Advanced CancerPhase 1NCT00591422
Phase I Study of Oral Darinaparsin (ZIO-101-C)in Advanced Solid Tumors and Non-Hodgkin's Lymphomas
A Phase 1 study testing ZIO-101-C (Darinaparsin) in people with Advanced Cancer, run by Alaunos Therapeutics at 3 sites in United States.
Trial summary
The study of Dariniparsin (ZIO-101-C) in Advanced Solid Tumors and Non-Hodgkin's Lymphomas Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- ZIO-101-C (Darinaparsin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2007to 10 Mar 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- Men and women of ≥ 18 years of age.
- ECOG performance score ≤ 2 (see Appendix 4).
- Eligible subjects with lymphomas must have measurable disease as defined by the revised International Working Group response criteria (Appendix 7)
- Life expectancy ≥ 12 weeks.
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements, to be conducted <2 weeks prior to Baseline:
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- 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
- Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee (IEC/IRB) having jurisdiction over the site.
Who cannot join
- New York Heart Association (NYHA) functional class ≥3 myocardial infarction (see Appendix 5) within 6 months.
- 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.
- Pregnant and/or lactating female. (Women of childbearing age must use effective contraception from Screening through the duration of Study participation.)
- Uncontrolled systemic infection (documented with microbiological studies).
- Metastatic brain or meningeal tumors.
- Patients with seizure disorder requiring medication (such as anti-epileptics).
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- 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.
- 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).
- Radiotherapy during study or within 3 weeks of Study entry.
- Surgery within 4 weeks of start of Study Drug.
- Investigational drug therapy outside of this trial during or within 4 weeks of Study entry.
- 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.
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of Study results.
- Any condition that is unstable or could jeopardize the safety of the patient and his/her compliance in the Study.
- Arsenic allergy.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Dallas, Texas, 75246
Study site
Norfolk, Virginia, 23502
Study site
Ocoee, Florida, 34761
About this study
Official title: Phase I Study of Oral Darinaparsin (ZIO-101-C) in Advanced Solid Tumors and Non-Hodgkin's Lymphomas
The study of Dariniparsin (ZIO-101-C) in Advanced Solid Tumors and Non-Hodgkin's Lymphomas
- Conditions
- Advanced Cancer
- Being tested
- ZIO-101-C (Darinaparsin)
- Keywords
- Arsenic, Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZIO-101-C (Darinaparsin)Drug
Also called ZIO-101-C
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Drug: ZIO-101-C (Darinaparsin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicities
Measured: 6 months
Secondary outcomes (1)
pharmacokinetics
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startAug 2007
- Primary completion10 Mar 2010
- Study completion10 Mar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaunos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Lewis, MD, PhD, Study director, Alaunos Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591422
- Sponsor's protocol ID
- SGC1001
- Status last verified
- Sep 2026
- First submitted
- 26 Dec 2007
- Last updated
- 29 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Oral Darinaparsin (ZIO-101-C) in Advanced Solid Tumors and Non-Hodgkin's Lymphomas
- ClinicalTrials.gov ID
- NCT00591422
- Acronym / sponsor ID
- SGC1001
- Conditions
- Advanced Cancer
- Keywords
- Arsenic, Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Alaunos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- 10 Mar 2010 (actual)
- Study completion
- 10 Mar 2011 (actual)
- First posted
- 11 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study of Dariniparsin (ZIO-101-C) in Advanced Solid Tumors and Non-Hodgkin's Lymphomas
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: ZIO-101-C (Darinaparsin) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
- Men and women of ≥ 18 years of age.
- ECOG performance score ≤ 2 (see Appendix 4).
- Eligible subjects with lymphomas must have measurable disease as defined by the revised International Working Group response criteria (Appendix 7)
- Life expectancy ≥ 12 weeks.
Key exclusion criteria (15 listed)
- New York Heart Association (NYHA) functional class ≥3 myocardial infarction (see Appendix 5) within 6 months.
- 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.
- Pregnant and/or lactating female. (Women of childbearing age must use effective contraception from Screening through the duration of Study participation.)
- Uncontrolled systemic infection (documented with microbiological studies).
- Metastatic brain or meningeal tumors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZIO-101-C (Darinaparsin)Also: ZIO-101-CCapsule, 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. | Drug | Single Arm |
Primary outcome
Toxicities
Time frame: 6 months
1 secondary outcome
pharmacokinetics
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Lewis, MD, PhD study director
Alaunos Therapeutics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZIO-101-C (Darinaparsin) in people with Advanced Cancer, run by Alaunos Therapeutics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicities (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.