A Phase-II Trial of ZIO 101 in Advanced Hepatocellular Carcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ziopharm
ClinicalTrials.gov Identifier:
NCT00423306
First received: January 16, 2007
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

The study of safety of a new organic arsenic compound in the treatment of advanced hepatocellular carcinoma


Condition Intervention Phase
HEPATOCELLULAR CARCINOMA
Drug: Darinaparsin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase-II Trial of ZIO 101 in Advanced Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Ziopharm:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival (overall and progression free) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • toxicities [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: January 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: Darinaparsin
420 mg/m2 of Darinaparsin given twice weekly for three weeks, followed by one week of rest, for up to 6 months
Other Name: ZIO-101

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. HCC diagnosed by histology or clinical evidence supported by liver mass(es) at least 2cm in the longest diameter and AFP equal to or more than 500 ng/mL in cirrhosis or chronic HBV or HCV infection27.
  2. Male or female patients ≥ 18 years of age
  3. Patients who have a life expectancy of at least 12 weeks
  4. Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST).
  5. Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 - 2 (see Appendix 4).
  6. Patients who have received local therapy, such as surgery, radiation therapy, hepatic arterial embolization, chemo-embolization, radio-frequency ablation or cryo-ablation are eligible, provided that they either have a target lesion which has not been subjected to local therapy and/or the target lesion(s) within the field of the local therapy has shown an increase of ≥ 25% in the size. Furthermore, the local therapy applied to target or non-target lesions needs to have been completed at least 8 weeks prior to study inclusion. Lesions treated with external beam radiation therapy are not acceptable as target lesions, unless they fulfil the conditions described above.
  7. No more than one prior chemotherapy based regimen is allowed. Patients can receive up to two regimes where target therapies have been used (washout)
  8. Cirrhotic status of Child-Pugh Class A or B only (Appendix 5).
  9. Adequate hepatic function at screening as assessed by the following:

    • Platelet count ≥ 60 x 109/L
    • Hemoglobin ≥ 8.5 g/dl
    • Total bilirubin ≤ 3 mg/dl
    • ALT and AST ≤ 5 x upper limit of normal
    • Serum creatinine ≤ 2.0 x the upper limit of normal
    • PT-INR ≤ 2.3 or PT ≤ 6 seconds above control
  10. Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.

Exclusion Criteria

  1. Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors [Ta, Tis and T1] or other malignancies curatively treated > 2 years prior to entry)
  2. Congestive heart failure > NYHA Class II
  3. Cardiac arrhythmias requiring anti-arrythmics (excluding beta blockers or digoxin for chronic stable atrial fibrillation) or QTc greater than 450 msec.
  4. Active coronary artery disease or cardiac ischemia
  5. Active clinically serious bacterial, viral or fungal infections (> grade 2 NCI-CTCAE, Version 3)
  6. Known history of human immunodeficiency virus (HIV) infection for less than 2 years or uncontrolled disease on antiretroviral medication
  7. Metastatic brain or meningeal tumors
  8. Patients with seizure disorder requiring medication (such as anti-epileptics)
  9. History of confusion or dementia or neurological condition that could mask a potential adverse response to the study drug (or something along these lines)
  10. History of organ allograft
  11. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  12. Known or suspected allergy to the investigational agent or any agent given in association with this trial
  13. Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
  14. Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 14 days prior to the start of study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423306

Locations
United States, Florida
Miami, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Missouri
Kansas City, Missouri, United States
United States, New York
New York, New York, United States
United States, Washington
Seattle, Washington, United States
Sponsors and Collaborators
Ziopharm
  More Information

No publications provided

Responsible Party: Ziopharm
ClinicalTrials.gov Identifier: NCT00423306     History of Changes
Other Study ID Numbers: SGL2005
Study First Received: January 16, 2007
Last Updated: November 13, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 30, 2014