Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow Cancers
1 other identifier
interventional
50
1 country
6
Brief Summary
The study of safety of a new organic arsenic compound in the treatment of hematological malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2006
Longer than P75 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 10, 2007
CompletedFirst Posted
Study publicly available on registry
January 11, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedJuly 19, 2012
July 1, 2012
5.3 years
January 10, 2007
July 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response Rate
6 months
Secondary Outcomes (1)
toxicities
6 months
Study Arms (1)
Single Arm
EXPERIMENTALInterventions
300mg/m2 of Darinaparsin given daily for five consecutive days to be repeated every 28 days for up to six months.
Eligibility Criteria
You may qualify if:
- Hodgkin's or non-Hodgkin's Lymphoma.
- ≥ 1 prior therapy and currently requiring therapy.
- Evaluable disease (defined by disease-specific criteria listed in Appendix 1)
- ≥ 18 years of age.
- ECOG performance score ≤ 2 (see Appendix 2).
- Life-expectancy ≥ 2 months.
- Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee with jurisdiction over the site.
- No anti-cancer therapy exception of hydroxyurea ≤ 3 weeks before Baseline (Day 1, Cycle 1).
- The following clinical laboratory values \< 2 weeks before Baseline:
- Creatinine ≤ 2X upper limit of normal (ULN).
- Total bilirubin ≤ 2X ULN.
- Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3X ULN.
You may not qualify if:
- New York Heart Association (NYHA) functional class ≥3 myocardial infarction (see Appendix ) within 6 months before Baseline or uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation; a QTc ≥450 msec; or a ≥grade-2 atrioventricular (AV) block or left bundle branch block (LBBB).
- Pregnant and/or lactating female. (Women of childbearing age must use effective contraception from Screening through the duration of study participation).
- Uncontrolled infection.
- Prior seizures ≥ grade-3 in CTC v.3 criteria.
- Arsenic allergy.
- Significant neuropathology, defined as grade \> 2 per CTCAE Version 3.0.
- Confusion or dementia.
- Prior history of neurological deficits (e.g., stroke, dementia, ischemia) that has the potential to confound a post-dose neurological assessment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Unknown Facility
Miami, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Bethesda, Maryland, United States
Unknown Facility
Fargo, North Dakota, United States
Unknown Facility
Sioux Falls, South Dakota, United States
Unknown Facility
Morgantown, West Virginia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2007
First Posted
January 11, 2007
Study Start
December 1, 2006
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
July 19, 2012
Record last verified: 2012-07