Status:
COMPLETED
Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow Cancers
Lead Sponsor:
Alaunos Therapeutics
Conditions:
Hematologic Neoplasms
Bone Marrow Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The study of safety of a new organic arsenic compound in the treatment of hematological malignancies.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00421213
Start Date
December 1 2006
End Date
April 1 2012
Last Update
July 19 2012
Active Locations (6)
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1
Miami, Florida, United States
2
Chicago, Illinois, United States
3
Bethesda, Maryland, United States
4
Fargo, North Dakota, United States