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A Study to Assess PV-10 Chemoablation of Cancer of the Liver
This study is ongoing, but not recruiting participants.

First Received on September 24, 2009.   Last Updated on March 16, 2011   History of Changes
Sponsor: Provectus Pharmaceuticals
Information provided by: Provectus Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00986661
  Purpose

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 recurrent hepatocellular carcinoma (HCC) or cancer metastatic to the liver. In each of two planned dose cohorts there will be three subjects. Dose escalation will occur following assessment of safety and tolerability in the first cohort.


Condition Intervention Phase
Cancer Metastatic to the Liver
Hepatoma Recurrent
Drug: PV-10 (10% rose bengal disodium)
Phase I

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of PV-10 Chemoablation of Cancer Metastatic to the Liver or Recurrent Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Provectus Pharmaceuticals:

Primary Outcome Measures:
  • Safety. Systemic and locoregional Adverse Events (AEs) will be graded by CTCAE v3.0 and coded according to MedDRA. AE data for all subjects in the 1st cohort will be assessed prior to dose escalation. Final assessment use AE data for all subjects. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Lesion distribution and retention of PV-10 following injection. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Objective response rate (ORR) of Target and measurable Bystander Lesions (if present) by modified RECIST. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Changes in markers of hepatic function, including ALP, ALT, AST, total bilirubin and GGT. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics of PV-10 in the bloodstream following intralesional injection. Samples will be obtained immediately prior to PV-10 injection and at 2, 4, 8, 24 and 72 hours, and 7, 14 and 28 days to assess uptake and excretion of PV-10. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 6
Study Start Date: October 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PV-10 Injection (Intralesional)
Two cohorts of three subjects each will receive a single dose of PV-10 to one Target Lesion.
Drug: PV-10 (10% rose bengal disodium)
The initial three subjects will receive a single injection of PV-10 to a single Target Lesion (0.25 mL PV-10 per cc lesion volume, Lv). If none of the initial three subjects experiences a new and persistent Grade 3 non-hematological or any Grade 4 hematological toxicity over a 28-day follow-up interval, an additional three subjects may be enrolled and similarly treated with PV-10 administered at 0.50 mL per cc Lv.

  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, males and females.
  • Histologically or cytologically confirmed cancer metastatic to the liver or recurrent HCC.
  • The Target Lesion must be determined to be amenable to percutaneous injection by the treating physician.
  • The Target Lesion must have measurable disease, defined as a unidimensionally measurable lesion ≥ 1.0 cm in longest diameter by helical CT.
  • The Target Lesion must be ≤ 3.8 cm in longest diameter (e.g., ≤ 30 cm3 in volume).
  • 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 within normal limits (WNL).
  • 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:

  • Primary Resectable HCC
  • 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: Uncontrolled 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; Thyroid disease (subclinical or ongoing), goiter, partial thyroidectomy, previous radioiodine or surgically treated Graves' hyperthyroidism or cystic fibrosis, or taking thyroid hormone medication; 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; A documented variceal hemorrhage 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 β HCG pregnancy test taken within 7 days of PV-10 administration; Fertile subjects who are not using effective contraception.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00986661

Locations
United States, California
Sharp Memorial Hospital
San Diego, California, United States, 92123
Sponsors and Collaborators
Provectus Pharmaceuticals
Investigators
Study Director: Eric Wachter, Ph.D. Provectus Pharmaceuticals
Principal Investigator: Paul M Goldfarb, M.D. Sharp Clinical Oncology Research
  More Information

No publications provided

Responsible Party: Eric Wachter, Ph.D., Study Director, Provectus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00986661     History of Changes
Other Study ID Numbers: PV-10-LC-01
Study First Received: September 24, 2009
Last Updated: March 16, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Liver Neoplasms
Carcinoma, Hepatocellular
Neoplasms
Neoplasms, Second Primary
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on February 09, 2012