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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

ZIOPHARM

ClinicalTrials.gov Identifier:

NCT00421213

First received: January 10, 2007

Last updated: July 18, 2012

Last verified: July 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 10, 2007
Last Updated Date	July 18, 2012
Start Date ^ICMJE	December 2006
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 3, 2008)	Response Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00421213 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 3, 2008)	toxicities [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow Cancers
Official Title ^ICMJE	Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow Cancers
Brief Summary	The study of safety of a new organic arsenic compound in the treatment of hematological malignancies.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Hematologic Neoplasms Bone Marrow Neoplasms Non-Hodgkin's Lymphoma
Intervention ^ICMJE	Drug: Darinaparsin 300mg/m2 of Darinaparsin given daily for five consecutive days to be repeated every 28 days for up to six months. Other Name: ZIO-101
Study Arm (s)	Experimental: Single Arm Intervention: Drug: Darinaparsin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	50
Completion Date	April 2012
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00421213
Other Study ID Numbers ^ICMJE	SGL2003
Has Data Monitoring Committee	Not Provided
Responsible Party	ZIOPHARM
Study Sponsor ^ICMJE	ZIOPHARM
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	ZIOPHARM
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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