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CompletedNCT00591422Updated Sep 29, 2026

Phase I Study of Oral Darinaparsin (ZIO-101-C)in Advanced Solid Tumors and Non-Hodgkin's Lymphomas

A Phase 1 interventional study of ZIO-101-C (Darinaparsin) in Advanced Cancer, sponsored by Alaunos Therapeutics. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Alaunos Therapeutics · Phase 1, Interventional, and Treatment

Updated Sep 29, 2026Now CompletedPrimary completion moved+1 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The study of Dariniparsin (ZIO-101-C) in Advanced Solid Tumors and Non-Hodgkin's Lymphomas

02

Conditions studied

  • Advanced Cancer

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Keywords

  • Arsenic
  • Cancer
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 23 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

Alaunos Therapeutics is the lead sponsor of 37 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients with non-Hodgkin's Lymphomas that are refractory to standard therapies for their condition.(As of protocol amendment 6.0 dated 8/26/2009)
  2. Men and women of ≥ 18 years of age.
  3. ECOG performance score ≤ 2 (see Appendix 4).
  4. Eligible subjects with lymphomas must have measurable disease as defined by the revised International Working Group response criteria (Appendix 7)
  5. Life expectancy ≥ 12 weeks.
  6. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements, to be conducted \<2 weeks prior to Baseline:

    • Creatinine ≤ 2X upper limit of normal (ULN) OR a calculated creatinine clearance ≥ 50 cc/min
    • Total bilirubin ≤ 2X ULN
    • Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3X ULN
    • Granulocytes in peripheral blood ≥1 x 109/L, hemoglobin ≥8.5 g/dL, and platelets ≥50,000 /µL
  7. Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee (IEC/IRB) having jurisdiction over the site.

Exclusion criteria

Exclusion Criteria

  1. New York Heart Association (NYHA) functional class ≥3 myocardial infarction (see Appendix 5) within 6 months.
  2. 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); or documented history of prolonged QTc.
  3. Pregnant and/or lactating female. (Women of childbearing age must use effective contraception from Screening through the duration of Study participation.)
  4. Uncontrolled systemic infection (documented with microbiological studies).
  5. Metastatic brain or meningeal tumors.
  6. Patients with seizure disorder requiring medication (such as anti-epileptics).
  7. History of confusion or dementia or neurological condition that could mask a potential adverse response to Study Drug which may include transient ischemic attack, Parkinson's disease, thrombotic or hemorrhagic stroke, Alzheimers, and other neurological disorders.
  8. Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of Study entry (mitomycin C or nitrosureas should not be given within 6 weeks of Study entry).
  9. Radiotherapy during study or within 3 weeks of Study entry.
  10. Surgery within 4 weeks of start of Study Drug.
  11. Investigational drug therapy outside of this trial during or within 4 weeks of Study entry.
  12. History of invasive second primary malignancy diagnosed within the previous 3 years except for Stage I endometrial/cervical carcinoma or prostate carcinoma treated surgically, and non-melanoma skin cancer.
  13. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of Study results.
  14. Any condition that is unstable or could jeopardize the safety of the patient and his/her compliance in the Study.
  15. Arsenic allergy.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Single Arm

    Drug: ZIO-101-C (Darinaparsin)

Interventions

  • DrugZIO-101-C (Darinaparsin)

    Capsule, Dose escalation study from 100 mg to 1000 mg (or Maximum Tolerated Dose). 3 times weekly (\>36 hours between doses) for 3 weeks with 1 week rest.

    Also known as: ZIO-101-C

06

What researchers measure

Primary outcomes

  1. Toxicities

    Time frame: 6 months

Secondary outcomes

  1. pharmacokinetics

    Time frame: 6 months

07

Study locations

3 sites
  • Ocoee, Florida 34761, United States
  • Dallas, Texas 75246, United States
  • Norfolk, Virginia 23502, United States
08

Updates

1 registry update since Sep 25, 2026
Status
Status unknown→Completed
changed Sep 29, 2026
Primary completion
Jun 2013→Mar 10, 2010 (actual)
Sep 29, 2026
Study completion
Jun 2013→Mar 10, 2011 (actual)
Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    Status unknown→Completed
    Primary completion Jun 2013→Mar 10, 2010 (now actual)
    Study completion Jun 2013→Mar 10, 2011 (now actual)
    + 2 other changes: verification date and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT00591422
Lead sponsor
Alaunos Therapeutics
Responsible party
Sponsor
First posted
Jan 11, 2008
Start date
Aug 2007
Primary completion
Mar 10, 2010
Completion
Mar 10, 2011
Last update
Sep 29, 2026

Study contacts

Jonathan Lewis, MD, PhD
study director · Alaunos Therapeutics
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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