WARNING
Only physicians experienced in cancer chemotherapy should use Cytarabine Injection.
For induction therapy patients should be treated in a facility with laboratory and supportive resources sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The main toxic effect of cytarabine is bone marrow suppression with leukopenia, thrombocytopenia and anemia. Less serious toxicity includes nausea, vomiting, diarrhea and abdominal pain, oral ulceration and hepatic dysfunction.
The physician must judge possible benefit to the patient against known toxic effects of this drug in considering the advisability of therapy with cytarabine. Before making this judgment or beginning treatment, the physician should be familiar with the following text.
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CYTARABINE SUMMARY
Cytarabine Injection
NOT FOR INTRATHECAL USE -
CONTAINS BENZYL ALCOHOL
FOR INTRAVENOUS OR SUBCUTANEOUS USE ONLY
Rx Only
Cytarabine Injection, an antineoplastic agent, is a sterile preserved solution for intravenous or subcutaneous administration, and is available in a 500 mg (20 mg/mL) multidose vial.
Cytarabine in combination with other approved anticancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and children. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia.
Intrathecal administration of cytarabine injection (preservative-free only) is indicated for the prophylaxis and treatment of meningeal leukemia.
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NEWS HIGHLIGHTS
Published Studies Related to Cytarabine
Combination of cladribine and cytarabine is effective for childhood acute myeloid leukemia: results of the St Jude AML97 trial. [2009.08]
Because cladribine can increase cytarabine triphosphate levels, we tested a cladribine-cytarabine combination in the St Jude AML97, trial in which this combination was administered before standard chemotherapy to 96 children with acute myeloid leukemia (AML) or myelodysplastic syndrome... Our results suggest that cladribine in combination with continuous-infusion cytarabine is effective therapy for childhood AML.
Patients with acute myeloid leukemia and RAS mutations benefit most from postremission high-dose cytarabine: a Cancer and Leukemia Group B study. [2008.10.01]
PURPOSE: RAS mutations occur in 12% to 27% of patients with acute myeloid leukemia (AML) and enhance sensitivity to cytarabine in vitro. We examined whether RAS mutations impact response to cytarabine in vivo... CONCLUSION: AML patients carrying mutRAS benefit from higher cytarabine doses more than wtRAS patients. This seems to be the first example of an activating oncogene mutation favorably modifying response to higher drug doses in AML.
A randomized study of clofarabine versus clofarabine plus low-dose cytarabine as front-line therapy for patients aged 60 years and older with acute myeloid leukemia and high-risk myelodysplastic syndrome. [2008.09.01]
We previously reported the feasibility of clofarabine and cytarabine combinations in AML. Questions remain as to (1) the therapeutic advantage of this combination and (2) the role of lower doses of clofarabine and cytarabine in older patients... This trial is registered at www.clinicaltrials.gov as no.
Adding lomustine to idarubicin and cytarabine for induction chemotherapy in older patients with acute myeloid leukemia: the BGMT 95 trial results. [2007.10]
BACKGROUND AND OBJECTIVES: Treatment of acute myeloid leukemia (AML) in older patients remains unsatisfactory. The BGMT 95 trial for older patients set out to improve the outcome of these patients by adding a third drug (lomustine) to a 5+7 idarubicin and cytarabine schedule at induction and evaluating intermediate-dose cytarabine as consolidation... CONCLUSIONS: Adding lomustine to induction with idarubicin and cytarabine therapy did not statistically improve survival in elderly patients with AML. Adding intermediate-dose cytarabine to consolidation therapy did not improve outcome.
Is cytarabine useful in the treatment of acute promyelocytic leukemia? Results of a randomized trial from the European Acute Promyelocytic Leukemia Group. [2006.12.20]
PURPOSE: Several phase II studies have suggested that cytarabine (AraC) was not required in the treatment of newly diagnosed acute promyelocytic leukemia (APL) patients receiving all-trans-retinoic acid (ATRA), an anthracycline, and maintenance therapy, and we aimed at confirming this finding in a randomized trial... CONCLUSION: These results support a role for AraC in addition to ATRA and anthracyclines in the treatment of newly diagnosed APL, at least using DNR at the cumulative dose we used and with the consolidation and maintenance regimens we used.
Clinical Trials Related to Cytarabine
2-Chlorodeoxyadenosine and Cytarabine in Patients With Idiopathic Hypereosinophilic Syndrome (HES) [Active, not recruiting]
Primary Objectives:
1. To determine the response rate, progression-free survival (PFS) and overall survival of
patients who receive 2-CdA + Ara-C.
2. To examine if there is any clonality in the cytokine expression of helper T cells or
cytokine receptor expression of eosinophils.
3. To determine the effect of 2-CdA on accumulation of Ara-C triphosphate in eosinophils.
Comparison of Anti HIV Drugs Used Alone or in Combination With Cytosine Arabinoside to Treat Progressive Multifocal Leukoencephalopathy (PML) in HIV-Infected Patients [Completed]
To compare the safety and efficacy of antiretroviral therapy (zidovudine plus either
didanosine or dideoxycytidine) versus antiretroviral therapy plus intravenous cytarabine
(Ara-C) versus antiretroviral therapy plus intrathecal Ara-C in the maintenance or
improvement of neurological function over 6 months in HIV-infected individuals who have
developed progressive multifocal leukoencephalopathy (PML). To compare the effect of these
three treatment regimens on Karnofsky score and MRI studies.
The effectiveness of Ara-C in the treatment of PML, caused by a human DNA papovavirus
(designated JC virus) infection, has not been determined, although the most encouraging
results have occurred with intrathecal administration of the drug.
PEG Interferon Alpha 2B and Low-Dose Ara-C in Early Chronic Phase CML [Active, not recruiting]
The goal of this clinical research study is to see if a new interferon which is given only
once a week with ARA-C works as well as standard interferon and low dose ARA-C. The safety
of this treatment will also be studied. In some patients, extra blood samples will be taken
to measure the effect of treatment on leukemia cells.
Lomustine and Intermediate Dose Cytarabine in Older Patients With AML [Completed]
A multicenter randomized trial was performed comparing induction therapy (IC: Idarubicin and
Cytarabine, 5+7) to ICL (the same drugs plus lomustine (CCNU), 200mg\m2 orally at day 1).
Patients in complete remission (CR) were then randomized to receive either maintenance
therapy or intensification with intermediate-dose cytarabine and idarubicin followed by
maintenance therapy.
DepoCyt Therapy in Patients With Neoplastic Meningitis From Lymphoma or a Solid Tumor [Completed]
The purpose of this study is to find out how well an experimental drug called DepoCyt works
for neoplastic meningitis (cancer that has spread to the tissues around the brain and spinal
cord). DepoCyt is a new slow-release form of the cancer drug called ara-C (cytarabine).
Cytarabine has been used for many years to treat cancer.
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