Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow Cancers

Completed · Phase 2

Conditions studied: Hematologic Neoplasms, Bone Marrow Neoplasms, Non-Hodgkin's Lymphoma

In brief

The study of safety of a new organic arsenic compound in the treatment of hematological malignancies.

Key facts

Study ID

NCT00421213

Run by

Alaunos Therapeutics

People needed

50

Starts

2006-12-01

Expected to finish

2012-04-01

Last updated by the study team

2012-07-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Study site — Miami, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Bethesda, Maryland, United States
• Study site — Fargo, North Dakota, United States
• Study site — Sioux Falls, South Dakota, United States
• Study site — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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