lv) to a single lesion (up to a maximum dose of 7.5 mL PV-10). If none of the initial three subjects experiences a new and persistent CTCAE Grade 3 or greater non-hematological or any Grade 4 hematological toxicity over a 28-day follow-up interval, an additional three subjects will be enrolled and similarly treated with PV-10 administered at 0.50 mL per cc Lv (up to a maximum dose of 15 mL PV-10) provided no new and persistent Grade 3 or greater non-hematological or any Grade 4 hematological toxicity occurs. Expansion Cohort 1 (EC1: PV-10 plus/minus Checkpoint Inhibition). Following demonstration of safety and tolerability in the Main Study Group, up to 48 additional subjects with cancers metastatic to the liver or with HCC will be enrolled into Expansion Cohort 1 (EC1). Subjects will be treated with PV-10 administered at 0.50 mL per cc Lv (up to a maximum dose of 15 mL PV-10). Subjects may receive injection of up to two lesions in any PV-10 treatment cycle. Enrollment will continue provided no new and persistent Grade 3 or greater non-hematological (excluding fatigue) or any Grade 4 hematological toxicity occurs. Expansion Cohort 2 (EC2: PV-10 plus Checkpoint Inhibition). Following demonstration of safety and tolerability in the Main Study Group, up to 12 additional subjects with HCC on a background of standard care checkpoint inhibition therapy (i.e., anti-PD-1 therapy) will be enrolled into Expansion Cohort 2 (EC2). Subjects will be treated with PV-10 administered at 0.50 mL per cc Lv (up to a maximum dose of 15 mL PV-10). Subjects may receive injection of up to two lesions in any PV-10 treatment cycle. Enrollment will continue provided no new and persistent Grade 3 or greater non-hematological (excluding fatigue) or any Grade 4 hematological toxicity occurs. Expansion Cohort 3 (EC3: PV-10 plus Checkpoint Inhibition). Following demonstration of safety and tolerability in the Main Study Group, up to 12 additional subjects with hepatic metastases of uveal melanoma (mUM) on a background of standard care checkpoint inhibition therapy (i.e., anti-CTLA-4, anti-PD-1 or combination anti-CTLA-4 and anti-PD-1 therapy) will be enrolled into Expansion Cohort 3 (EC3). Subjects will be treated with PV-10 administered at 0.50 mL per cc Lv (up to a maximum dose of 15 mL PV-10). Subjects may receive injection of up to two lesions in any PV-10 treatment cycle. Enrollment will continue provided no new and persistent Grade 3 or greater non-hematological (excluding fatigue) or any Grade 4 hematological toxicity occurs. Concomitant therapy with immune checkpoint inhibition is allowed in Expansion Cohort 1 and required in Expansion Cohort 2 and Expansion Cohort 3. This concomitant therapy must commence at least 7 days prior to initial PV-10 administration. Subjects in each Expansion Cohort one or more additional injectable tumor ≥ 1 cm in diameter will be eligible for treatment of one or more additional injectable tumor 28 days to 6 months after prior PV-10 administration provided that any prior treatments with PV-10 were well tolerated. This may be repeated until all injectable tumors ≥ 1 cm in diameter have received PV-10.

Conditions

Interventions

Type	Name	Description
DRUG	PV-10 (10% rose bengal disodium)	Subjects will receive a single injection of PV-10 to a single Target Lesion (0.25 mL PV-10 per cc lesion volume, Lv, or 0.50 mL PV-10 per cc Lv).

Timeline

Start date: 2009-10-01
Primary completion: 2022-12-01
Completion: 2023-02-01
First posted: 2009-09-30
Last updated: 2022-11-02

Locations

5 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00986661. Inclusion in this directory is not an endorsement.