ELSPAR SUMMARY
ELSPAR * (Asparaginase) contains the enzyme L-asparagine amidohydrolase, type EC-2, derived from
Escherichia coli.
It is a white crystalline powder that is freely soluble in water and practically insoluble in methanol, acetone and chloroform. Its activity is expressed in terms of International Units (I.U.) according to the recommendation of the International Union of Biochemistry. The specific activity of ELSPAR is at least 225 I.U. per milligram of protein and each vial contains 10,000 I.U. of asparaginase and 80 mg of mannitol, an inactive ingredient, as a sterile, white lyophilized plug or powder for intravenous or intramuscular injection after reconstitution.
ELSPAR is indicated in the therapy of patients with acute lymphocytic leukemia. This agent is useful primarily in combination with other chemotherapeutic agents in the induction of remissions of the disease in pediatric patients. ELSPAR should not be used as the sole induction agent unless combination therapy is deemed inappropriate. ELSPAR is not recommended for maintenance therapy.
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NEWS HIGHLIGHTSMedia Articles Related to Elspar (Asparaginase)
Genentech And Biogen Idec Receive A Complete Response From The FDA For Rituxan For Chronic Lymphocytic Leukemia
Source: Health News from Medical News Today [2009.11.19]
Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec (Nasdaq: BIIB) announced today that the U.S.
Finding May Give Hope To More Leukemia Patients So They May Live Cancer-Free
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2009.11.16]
A new study from the Masonic Cancer Center, University of Minnesota shows that patients who have acute leukemia and are transplanted with two units of umbilical cord blood (UCB) have significantly reduced risk of the disease returning. This finding has the potential to change the current medical practice of using one unit of UCB for treatment of patients who are at high risk for recurrence of leukemia and other cancers of the blood and bone marrow. Michael Verneris, M.D.
Leukemia Drug May Help Some Ovarian Cancer Patients (HealthDay)
Source: Y! Health News Search RSS Feed [2009.11.12]
HealthDay - THURSDAY, Nov. 12 (HealthDay News) -- A drug for people with a form of
leukemia holds promise as a possible treatment for ovarian cancer, new
research suggests.
Leukemia Drug May Help Some Ovarian Cancer Patients
Source: MedicineNet Leukemia Specialty [2009.11.12]
Title: Leukemia Drug May Help Some Ovarian Cancer Patients
Category: Health News
Created: 11/12/2009 8:10:00 AM
Last Editorial Review: 11/12/2009
FDA Approved Leukemia Drug Shows Promising Activity In Ovarian Cancer Cells
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2009.11.11]
The drug Sprycel, approved for use by the U.S. Food and Drug Administration in patients with chronic myeloid leukemia, significantly inhibited the growth and invasiveness of ovarian cancer cells and also promoted their death, a study by researchers with UCLA's Jonsson Comprehensive Cancer Center found.
Published Studies Related to Elspar (Asparaginase)
Pharmacokinetics, pharmacodynamics, efficacy, and safety of a new recombinant asparaginase preparation in children with previously untreated acute lymphoblastic leukemia: a randomized phase 2 clinical trial. [2008.12.15]
The pharmacokinetics, pharmacodynamics, efficacy, and safety of a new recombinant Escherichia coli-asparaginase preparation was compared with Asparaginase medac. Thirty-two children with acute lymphoblastic leukemia were randomized to receive one of both agents at a dose of 5000 U/m(2) every 3 days, for a total of 8 doses during induction treatment...
Pharmacokinetics, pharmacodynamics, efficacy and safety of a new recombinant asparaginase preparation in children with previously untreated acute lymphoblastic leukemia- a randomized phase II clinical trial. [2008.09.19]
The pharmacokinetics, pharmacodynamics, efficacy and safety of a new recombinant E.coli-asparaginase preparation was compared to the commercially available asparaginase preparation Asparaginase medac(TM). 32 children with de novo ALL were randomized to receive one of both agents at a dose of 5,000 U/m(2) every 3 days for a total of 8 doses during induction treatment...
Changes in hypercoagulability by asparaginase: a randomized study between two asparaginases. [2006.03]
Alterations in hemostasis have frequently been observed in children with acute lymphoblastic leukemia. Thrombotic events are well documented in patients receiving L-asparaginase as a single agent or in combination with other chemotherapeutic drugs...
Long-term results of a randomized trial on extended use of high dose L-asparaginase for standard risk childhood acute lymphoblastic leukemia. [2005.10.01]
PURPOSE: Between September 1991 and May 1997, within the International Berlin-Frankfurt-Muenster Study Group (I-BFM-SG), a randomized study was performed aimed at assessing the efficacy of prolonged use of high-dose l-asparaginase (HD-l-ASP) during continuation therapy in children with standard risk (SR) acute lymphoblastic leukemia (ALL), treated with a reduced BFM-type chemotherapy... CONCLUSION: In this subset of patients, selected with criteria not including monitoring of minimal residual disease, application of extended HD-l-ASP may improve prognosis, compensating reduced leukemia control that results from adoption of a reduced-intensity BFM-backbone for treatment of children with SR ALL.
Pain intensity and bioavailability of intramuscular asparaginase and a local anesthetic: a double-blinded study. [2005.03]
CONCLUSIONS: Asparaginase with addition of lidocaine significantly decreases the pain as measured by the visual analog scale without changing the bioavailability or the absorption rate of the enzyme. (c) 2004 Wiley-Liss, Inc.
Clinical Trials Related to Elspar (Asparaginase)
Erwinase Study in Patients With Acute Lymphoblastic Leukemia [Recruiting]
Primary Objective:
- To enable US patients who are treated outside the duly recognized ALL protocols for acute
lymphoblastic leukemia and who are allergic to Escherichia Coli derived L-asparaginase,
whatever the formulation, to be treated with Erwinia chrysanthemic derived L-asparaginase
(Erwinase®), under IND 290.
Erwinia Asparaginase After Allergy to PEG-Asparaginase in Treating Young Patients With Acute Lymphoblastic Leukemia [Recruiting]
RATIONALE: Drugs used in chemotherapy, such as Erwinia asparaginase, work in different ways
to stop the growth of cancer cells, either by killing the cells or by stopping them from
dividing.
PURPOSE: This clinical trial is studying the side effects of Erwinia asparaginase and what
happens to the drug in the body in treating young patients with acute lymphoblastic leukemia
who are allergic to PEG-asparaginase.
ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia Intermittent Versus Continuous PEG Asparaginase [Recruiting]
The purpose of this study is to investigate if intramuscular PEG-asparaginase administered
either at six or two week intervals from day 92 until 8 months from diagnosis for patients
with non-HR ALL will result in equal probability of Event Free Survival
Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (IND 104224) [Recruiting]
This is a phase I study using the Erwinia form of asparaginase in place of the E. coli form
using a standard re-induction regimen (Vincristine, Dexamethasone, Doxorubicin) for patients
with relapsed ALL who have developed an allergy to the E. coli formulation. This study will
administer the drug intravenously instead of the usual intramuscular route. The dose of
Erwinia will be escalated in the absence of dose limiting toxicity. Patients must have first
or second relapse ALL with a history of prior systemic reaction to E. coli asparaginase.
Erwinase Master Treatment Protocol [Available]
The purpose of this study is to make Erwinase available to patients with acute lymphoblastic
leukemia (ALL) who have had previous allergic reactions to certain formulations of
L-asparaginase.
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