ONCASPAR SUMMARY
ONCASPAR®, the ENZON trademark for pegaspargase, is a modified version of the enzyme L-asparaginase. It is an oncolytic agent used in combination chemotherapy for the treatment of patients with acute lymphoblastic leukemia who are hypersensitive to native forms of L-asparaginase (as described in CLINICAL PHARMACOLOGY).
ONCASPAR® is indicated for patients with acute lymphoblastic leukemia who require L-asparaginase in their treatment regimen, but have developed hypersensitivity to the native forms of L-asparaginase (CLINICAL PHARMACOLOGY). ONCASPAR®, like native L-asparginase, is generally used in combination with other chemotherapeutic agents, such as vincristine, methotrexate, cytarabine, daunorubicin, and doxorubicin.1,5 Use of ONCASPAR® as a single agent should only be undertaken when multi-agent chemotherapy is judged to be inappropriate for the patient.
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NEWS HIGHLIGHTSMedia Articles Related to Oncaspar (Pegaspargase)
Childhood Acute Lymphoblastic Leukemia
Source: MedicineNet Leukemia Specialty [2009.10.28]
Title: Childhood Acute Lymphoblastic Leukemia
Category: Diseases and Conditions
Created: 10/28/2009 5:07:00 PM
Last Editorial Review: 10/28/2009 5:07:19 PM
Published Studies Related to Oncaspar (Pegaspargase)
A pharmacoeconomic analysis of pegaspargase versus native Escherichia coli L-asparaginase for the treatment of children with standard-risk, acute lymphoblastic leukemia: the Children's Cancer Group study (CCG-1962). [2002.03]
PURPOSE: The purpose of this pharmacoeconomic analysis was to compare pegaspargase. a newer chemotherapeutic agent used for treating acute lymphoblastic leukemia, with native Escherichia coli L-asparaginase in induction, delayed intensification 1 and delayed intensification 2... CONCLUSION: We recommend that pegaspargase not be withheld from treatment protocols solely because of its higher pharmacy costs.
FDA drug approval summary: pegaspargase (oncaspar) for the first-line treatment of children with acute lymphoblastic leukemia (ALL). [2007.08]
On July 24, 2006, the U.S. Food and Drug Administration granted approval to pegaspargase (Oncaspar; Enzon Pharmaceuticals, Inc., Bridgewater, NJ; hereafter, O) for the first-line treatment of patients with acute lymphoblastic leukemia (ALL) as a component of a multiagent chemotherapy regimen...
Pharmacodynamics and safety of intravenous pegaspargase during remission induction in adults aged 55 years or younger with newly diagnosed acute lymphoblastic leukemia. [2007.04.01]
In contrast to that in children, pharmacokinetic, pharmacodynamic, and safety information on pegaspargase in adults is very limited. We administered a single intravenous dose of pegaspargase (2000 IU/m2) as part of a standard frontline induction regimen to 25 adults with newly diagnosed acute lymphoblastic leukemia (ALL), and obtained serum samples on several time points...
Pegaspargase: a review of clinical studies. [2003.09.26]
The chemotherapy agent L-asparaginase has been an important part of acute lymphoblastic leukemia therapy for over 30 years. Two of the main disadvantages of the drug are (1) the need for frequent intramuscular injection and (2) a very high rate of allergic reactions... In the review below, we outline the history of therapy with L-asparaginase, the development of PEG-L-asparaginase, and clinical trials in which it has been administered.
PEG-asparaginase (Oncaspar) 2500 U/m(2) BSA in reinduction and relapse treatment in the ALL/NHL-BFM protocols. [2002.02]
PURPOSE: As previous data had shown that only two-thirds of patients had the predicted activity time courses when PEG-asparaginase 1000 U/m(2) was used in reinduction after native E. coli asparaginase in induction treatment of acute lymphoblastic leukaemia (ALL), drug monitoring was performed with the use of a higher dose... CONCLUSIONS: Comparison of these data with activities after 1000 U/m(2) PEG-asparaginase showed no prolongation of the time with activity in the therapeutic range with the higher dose. Therefore, for a longer duration of therapeutic activity, administration of further doses is mandatory.
Clinical Trials Related to Oncaspar (Pegaspargase)
A Study Evaluating IV Oncaspar® and IV Gemzar® in the Treatment of Solid Tumors and Lymphoma [Terminated]
This study will research the side effects of pegaspargase (pronounced "peg-as-par-gase"); its
brand name is ONCASPAR® when it is used with another FDA-approved cancer treatment
(chemotherapy) drug called gemcitabine HCl (pronounced "gem-site-a-bean"; its brand name is
GEMZAR®.
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
Oncaspar/Doxil/Decadron in Patients With Refractory Lymphoid Malignancies [Recruiting]
This is an exploratory study to study the efficacy of combination regimen of
Oncaspar/Doxil/Decadron (ODD) in patients with refractory lymphoid malignancies. Patients
with any form of lymphoid malignancy will be eligible: acute lymphoblastic leukemia, chronic
lymphocytic leukemia, non-Hodgkin's lymphoma, Hodgkin's lymphoma, multiple myeloma and
plasma cell leukemia. Patients must have failed standard regimens for their cancers and
could have had unlimited number of prior regimens. Patients will be staged appropriately
for their disease with clinical examination, laboratory tests, and imaging studies. Both
Oncaspar and Doxil will be given on day 1 and 15. Patients will be clinically evaluated
prior to each cycle and will have disease assessments every 2 cycles. Responding patients
will continue therapy until disease progression or excessive toxicity. Responders who are
candidates for allogenic stem cell transplantation could go to conditioning chemotherapy and
stem cell transplant after 4 cycles of ODD.
EZN-2285 or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia [Recruiting]
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer
cells, either by killing the cells or by stopping them from dividing. Giving more than one
drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This randomized clinical trial is studying giving EZN-2285 together with
combination chemotherapy to see how well it works compared with giving pegaspargase together
with combination chemotherapy in treating younger patients with newly diagnosed high-risk
acute lymphoblastic leukemia.
Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia [Recruiting]
RATIONALE: Pegaspargase may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth
of cancer cells, either by killing the cells or by stopping them from dividing. Giving more
than one drug (combination chemotherapy) together with pegaspargase may kill more cancer
cells.
PURPOSE: This clinical trial is studying the side effects of giving pegaspargase together
with combination chemotherapy and to see how well it works in treating patients with newly
diagnosed high-risk acute lymphoblastic leukemia.
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