- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00421213
Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow Cancers
July 18, 2012 updated by: Alaunos Therapeutics
The study of safety of a new organic arsenic compound in the treatment of hematological malignancies.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Miami, Florida, United States
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Illinois
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Chicago, Illinois, United States
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Maryland
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Bethesda, Maryland, United States
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North Dakota
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Fargo, North Dakota, United States
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South Dakota
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Sioux Falls, South Dakota, United States
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West Virginia
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Morgantown, West Virginia, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
- Hodgkin's or non-Hodgkin's Lymphoma.
- ≥ 1 prior therapy and currently requiring therapy.
- Evaluable disease (defined by disease-specific criteria listed in Appendix 1)
- ≥ 18 years of age.
- ECOG performance score ≤ 2 (see Appendix 2).
- Life-expectancy ≥ 2 months.
- Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee with jurisdiction over the site.
- No anti-cancer therapy exception of hydroxyurea ≤ 3 weeks before Baseline (Day 1, Cycle 1).
The following clinical laboratory values < 2 weeks before Baseline:
- Creatinine ≤ 2X upper limit of normal (ULN).
- Total bilirubin ≤ 2X ULN.
- Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3X ULN.
Exclusion Criteria
- New York Heart Association (NYHA) functional class ≥3 myocardial infarction (see Appendix ) within 6 months before Baseline or 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).
- Pregnant and/or lactating female. (Women of childbearing age must use effective contraception from Screening through the duration of study participation).
- Uncontrolled infection.
- Prior seizures ≥ grade-3 in CTC v.3 criteria.
- Arsenic allergy.
- Significant neuropathology, defined as grade > 2 per CTCAE Version 3.0.
- Confusion or dementia.
- Prior history of neurological deficits (e.g., stroke, dementia, ischemia) that has the potential to confound a post-dose neurological assessment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Single Arm
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300mg/m2 of Darinaparsin given daily for five consecutive days to be repeated every 28 days for up to six months.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response Rate
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
toxicities
Time Frame: 6 months
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
January 10, 2007
First Submitted That Met QC Criteria
January 10, 2007
First Posted (Estimate)
January 11, 2007
Study Record Updates
Last Update Posted (Estimate)
July 19, 2012
Last Update Submitted That Met QC Criteria
July 18, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SGL2003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hematologic Neoplasms
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St. Jude Children's Research HospitalRecruitingRefractory Hematologic Malignancy | Relapsed Hematologic MalignancyUnited States
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Not yet recruitingHematologic MalignancyChina
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Innovent Biologics (Suzhou) Co. Ltd.Recruiting
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Massachusetts General HospitalRecruiting
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Fondazione EMN Italy OnlusCompletedHEMATOLOGIC MALIGNANCIESItaly
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Center for International Blood and Marrow Transplant...National Cancer Institute (NCI); National Heart, Lung, and Blood Institute... and other collaboratorsCompletedHematologic MalignancyUnited States
-
Rigshospitalet, DenmarkNovo Nordisk A/SCompletedHematologic MalignancyDenmark
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SecuraBioCompletedHematologic MalignancyUnited States, Italy
-
Duke UniversityActive, not recruitingHematologic MalignancyUnited States
-
St. Petersburg State Pavlov Medical UniversityCompleted
Clinical Trials on Darinaparsin
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Alaunos TherapeuticsUnknownHEPATOCELLULAR CARCINOMAUnited States
-
Solasia Pharma K.K.CompletedPeripheral T-Cell LymphomaHong Kong, Japan, Taiwan, Korea, Republic of
-
Alaunos TherapeuticsCompleted
-
Solasia Pharma K.K.CompletedPeripheral T-cell LymphomaJapan
-
Solasia Pharma K.K.Synex Consulting Korea Ltd.CompletedPeripheral T-cell LymphomaKorea, Republic of
-
Alaunos TherapeuticsCompleted
-
Alaunos TherapeuticsCompletedLymphoma | Multiple Myeloma | Acute Leukemia | Chronic Myeloproliferative Disease | Chronic Lymphoproliferative Disease | Poor-risk Myelodysplasia (MDS)United States
-
Alaunos TherapeuticsUnknownAdvanced CancerUnited States
-
Alaunos TherapeuticsUnknownAdvanced Solid Tumors | LymphomasCanada
-
Alaunos TherapeuticsCompletedAdvanced Solid TumorsUnited States