Know Cancer

or
forgot password

A Phase 1/2 Open-Label Study to Evaluate Safety and Preliminary Evidence of Effectiveness of Tumor Ablation With Talaporfin Sodium (LS11) and Interstitial Light Emitting Diodes (LEDs) in the Treatment of Subjects With Inoperable Hepatocellular Carcinoma (HCC)


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Hepatocellular, Liver Neoplasms

Thank you

Trial Information

A Phase 1/2 Open-Label Study to Evaluate Safety and Preliminary Evidence of Effectiveness of Tumor Ablation With Talaporfin Sodium (LS11) and Interstitial Light Emitting Diodes (LEDs) in the Treatment of Subjects With Inoperable Hepatocellular Carcinoma (HCC)


Subjects that provide Informed Consent and satisfy the Eligibility Criteria will undergo CT
or Ultrasound guided percutaneous placement of a single, two, three, or four Light Sources
depending on their tumor characteristics. No more than four Light Sources will be used at a
single treatment session. The Light Sources may be used in a single lesion or in multiple
lesions. Depending on lesion size, one or more Light Sources may be used to treat a single
lesion.

Following ultrasound or CT confirmation of the Light Sources, patients will receive an
intravenous dose of LS11 at 1 mg/kg. 15 minutes to 1 hour following completion of LS11
administration, delivery of 200 J/cm light energy at 20 mW/cm will begin. Upon completion of
light treatment, the Light Sources will then be manually removed and the patients will be
observed for acute complications.

Subjects will be evaluated for treatment-related adverse events at every scheduled clinical
visit. Restaging by contrast enhanced spiral CT and tumor evaluation, using the RECIST
criteria, are performed at Week 4 and Week 8.

Subjects may receive a second Litx™ treatment at Week 4 or Week 8, as recommended by the
study investigator. Subjects who receive the second Litx™ treatment will be evaluated for
treatment-related adverse events at every scheduled clinical visit. Restaging by contrast
enhanced spiral CT and tumor evaluation, using the RECIST criteria, are performed. The
active phase of the protocol ends 8 weeks after the last treatment received.

Following completion of the active phase of the protocol, subjects will be monitored for
survival for one year (at 6, 9 and 12 month time points) from the date of study entry or
until death, whichever occurs first.


Inclusion Criteria:



- A diagnosis of primary Hepatocellular Carcinoma (HCC), established by any one of the
following criteria in a clinical setting suggestive of HCC: (i) Two different imaging
techniques that suggests HCC; (ii) Combination of one imaging technique that suggests
HCC and serum alpha-fetoprotein (AFP) level >400 ng/mL; (iii) Histological evidence
of HCC;

- Subjects with at least 1 but no more than 3 lesions in the liver may be considered
for enrollment in the study;

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2;

- Life expectancy of at least 16 weeks;

- Prior treatment failure with locally ablative techniques is allowed. Subjects who
were not candidates for surgery, systemic chemotherapy, chemoembolization (TACE),
intratumoral ethanol injection (PEI), radiofrequency ablation (RFA), cryoablation or
other locally ablative technology may be eligible, but at least 4 weeks must have
elapsed since the completion of any prior therapy and the subject must have recovered
from acute side effects;

- Understanding and ability to sign written informed consent;

- 18 years of age or more;

- Adequate hematologic, liver and renal functions as evidenced by the following: *WBC >
2,400/mm; *Platelet Count > 75,000/µl; *Hemoglobin > 9.4 gm/dL; *PT and PTT < 1.5
Control; *AST, ALT < 5 x ULN; *Bilirubin < 1.5 X ULN; *Alk Phos < 3X ULN; *Creatinine
< 2.5 mg/dL (SI: 221 mmol/L)

Exclusion Criteria:

- Subjects who are candidates for surgery with curative intent;

- Subjects with lesions larger than 8 cm in diameter and more than 40% of parenchymal
disease involvement;

- Known sensitivity to porphyrin type drugs;

- Known history of porphyria;

- Known presence of extrahepatic metastases;

- Anticipated need for systemic chemotherapy during the first 8 weeks of the study;

- Child-Pugh C cirrhosis;

- Diffuse HCC;

- Concurrent participation in another clinical trial involving experimental treatment;

- Any concurrent disease or condition that in the opinion of the investigator impairs
the subject's ability to complete the trial. Psychological, familial, sociological,
geographical or medical conditions which in the Principal Investigator's opinion
could compromise compliance with the objectives and procedures of this protocol or
obscure interpretation of the trial's data.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Principal Investigator

Sy-Shi Wang, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Light Sciences Oncology

Authority:

Hong Kong: Department of Health

Study ID:

LSC-OL004

NCT ID:

NCT00122876

Start Date:

April 2005

Completion Date:

October 2006

Related Keywords:

  • Carcinoma, Hepatocellular
  • Liver Neoplasms
  • Hepatocellular Carcinoma
  • HCC
  • Photodynamic therapy
  • Talaporfin Sodium (LS11)
  • Light emitting diodes (LEDs)
  • Litx
  • Light Infusion Technology
  • Neoplasms
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location