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

January 10, 2007
July 18, 2012
December 2006
April 2012   (final data collection date for primary outcome measure)
Response Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00421213 on ClinicalTrials.gov Archive Site
toxicities [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow Cancers
Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow Cancers

The study of safety of a new organic arsenic compound in the treatment of hematological malignancies.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hematologic Neoplasms
  • Bone Marrow Neoplasms
  • Non-Hodgkin's Lymphoma
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
Experimental: Single Arm
Intervention: Drug: Darinaparsin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
April 2012
April 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00421213
SGL2003
Not Provided
Ziopharm
Ziopharm
Not Provided
Not Provided
Ziopharm
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP