Phase I Study of Oral ZIO-101-C in Advanced Solid Tumors and Lymphomas
- Conditions
- Advanced Solid TumorsLymphomas
- Interventions
- Drug: ZIO-101-C (Darinaparsin)
- Registration Number
- NCT00592163
- Lead Sponsor
- Alaunos Therapeutics
- Brief Summary
A Phase I Study of Oral ZIO-101-C in Advanced Solid Tumors and Lymphomas
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
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Subjects with histological or cytological confirmation of advanced cancer that is refractory to standard therapies for their condition.
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Men and women of ≥18 years of age.
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ECOG performance score ≤2.
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Eligible subjects MUST have at least one measurable lesion as defined by RECIST guidelines. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology. Measurable lesions MUST NOT have been in a previously irradiated field or injected with biological agents. Eligible subjects with lymphomas must have measurable disease as defined by the revised International Working Group response criteria.
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Life expectancy ≥12 weeks.
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Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements, to be conducted <2 weeks prior to Baseline:
- Creatinine ≤1.5 × upper limit of normal (ULN) OR a calculated creatinine clearance ≥50 cc/min
- Total bilirubin ≤2 × ULN
- Alanine transaminase (ALT) and aspartate transaminase (AST) ≤3 × ULN
- Granulocytes in peripheral blood ≥1 × 109/L, hemoglobin ≥10 g/dL, and platelets ≥50,000 /μL
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Adequate vascular access for repeated blood sampling.
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Men and women of childbearing potential must agree to use effective contraception from Screening through the duration of Study participation.
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Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee (IEC/IRB) having jurisdiction over the site.
- New York Heart Association (NYHA) functional class ≥3 myocardial infarction 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 women.
- Uncontrolled systemic infection (documented with microbiological studies).
- Metastatic brain or meningeal tumors.
- Subjects 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 the 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 dosing.
- 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 subject's participation in the study or evaluation of Study results.
- Any condition that is unstable or could jeopardize the safety of the subject and his/her compliance in the Study.
- Arsenic allergy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm ZIO-101-C (Darinaparsin) -
- Primary Outcome Measures
Name Time Method toxicities 6 months
- Secondary Outcome Measures
Name Time Method pharmacokinetics 6 months