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

Phase 2
18 Years
Not Enrolling
Hematologic Neoplasms, Bone Marrow Neoplasms, Non-Hodgkin's Lymphoma

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Trial Information

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

Inclusion Criteria

Inclusion Criteria

1. Hodgkin's or non-Hodgkin's Lymphoma.

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

1. 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).

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate

Outcome Time Frame:

6 months

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2006

Completion Date:

April 2012

Related Keywords:

  • Hematologic Neoplasms
  • Bone Marrow Neoplasms
  • Non-Hodgkin's Lymphoma
  • APL
  • Lymphoma
  • T-cell Lymphoma
  • Peripheral T-cell Lymphoma
  • Neoplasms
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Bone Marrow Neoplasms
  • Hematologic Neoplasms



Hinsdale, Illinois  60521
Miami, Florida  33176
Baltimore, Maryland  21287
Charleston, West Virginia  25304
Sioux Falls, South Dakota  
Bismarck, North Dakota  58501