Intensified Post Remission Therapy Containing PEG-Asparaginase - Full Text View

Sponsored by:	Norris Comprehensive Cancer Center
Information provided by:	Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00184041

Purpose

This study is for patients with recently diagnosed blood cancer, called acute lymphoblastic leukemia (ALL). The standard treatment for this disease consists of many chemotherapy drugs that are given in different combinations in several steps. Each step of treatment is called a cycle. Patients will be treated with the chemotherapy drugs that are routinely used in ALL and which are given in multiple treatment cycles over several months. All the chemotherapy drugs that are used in this study have been approved by the Food and Drug Administration (FDA).

One of the drugs, which is typically given to patients with ALL, is called Asparaginase. It is given together with the other drugs throughout the different cycles of treatment. This drug can be derived from several sources. The standard source is called E. coli Asparaginase, which is associated with a risk of allergic reactions. This drug stays in the body for a very short period of time; therefore, it has to be injected daily for 9-14 days in a cycle of treatment.

In this study, a different form of Asparaginase will be used, called PEG-Asparaginase (also called Oncospar), which remains in the body for about two weeks, therefore, it can be given only once in a cycle of treatment and still maintains high blood levels of the drug. PEG-Asparaginase has recently been approved by the FDA to treat ALL. Most of the experience with the drug has been in children with ALL. In children it was found to be as safe as the standard form of Asparaginase and with less allergic reaction. It was also found to have the same effectiveness on ALL. The experience with this drug in adults has been more limited.

The purpose of the study is to find out what side effects occur in adults when PEG-Asparaginase is given with other chemotherapy drugs and to see what effect it has on the response to treatment of ALL. Another purpose is to find out if the allergic reactions are reduced with PEG-Asparaginase. In children there is some early information that PEG-Asparaginase produces fewer antibodies than E.coli Asparaginase. Therefore, another purpose of the study is to see how many adult patients who receive PEG-Asparaginase develop antibodies against the drug.

Condition	Intervention	Phase
Acute Lymphoblastic Leukemia	Drug: Daunorubicin, Vincristine, Prednisone, Methotrexate, PEG-Asparaginase, 6-Mercaptopurine, Cytoxan, Cytosine Arabinoside, VM-26 and 6-Thioguanine	Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Cyclophosphamide Cytarabine Cytarabine hydrochloride Mercaptopurine 6-Mercaptopurine L-Asparaginase Daunorubicin hydrochloride Daunorubicin Methotrexate Prednisone Vincristine sulfate Vincristine Thioguanine Pegaspargase Teniposide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Treatment Of Newly Diagnosed Adult Acute Lymphoblastic Leukemia With Intensified Post Remission Therapy Containing PEG-Asparaginase.

Further study details as provided by Norris Comprehensive Cancer Center:

Primary Outcome Measures:

Assessment of pt developing anti-asparaginase antibody [ Time Frame: assessed 3 times ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Response [ Time Frame: By Bone Marrow assessment ] [ Designated as safety issue: No ]

Estimated Enrollment:	31
Study Start Date:	July 2004
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Induction I/II, consolidation I/II/III/IV and Maintenance

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with previously untreated ALL subtypes L1 and L2.
Patients with de novo Philadelphia (Ph)+ ALL (i.e. excluding those that are after blastic of CML) are eligible. However they will be referred to allogeneic hematopoietic stem cell transplantation and will continue on the study until they are ready to undergo the transplantation. At that time they will discontinue the study. Patients who are unable to undergo allogeneic transplantation will continue on the study.
Presence of 25% or more of lymphoblasts in the bone marrow by FAB criteria, confirmed by TdT positivity or by flow cytometry with standard ALL markers.
Patients may have received prior steroids.
Age: 18 - 55 years
Signed Informed Consent

Exclusion Criteria:

Patients with Burkitt's ALL (L3 subtype) or CML lymphoblastic crisis are not eligible (including CML patients who present with ALL blastic crisis).
Psychological or emotional disorders which will make a valid informed consent impossible.
Bilirubin >1.5 mg/dl, creatinine > 2.5 mg/dl
Symptomatic congestive heart failure or unstable angina
Pregnant or lactating females
Known HIV positive status

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184041

Contacts

Contact: Dan Douer, MD	(323)865-3911	douer_d@ccnt.hsc.usc.edu
Contact: Kristy Watkins, R.N.	(323)865-0452	watkins_k@ccnt.hsc.usc.edu

Locations

United States, California
USC/Norris Comprehensive Cancer Center and Hospital	Recruiting
Los Angeles, California, United States, 90032
Contact: Kristy Watkins, R.N. 323-865-0452 watkins_k@ccnt.hsc.usc.edu
Contact: Dan Douer, MD (323)865-3911 douer_d@ccnt.hsc.usc.edu

Sponsors and Collaborators

Norris Comprehensive Cancer Center

Investigators

Principal Investigator:

Dan Douer, MD

University of Southern California

More Information

Responsible Party:	University of Southern California ( Dan Douer, MD )
Study ID Numbers:	9L-03-1
Study First Received:	September 12, 2005
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00184041
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Asparaginase
Prednisone
Daunorubicin
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Thioguanine
Vincristine
Cyclophosphamide
6-Mercaptopurine

Acute lymphoblastic leukemia, adult
Folic Acid
Teniposide
Pegaspargase
Leukemia
Lymphatic Diseases
Methotrexate
Lymphoproliferative Disorders
Lymphoma
Cytarabine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents
Folic Acid Antagonists

Abortifacient Agents, Nonsteroidal
Antibiotics, Antineoplastic
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009