Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow Cancers
NCT ID: NCT00421213
Last Updated: 2012-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2006-12-31
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
Darinaparsin
300mg/m2 of Darinaparsin given daily for five consecutive days to be repeated every 28 days for up to six months.
Interventions
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Darinaparsin
300mg/m2 of Darinaparsin given daily for five consecutive days to be repeated every 28 days for up to six months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. ≥ 1 prior therapy and currently requiring therapy.
3. Evaluable disease (defined by disease-specific criteria listed in Appendix 1)
4. ≥ 18 years of age.
5. ECOG performance score ≤ 2 (see Appendix 2).
6. Life-expectancy ≥ 2 months.
7. Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee with jurisdiction over the site.
8. No anti-cancer therapy exception of hydroxyurea ≤ 3 weeks before Baseline (Day 1, Cycle 1).
9. 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.
Exclusion Criteria
2. Pregnant and/or lactating female. (Women of childbearing age must use effective contraception from Screening through the duration of study participation).
3. Uncontrolled infection.
4. Prior seizures ≥ grade-3 in CTC v.3 criteria.
5. Arsenic allergy.
6. Significant neuropathology, defined as grade \> 2 per CTCAE Version 3.0.
7. Confusion or dementia.
8. Prior history of neurological deficits (e.g., stroke, dementia, ischemia) that has the potential to confound a post-dose neurological assessment.
18 Years
ALL
No
Sponsors
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Alaunos Therapeutics
INDUSTRY
Responsible Party
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Locations
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Miami, Florida, United States
Chicago, Illinois, United States
Bethesda, Maryland, United States
Fargo, North Dakota, United States
Sioux Falls, South Dakota, United States
Morgantown, West Virginia, United States
Countries
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Other Identifiers
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SGL2003
Identifier Type: -
Identifier Source: org_study_id