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

  • STATUS
    Recruiting
  • End date
    Feb 24, 2022
  • participants needed
    78
  • sponsor
    Provectus Biopharmaceuticals, Inc.
Updated on 24 March 2021
platelet count
renal function
cancer
measurable disease
carcinoma
tumor growth
karnofsky performance status
kidney function tests
EGFR
spiral computed tomography
biliary tract cancer
renal function test

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.

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.

Details
Condition Adenocarcinoma, Therapeutic procedure, HEPATIC NEOPLASM, treatment, HEPATOCELLULAR CARCINOMA, Metastatic Melanoma, Metastatic Colorectal Cancer, Metastatic Breast Cancer, Metastatic Pancreatic Cancer, Cancer Metastatic to the Liver, Hepatocellular Carcinoma That is Not Amenable to Resection, Transplant or Other Potentially Curative, Stage IV Breast Cancer, Stage IV Melanoma, Lung Metastasis, Metastatic Lung Cancer, Lung Metastases, Metastatic Colon Cancer, Metastatic Uveal Melanoma, Hepatocellular Carcinoma That is Not Amenable to Resection, Transplant or Other Potentially Curative, Metastatic Ocular Melanoma, Liver Cancer, Malignant Adenoma, Pulmonary Metastasis, liver cell carcinoma
Treatment PV-10 (10% rose bengal disodium)
Clinical Study IdentifierNCT00986661
SponsorProvectus Biopharmaceuticals, Inc.
Last Modified on24 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: treatment or HEPATOCELLULAR CARCINOMA or Metastatic Breast Cancer or Metastatic Colon Cancer or HEPATIC NEOPLASM or Therapeutic procedure or Liver Can...?
Do you have any of these conditions: Pulmonary Metastasis or Metastatic Breast Cancer or HEPATIC NEOPLASM or Therapeutic procedure or Stage IV Breast Cancer or Metastatic Colon Cancer or ...?
Do you have any of these conditions: treatment or Metastatic Melanoma or Liver Cancer or Lung Metastases or Metastatic Colon Cancer or Stage IV Melanoma or Malignant Adenoma or Pulmonary ...?
Do you have any of these conditions: Liver Cancer or Lung Metastasis or Metastatic Pancreatic Cancer or Cancer Metastatic to the Liver or treatment or Metastatic Colorectal Cancer or Meta...?
Age 18 years or older, males and females
Histologically or cytologically confirmed, or clinically diagnosed based on currently accepted standards, cancer metastatic to the liver or HCC that is not amenable at the time of enrollment to resection, transplant or other potentially curative therapy
At least one Target Lesion determined to be amenable to percutaneous injection by the treating physician
Target Lesion(s) must have measurable disease, defined as a unidimensionally measurable lesion 1.0 cm in longest diameter by helical CT; the maximum diameter of Target Lesion(s) shall be 4.9 cm
Performance status of Karnofsky scale 60%-100% or ECOG performance scale 0-2
Life expectancy 12 weeks
Hematopoietic Function: WBC 2,500/mm3; ANC 1000/mm3; Hemoglobin 8 g/dL; Platelet count 50,000/mm3; Coagulation: INR 1.3
AST and ALT < 5 times ULN; ALP < 5 times ULN; Bilirubin 1.5 times ULN; Creatinine 1.5 times ULN and eGFR 50
Thyroid Function: Total T3 or free T3, total T4 or free T4 and THS CTCAE Grade 2 abnormality
Renal Function: Adequate renal function in the opinion of the Investigator with no clinically significant renal impairment or uncontrolled renal disease
Cardiovascular Function: Adequate cardiovascular function in the opinion of the Investigator with no clinically significant uncontrolled cardiovascular disease
Respiratory Function: Adequate respiratory function in the opinion of the Investigator with no clinically significant uncontrolled respiratory disease
Immunological Function: Adequate immune system function in the opinion of the Investigator with no known immunodeficiency disease
Informed Consent: Signed by the subject prior to screening

Exclusion Criteria

Target Lesion(s) must not be contiguous with, encompass or infiltrate major blood vessels
Primary HCC amenable to resection, transplant or other potentially curative therapy
Surgery: Subjects who have received hepatic surgery, ablation or chemoembolization within 4 weeks of PV-10 administration
Radiation Therapy: Hepatic radiation within 4 weeks of PV-10 administration
Chemotherapy: Chemotherapy within 4 weeks of PV-10 administration (6 weeks for nitrosoureas or mitomycin C)
Investigational Agents: Investigational agents within 4 weeks (or 5 half-lives) of PV-10 administration
Phototoxic or Photosensitizing Agents: Concomitant agents posing a clinically significant risk of photosensitivity reaction within 5 half-lives of PV-10 administration
Concurrent or Intercurrent Illness: Impaired wound healing due to diabetes; Significant concurrent or intercurrent illness, psychiatric disorders or alcohol or chemical dependence that would compromise Subject safety or compliance or interfere with interpretation of the study; Uncontrolled thyroid disease or cystic fibrosis; Presence of clinically significant acute or unstable cardiovascular, cerebrovascular (stroke), renal, gastrointestinal, pulmonary, immunological (with the exception of the presence of hepatitis B virus (HBV), viral hepatitis, or cirrhosis), endocrine, or central nervous system disorders; Current encephalopathy or current treatment for encephalopathy; Variceal bleeding requiring hospitalization or transfusion within 4 months of screening; History of human immunodeficiency virus or acquired immune deficiency syndrome; The clinical presence of ascites
Pregnancy: Female subjects who are pregnant, lactating or have positive serum HCG pregnancy test taken within 7 days of PV-10 administration; Fertile subjects who are not using effective contraception (e.g., oral contraceptives, intrauterine devices, double barrier methods such as condoms and diaphragms, abstinence or equivalent measures)
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