Phase I Study of Oral Darinaparsin (ZIO-101-C)in Advanced Solid Tumors and Non-Hodgkin's Lymphomas
Status unconfirmed · Phase 1
Conditions studied: Advanced Cancer
In brief
The study of Dariniparsin (ZIO-101-C) in Advanced Solid Tumors and Non-Hodgkin's Lymphomas
Key facts
- Study ID
- NCT00591422
- Run by
- Alaunos Therapeutics
- People needed
- 23
- Starts
- 2007-08-01
- Expected to finish
- 2013-06-01
- Last updated by the study team
- 2012-07-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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:
- 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.
You may not qualify if…
- 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).
- 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.
Where it is running
- Study site — Ocoee, Florida, United States
- Study site — Dallas, Texas, United States
- Study site — Norfolk, Virginia, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.