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

Study Overview
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Brief Summary
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The study of safety of a new organic arsenic compound in the treatment of hematological malignancies.

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

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

Intervention / Treatment
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* Drug: Darinaparsin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 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. Exclusion Criteria 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br> | Drug: Darinaparsin<br>* 300mg/m2 of Darinaparsin given daily for five consecutive days to be repeated every 28 days for up to six months.<br>* Other names: ZIO-101;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicities |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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APL, Lymphoma, T-cell Lymphoma, Peripheral T-cell Lymphoma