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Summary

for people ages 20–80 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

This phase 1 study is to determine the optimal dose and tolerability of a hypoxia-activating agent, tirapazamine, when it is combined with embolization in liver cancer. Liver cancer patients who are Child-Pugh score A, suitable for embolization with tumor no more than 4 nodules are eligible. Tirapazamine will be given by intra-arterial injection before embolization. Treatment effect is evaluated by MRI based on mRECIST criteria. Repeat treatment is necessary only if disease progression. Expansion cohorts are open for metastatic gastrointestinal cancer and neuroendocrine tumor.

Official Title

Phase I Dose-Escalating Study of Combining Intravenous Tirapazamine and Transarterial Embolization (TAE) in Liver Cancer

Details

The study is a 3+3 design for dose escalation. Each cohort will have 3-6 patients based on tolerability. Patients will receive escalated doses of tirapazamine until maximally tolerated dose. Embolization is performed per standard practice using Lipiodol and Gelfoam under X-ray guidance. Once a suitable dose is determined, an expansion cohort of 15 patients will be treated with the recommended phase 2 dose to determine preliminary efficacy. Expansion cohorts include one for hepatocellular carcinoma and one for metastatic gastrointestinal cancer, including neuroendocrine tumor. Adverse events are evaluated by CTCAE vs. 4.0 and efficacy is evaluated by MRI using modified RECIST criteria.

Keywords

Hepatocellular Carcinoma Gastrointestinal Cancer Metastatic Neuroendocrine Tumors Hypoxia Embolization Tirapazamine Carcinoma, Hepatocellular Liver Neoplasms Carcinoid Tumor Gastrointestinal Neoplasms Ethiodized Oil Gelatin Sponge, Absorbable

Eligibility

For people ages 20–80

  • Confirmed diagnosis of HCC > 10 mm with a characteristic 4-phase CT or dynamic contrast enhanced MRI finding showing intense arterial uptake followed by "washout" of contrast in the venous-delayed phases per American Association for the Study of Liver Disease (AASLD) criteria.
  • Patients between ages 20 and 80
  • Patients with single or multiple (2-4 nodules) HCC who are unsuitable or unwilling for surgical resection or RFA. The largest tumor nodule should be less than 10 cm in the largest diameter. The total volume of tumor cannot exceed 50% of liver; or patients with liver metastatic gastrointestinal cancer, including neuroendocrine tumor
  • Patients are candidates for TAE or Transarterial ChemoEmbolization (TACE). No tumor invasion to portal vein or thrombosis in portal vein.
  • ECOG score 0-1 with no known cardiac, pulmonary or renal dysfunction
  • Child-Pugh score group A or B7 liver functional score
  • Prior local therapies such as surgical resection, radiofrequency ablation, or alcohol injection are allowed as long as tumor progresses from the prior treatment and the patients are still candidates for TAE. All prior therapy must be at least 4 weeks prior to enrollment and free from treatment-related toxicity.
  • No TAE/TACE in the past
  • Patients have normal organ function: ANC ≥ 1000 /µL, Hemoglobin ≥ 9 gm/dL, Platelets ≥50,000 /µL, Creatinine ≤ 2 mg/dL, AST and ALT < 5 X upper normal limit of the current institution; bilirubin ≤ 3.0 mg/dL, PT prolongation no more than 4 sec above upper limit of normal.

For the expansion cohort of neuroendocrine tumor or metastatic gastrointestinal cancer

  • Unresectable, locally advanced or metastatic, well differentiated (low or intermediate grade), neuroendocrine tumors (NET).
  • Liver metastatic gastrointestinal cancer.

Locations

  • Univ. of California, San Francisco accepting new patients
    San Francisco, California, 94143, United States
  • University of California Irvine Medical Center accepting new patients
    Orange, California, 92868, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Teclison Ltd.
ID
NCT02174549
Phase
Phase 1
Lead Scientist
Nicholas Fidelman
Study Type
Interventional
Last Updated
November 13, 2017
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