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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00421213
First Posted: January 11, 2007
Last Update Posted: July 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ziopharm
  Purpose
The study of safety of a new organic arsenic compound in the treatment of hematological malignancies.

Condition Intervention Phase
Hematologic Neoplasms Bone Marrow Neoplasms Non-Hodgkin's Lymphoma Drug: Darinaparsin Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow Cancers

Resource links provided by NLM:


Further study details as provided by Ziopharm:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • toxicities [ Time Frame: 6 months ]

Enrollment: 50
Study Start Date: December 2006
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm 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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00421213


Locations
United States, Florida
Miami, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Maryland
Bethesda, Maryland, United States
United States, North Dakota
Fargo, North Dakota, United States
United States, South Dakota
Sioux Falls, South Dakota, United States
United States, West Virginia
Morgantown, West Virginia, United States
Sponsors and Collaborators
Ziopharm
  More Information

Responsible Party: Ziopharm
ClinicalTrials.gov Identifier: NCT00421213     History of Changes
Other Study ID Numbers: SGL2003
First Submitted: January 10, 2007
First Posted: January 11, 2007
Last Update Posted: July 19, 2012
Last Verified: July 2012

Keywords provided by Ziopharm:
APL
Lymphoma
T-cell Lymphoma
Peripheral T-cell Lymphoma

Additional relevant MeSH terms:
Lymphoma
Neoplasms
Lymphoma, Non-Hodgkin
Hematologic Neoplasms
Bone Marrow Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Hematologic Diseases
Bone Marrow Diseases