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

NCT00421213 | Terminated Phase 2

• 1 other identifier: SGL2003
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Hematologic Neoplasms; Bone Marrow Neoplasms; Non-Hodgkin's Lymphoma

Keywords

APL; Lymphoma; T-cell Lymphoma; Peripheral T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Response Rate

  6 months

Secondary Outcomes (1)

• toxicities

  6 months

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: Darinaparsin

Interventions

Darinaparsin DRUG

300mg/m2 of Darinaparsin given daily for five consecutive days to be repeated every 28 days for up to six months.

Also known as: ZIO-101

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alaunos Therapeutics: lead

Study Sites (6)

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Bethesda, Maryland, United States

Location

Unknown Facility

Fargo, North Dakota, United States

Location

Unknown Facility

Sioux Falls, South Dakota, United States

Location

Unknown Facility

Morgantown, West Virginia, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Bone Marrow Neoplasms; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral

Interventions

darinaparsin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2007
• First Posted: January 11, 2007
• Study Start: December 29, 2006
• Primary Completion: June 30, 2009
• Study Completion: June 30, 2009
• Last Updated: October 1, 2026

Record last verified: 2026-09

Locations

US (6)