A Phase 1 interventional study of ZIO-101 (Darinaparsin) in Acute Leukemia, Chronic Myeloproliferative Disease and Chronic Lymphoproliferative Disease, sponsored by Alaunos Therapeutics. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-19.
Sponsored by Alaunos Therapeutics · Phase 1, Interventional, and Treatment
This study uses a new investigational (not yet approved by the FDA for widespread use) drug called ZIO-101, an organic arsenical. You must be diagnosed to have relapsed/refractory leukemia or lymphoma (blood cancer) and have tried other standard therapies.
This study is designed to determine whether ZIO-101 may be given safely. The study will also test whether ZIO-101 helps to treat blood cancer.
We anticipate that approximately 22 to 35 patients will take part in this study.
Arsenic has been used as a medicinal agent for centuries in many different cultures. Most recently in the United States, an inorganic arsenic compound was approved by the FDA for the treatment of patients with relapsed acute promyelocytic leukemia (APL). However, use of inorganic arsenic is limited by a narrow range of activity and systemic toxicity, most notably of the cardiac system.
ZIO-101 is an organic arsenic derivative. In vitro testing in both the National Cancer Institute (NCI) cancer cell panel and in vivo testing in a leukemia animal model demonstrated substantial activity of SGLU against hematologic cancers. In vitro testing of SGLU using the NCI human cancer cell panel also detected activity against lung, colon and brain cancers, melanoma, and ovary and kidney cancers. Moderate activity was seen against breast and prostate cancers cells. Data suggest that organic arsenic generates reactive oxygen species in the cells to induce apoptosis and cell cycle arrest.
The purpose of this study is to find answers to the following questions:
A series of tests will be taken throughout the study: medical history will be recorded, a physical exam performed, an electrocardiogram (EKG) (a measurement of your heart activity), blood tests. The amount of blood taken for these lab tests will equal about 2 1/2 tablespoons. In addition, a urine pregnancy test (if applicable), and a urine sample taken to test if your kidneys are working correctly. To see the current condition of your blood cancer, additional tests may need to be performed if they have not already been done recently. These tests may include: a bone marrow biopsy, special testing of your blood, a CT scan and a bone scan.
Immediately before being treated with ZIO-101, you will have another physical examination, you will also be asked about any medicines you are taking and how you are feeling. The blood tests may need to be repeated along with the EKG and the urine test. In addition, a small blood sample must be taken immediately before the injection of ZIO-101.
The injections of ZIO-101 will take approximately one hour. Following the first injection only, you will have 6 samples of blood taken at 0.5, 1, 2, 4, 8 and 12 hours. Additional blood samples will be taken prior to each dose of ZIO-101 only. You will also have repeat EKG within one hour after completing the injection. This process will be repeated for 5 consecutive days.
Your next visit will be Week 2 and at the onset of this visit, a blood sample will be taken and you will be asked how you feel. At Weeks 3 and 4, another blood sample will be taken and you will be asked how you feel.
At the end of Week 4, a new cycle begins. Immediately before being treated with ZIO-101, you will have a physical examination, you will be asked about any medicines you are taking and how you are feeling. The blood tests will be repeated along with the EKG and the urine test. In addition, any test used to measure your blood cancer will be repeated toward the end of the cycle.
You may receive up to six of these cycles.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 12 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Alaunos Therapeutics is the lead sponsor of 37 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects must have the following clinical laboratory values:
Exclusion Criteria:
Subjects with any one of the following criteria will not be eligible for study participation:
Drug: ZIO-101 (Darinaparsin)
ZIO-101 (Darinaparsin) given for five consecutive days to be repeated every 28 days for up to six months. This is a dose escalation study.
Also known as: ZIO-101
Response Rate
Time frame: 6 months
The RECIST criteria will be used for patients with all leukemias and myelodysplastic syndromes.
Time frame: 6 months
Patients with lymphoma or myeloma will be assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas.
Time frame: 6 months
EBMT, IBMTR and ABMTR criteria for definition of response, relapse and progression in patients with multiple myeloma .
Time frame: 6 months
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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