WARNING
DepoCyt® (cytarabine liposome injection) should be administered only under the supervision of a qualified physician experienced in the use of intrathecal cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. In all clinical studies, chemical arachnoiditis, a syndrome manifested primarily by nausea, vomiting, headache and fever, was a common adverse event. If left untreated, chemical arachnoiditis may be fatal. The incidence and severity of chemical arachnoiditis can be reduced by coadministration of dexamethasone (see WARNINGS). Patients receiving DepoCyt should be treated concurrently with dexamethasone to mitigate the symptoms of chemical arachnoiditis (see DOSAGE AND ADMINISTRATION).
|
DEPOCYT SUMMARY
RX ONLY
DEPOCYT®
(cytarabine liposome injection)
For Intrathecal Use Only
50 mg vial
DepoCyt® (cytarabine liposome injection) is a sterile, injectable suspension of the antimetabolite cytarabine, encapsulated into multivesicular lipid-based particles.
DepoCyt® (cytarabine liposome injection) is indicated for the intrathecal treatment of lymphomatous meningitis. This indication is based on demonstration of increased complete response rate compared to unencapsulated cytarabine. There are no controlled trials that demonstrate a clinical benefit resulting from this treatment, such as improvement in disease-related symptoms, or increased time to disease progression, or increases survival.
|
NEWS HIGHLIGHTSMedia Articles Related to Depocyt (Cytarabine)
Antibiotic-Resistant Meningitis Reported in U.S.
Source: MedicineNet ciprofloxacin Specialty [2009.02.26]
Title: Antibiotic-Resistant Meningitis Reported in U.S.
Category: Health News
Created: 2/26/2009 2:00:00 AM
Last Editorial Review: 2/26/2009
Encephalitis and Meningitis
Source: MedicineNet Pneumococcal Vaccination Specialty [2007.11.21]
Title: Encephalitis and Meningitis
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 11/21/2007
Early warning signs for meningitis in children identified
Source: The Doctors Lounge - Infections
A number of early symptoms for meningococcal disease in children could substantially speed up diagnosis.
Published Studies Related to Depocyt (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 Depocyt (Cytarabine)
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.
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.
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.
Treatment of Acute Lymphoblastic Leukemia or Aggressive Lymphoma With Relapse in Central Nervous System With Depocyt [Active, not recruiting]
Patients with acute lymphoblastic leukaemia or very aggressive lymphoma and documented
isolated CNS relapse or CNS relapse combined with other relapse sites should receive therapy
with intrathecal DepoCyte at least once. Treatment may be repeated during induction phase
each 2 weeks and monthly during maintenance phase. The study aim is to replace the usual 2-3
weekly applications of intrathecal triple therapy with one application of DepoCyte. Primary
objective is the response rate after one application of DepoCyte. Further objectives are the
compilation of data regarding safety and toxicity
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.
|
