Clinical trial · Interventional
Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow Cancers
NCT00421213CI-TRIAL-00007508completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
The study of safety of a new organic arsenic compound in the treatment of hematological malignancies.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Marrow Neoplasms | Bone Marrow Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Darinaparsin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- interventionNames
- Drug: Darinaparsin
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- 6 months
Secondary outcomes (1)
- measure
- toxicities
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.