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Oncaspar (Pegaspargase) - Summary

 
 



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 HIGHLIGHTS

Media Articles Related to Oncaspar (Pegaspargase)

Latest results of investigational cellular therapy in pediatric acute lymphoblastic leukemia, and first results of lymphoma trial
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2014.12.10]
The latest results of clinical trials of more than 125 patients testing an investigational personalized cellular therapy known as CTL019 was presented by a University of Pennsylvania research team at...

Young adults with acute lymphoblastic leukemia benefit from therapies developed for children
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2014.12.10]
Results from a large, prospective clinical trial add to mounting evidence that adolescent and young adult patients--aged 16 to 39 with acute lymphoblastic leukemia (ALL)--tend to fare better when...

Pilot study engineers pediatric patients' own immune cells to hunt down cancer cells in blood
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2014.12.10]
An innovative cell therapy against a highly aggressive form of acute lymphoblastic leukemia (ALL) continues to show highly promising results in children treated in a pilot study.

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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.

Insulin infusion to treat severe hypertriglyceridemia associated with pegaspargase therapy: a case report. [2011.03]
We describe a pediatric patient with acute leukemia who developed an uncommon but significant metabolic consequence of pegaspargase therapy-severe hypertriglyceridemia (hyperTG). We also relate our experience with continuous insulin infusion treatment for pegaspargase-induced hyperTG... Our review of the literature suggests that apolipoprotein E polymorphism may influence the development of hyperlipidemia in acute lymphoblastic leukemia patients receiving asparaginase therapy and may identify patients at high risk for developing asparaginase-induced hyperTG.

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.

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Clinical Trials Related to Oncaspar (Pegaspargase)

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.

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®.

Trial of Oncaspar� and Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia [Recruiting]
This is an assessment of efficacy and safety of three different doses of pegylated recombinant asparaginase (PEG-rASNase) in comparison to Oncaspar® during treatment of adults with de novo acute lymphoblastic leukaemia (ALL). This study will provide first data for determining specific asparaginase doses to yield various durations of L-asparagine (ASN) depletion which are required within different treatment phases of ALL therapy.

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.

Temsirolimus, Dexamethasone, Mitoxantrone Hydrochloride, Vincristine Sulfate, and Pegaspargase in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma [Not yet recruiting]
This phase I trial studies the side effects and the best dose of temsirolimus when given together with dexamethasone, mitoxantrone hydrochloride, vincristine sulfate, and pegaspargase in treating young patients with relapsed acute lymphoblastic leukemia or non-Hodgkin lymphoma. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, mitoxantrone hydrochloride, vincristine sulfate, and pegaspargase work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving temsirolimus together with combination chemotherapy may kill more cancer cells

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Reports of Suspected Oncaspar (Pegaspargase) Side Effects

Hypersensitivity (12)Hypertriglyceridaemia (10)Dyspnoea (8)Pruritus (7)Hypotension (7)Pancreatitis (7)Urticaria (6)Pyrexia (6)Infusion Related Reaction (6)Death (5)more >>


Page last updated: 2014-12-10

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