Track topics on Twitter Track topics that are important to you
The goal of this clinical research study is to find the highest tolerable dose of 4'-thio-araC (thiarabine) that can be given to patients with advanced blood cancer. The safety of this drug will also be studied and 2 different dose schedules will be tested.
The Study Drug Thiarabine is designed to damage and destroy the DNA of cancer cells. This may cause the cells to die.
If you are found to be eligible to take part in this study, you will be assigned to 1 of 2 study groups based on when you joined the study. The first set of 3 participants will be enrolled in Group 1, and the 2nd set of 3 participants will be enrolled in Group 2. The 3rd set of 3 participants will be enrolled in Group 1, then the 4th set of 3 participants in Group 2, and so on until all participants are enrolled.
- Group 1 will receive thiarabine for 3 days in a row in each cycle.
- Group 2 will receive thiarabine for 5 days a row in each cycle.
Cycles in this study are 3-6 weeks long, depending on how you are doing. You may begin a new cycle when your blood cell counts have returned to an appropriate level. However, you may begin a new study cycle earlier than that if the disease gets worse or does not improve.
The dose of thiarabine you receive will depend on when you joined this study. The first set of participants will receive the lowest dose level of thiarabine. Each new set will receive a higher dose of thiarabine than the set before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of thiarabine is found.
Study Drug Administration:
You will receive thiarabine by vein over about 1 hour (+/- 15 minutes) on Days 1-3 (Group 1) or Days 1-5 (Group 2) of each cycle.
Blood (about 2 tablespoons) will be drawn for routine tests 1 or 2 times a week. If the disease responds well, the study doctor may decide these blood tests will occur less often.
At every study visit, you will be asked about any drugs you may be taking and symptoms you may be having.
You will have an ECG within 2 days before each cycle.
At any time the doctor thinks it is needed, you will have a bone marrow aspiration to check the status of the disease.
Length of Participation:
You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will be taken off study early if intolerable side effects occur. You may be taken off study early if the disease gets worse.
At 30 days after your last study drug dose, you will be asked about any side effects you may be having. This may be done during a regular clinic visit or by phone call from the study doctor or staff.
This is an investigational study. Thiarabine is not FDA approved or commercially available. It is currently being used for research purposes only.
Up to 70 patients will take part in this study. All will be enrolled at M. D. Anderson.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
3 Day Thiarabine, 5 Day Thiarabine
UT MD Anderson Cancer Center
Not yet recruiting
M.D. Anderson Cancer Center
Published on BioPortfolio: 2014-08-27T03:13:07-0400
The purpose of this research study is to collect, freeze and store leukemia cells from the blood or bone marrow of patients that have advanced chronic lymphocytic leukemia (CLL) that is no...
RATIONALE: Determination of genetic markers for acute lymphoblastic leukemia and acute promyelocytic leukemia may help identify patients with this disease and help predict the outcome of t...
The purpose of this study is to evaluate clinical and laboratory safety associated with the administration of GVAX leukemia vaccine and to determine the feasibility of generation of GVAX l...
RATIONALE: Drugs used in chemotherapy, such as flavopiridol, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. PURP...
Acute myeloid leukemia (AML) is a group of genetically highly heterogeneous malignant disease . The disease is the most common type of adult acute leukemia. Overall survival (OS) was less ...
Galectins are carbohydrate-binding proteins and these have very high affinity for β-galactoside containing glycoproteins and glycolipids. Amongst sixteen types of galectin, the role of galectin 1, 3,...
Myeloid leukemia cutis is the terminology used for cutaneous manifestations of myeloid leukemia.
Exposures to DNA-damaging drugs and ionizing radiations increase risks of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
A replication-defective strain of Murine leukemia virus (LEUKEMIA VIRUS, MURINE) capable of transforming lymphoid cells and producing a rapidly progressing lymphoid leukemia after superinfection with FRIEND MURINE LEUKEMIA VIRUS; MOLONEY MURINE LEUKEMIA VIRUS; or RAUSCHER VIRUS.
A strain of Murine leukemia virus (LEUKEMIA VIRUS, MURINE) producing leukemia of the reticulum-cell type with massive infiltration of liver, spleen, and bone marrow. It infects DBA/2 and Swiss mice.
A strain of Murine leukemia virus (LEUKEMIA VIRUS, MURINE) arising during the propagation of S37 mouse sarcoma, and causing lymphoid leukemia in mice. It also infects rats and newborn hamsters. It is apparently transmitted to embryos in utero and to newborns through mother's milk.
A chronic leukemia characterized by a large number of circulating prolymphocytes. It can arise spontaneously or as a consequence of transformation of CHRONIC LYMPHOCYTIC LEUKEMIA.
A lymphoid leukemia characterized by a profound LYMPHOCYTOSIS with or without LYMPHADENOPATHY, hepatosplenomegaly, frequently rapid progression, and short survival. It was formerly called T-cell chronic lymphocytic leukemia.
Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...