Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2005-07-31
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
ZIO-101 (Darinaparsin)
Dose Escalation of ZIO-101 (Darinaparsin) given daily for five consecutive days to be repeated every 28 days for up to six months
Interventions
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ZIO-101 (Darinaparsin)
Dose Escalation of ZIO-101 (Darinaparsin) given daily for five consecutive days to be repeated every 28 days for up to six months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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
3. Pediatric subjects will be eligible at the discretion of the primary investigator.
4. ECOG performance status score ≤ 2
5. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device \[IUD\], oral contraceptive or double barrier device), and must have a negative blood or urine pregnancy test within 1 week before beginning treatment. Sexually active men must also use acceptable contraceptive methods
6. Subjects must provide written informed consent prior to treatment
7. At least 4 weeks from prior completion of prior therapy to day 1 of study drug
8. Baseline toxicity assessment ≤ grade 1 except treatment induced alopecia (NCI Common Toxicity Criteria version 3.0)
9. Evidence of adequate multi-organ functional status as reflected by the following clinical laboratory values:
* Serum creatinine ≤ 2 times the upper normal limit OR a calculated creatinine clearance ≥ 50 cc/min
* Total bilirubin ≤ 2 times the upper normal limit
* Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal
10. Granulocytes in peripheral blood greater than or equal to 1 x 10(9) per liter, hemoglobin greater than or equal to 8.5 g/dL, and platelets greater than or equal to 50,000 /microL
Exclusion Criteria
2. Active heart disease as defined by an acute myocardial infarction within the previous 6 months before starting therapy, stable or unstable angina, clinically significant arrhythmia requiring medical management, OR New York Heart Association Classification of Functional Activities. Class 3: Subject has marked limitation in activities due to symptoms, even during less-than-ordinary activity and is comfortable only at rest OR Class 4: Severe limitations. Subject experiences symptoms even while at rest
3. Concomitant therapy for solid cancer
4. Pregnant subjects and those who are breast-feeding
5. History of an 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
6. Documented personal or family history of prolonged QT syndrome
7. 12 lead electrocardiogram with a corrected QT interval \> 460 milliseconds
8. History of confusion or dementia
9. History of seizure disorder
ALL
No
Sponsors
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Alaunos Therapeutics
INDUSTRY
Responsible Party
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Locations
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Houston, Texas, United States
Countries
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Other Identifiers
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SGL1002
Identifier Type: -
Identifier Source: org_study_id