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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • toxicities [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ziopharm
ClinicalTrials.gov Identifier: NCT00421213     History of Changes
Other Study ID Numbers: SGL2003
Study First Received: January 10, 2007
Last Updated: July 18, 2012
Health Authority: United States: Food and Drug Administration
India: DCGI

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

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

ClinicalTrials.gov processed this record on July 24, 2014