EZN-2285 or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia - Full Text View

Purpose

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.

Condition	Intervention
Leukemia	Drug: SC-PEG E. coli L-asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: methotrexate Drug: pegaspargase Drug: prednisone Drug: vincristine sulfate Procedure: radiation therapy

MedlinePlus related topics:

Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

ChemIDplus related topics:

Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Cytarabine Cytarabine hydrochloride L-Asparaginase Daunorubicin hydrochloride Daunorubicin Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Methotrexate Prednisone Vincristine sulfate Vincristine Pegaspargase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label

Official Title:	A Pilot Study of Intravenous EZN-2285 (SC-PEG E. Coli L-Asparaginase, IND# 100594) or Intravenous Oncaspar® in the Treatment of Patients With High-Risk Acute Lymphoblastic Leukemia

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Pharmacokinetics of SC-PEG E. coli L-asparaginase (EZN-2285) compared to pegaspargase during induction and consolidation therapy [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacodynamics of EZN-2285 compared to pegaspargase during induction and consolidation therapy [ Designated as safety issue: No ]
Response rate [ Designated as safety issue: No ]
Event-free survival [ Designated as safety issue: No ]
Minimal residual disease at day 29 of induction therapy [ Designated as safety issue: No ]
Complete remission rates [ Designated as safety issue: No ]
Immunogenicity of EZN-2285 compared to pegaspargase [ Designated as safety issue: No ]
Toxicities [ Designated as safety issue: Yes ]

Estimated Enrollment:	123
Study Start Date:	July 2008
Estimated Primary Completion Date:	March 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental Patients receive SC-PEG E. coli L-asparaginase (EZN-2285) together with combination chemotherapy. Patients receive chemotherapy by mouth, infusion, injection, and intrathecally. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 4 years.	Drug: SC-PEG E. coli L-asparaginase Given IV Drug: cyclophosphamide All drugs are given IV Drug: cytarabine Given IV, intrathecally, and subcutaneously Drug: daunorubicin hydrochloride All drugs are given IV Drug: dexamethasone Both are given IV or orally Drug: doxorubicin hydrochloride All drugs are given IV Drug: methotrexate Given IV, intrathecally, and orally Drug: prednisone Both are given IV or orally Drug: vincristine sulfate All drugs are given IV Procedure: radiation therapy Some patients undergo cranial radiotherapy
Arm II: Active Comparator Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy by mouth, infusion, injection, and intrathecally. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 4 years.	Drug: cyclophosphamide All drugs are given IV Drug: cytarabine Given IV, intrathecally, and subcutaneously Drug: daunorubicin hydrochloride All drugs are given IV Drug: dexamethasone Both are given IV or orally Drug: doxorubicin hydrochloride All drugs are given IV Drug: methotrexate Given IV, intrathecally, and orally Drug: pegaspargase Given IV Drug: prednisone Both are given IV or orally Drug: vincristine sulfate All drugs are given IV Procedure: radiation therapy Some patients undergo cranial radiotherapy

Show Detailed Description

Eligibility

Ages Eligible for Study:	1 Year to 30 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Newly diagnosed high-risk B-precursor acute lymphoblastic leukemia
No Down syndrome
No testicular leukemia
Enrolled on COG-AALL03B1 study or the successor classification study

PATIENT CHARACTERISTICS:

WBC ≥ 50,000/μL for patients age 1-9 OR any WBC count for patients age 10-30 or for patients treated with prior steroids
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

No prior cytotoxic chemotherapy except for steroid therapy or intrathecal cytarabine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671034

Locations


United States, California
	Children's Hospital of Orange County	Recruiting
	Orange, California, United States, 92868
	Contact: Violet Shen 714-532-8636
	Stanford Cancer Center	Recruiting
	Stanford, California, United States, 94305-5824
	Contact: Clinical Trials Office - Stanford Cancer Center 650-498-7061 cctoffice@stanford.edu

United States, Colorado
	Children's Hospital Center for Cancer and Blood Disorders	Recruiting
	Aurora, Colorado, United States, 80045
	Contact: Kelly Maloney 720-777-6673

United States, Connecticut
	Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center	Recruiting
	Farmington, Connecticut, United States, 06360-2875
	Contact: Clinical Trials Office - Carole and Ray Neag Comprehensive Can 800-579-7822

United States, District of Columbia
	Children's National Medical Center	Recruiting
	Washington, District of Columbia, United States, 20010-2970
	Contact: Clinical Trials Office - Children's National Medical Center 202-884-2549

United States, Indiana
	Indiana University Melvin and Bren Simon Cancer Center	Recruiting
	Indianapolis, Indiana, United States, 46202-5289
	Contact: Clinical Trials Office - Indiana University Cancer Center 317-274-2552

United States, Maryland
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Recruiting
	Baltimore, Maryland, United States, 21231-2410
	Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu

United States, Missouri
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Recruiting
	St. Louis, Missouri, United States, 63110
	Contact: Robert J. Hayashi 314-454-4118

United States, Oregon
	Oregon Health and Science University Cancer Institute	Recruiting
	Portland, Oregon, United States, 97239-3098
	Contact: Clinical Trials Office - Oregon Health and Science University 503-494-1080 trials@ohsu.edu

United States, Pennsylvania
	Children's Hospital of Pittsburgh	Recruiting
	Pittsburgh, Pennsylvania, United States, 15213
	Contact: Clinical Trials Office - Children's Hospital of Pittsburgh 412-692-5573

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators


Study Chair:	Anne Angiolillo, MD	Childrens Research Institute

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000594340, COG-AALL07P4
First Received:	May 1, 2008
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00671034
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

B-cell adult acute lymphoblastic leukemia

B-cell childhood acute lymphoblastic leukemia

untreated adult acute lymphoblastic leukemia

untreated childhood acute lymphoblastic leukemia

Study placed in the following topic categories:

Dexamethasone

Asparaginase

Prednisone

Daunorubicin

Leukemia, Lymphoid

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Immunoproliferative Disorders

Vincristine

Cyclophosphamide

Doxorubicin

Acute lymphoblastic leukemia, adult

Folic Acid

Pegaspargase

Leukemia

Lymphatic Diseases

Methotrexate

Lymphoproliferative Disorders

Lymphoma

Cytarabine

Dexamethasone acetate

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Antimetabolites

Anti-Infective Agents

Antimetabolites, Antineoplastic

Molecular Mechanisms of Pharmacological Action

Immunologic Factors

Antineoplastic Agents

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Antiemetics

Reproductive Control Agents

Antibiotics, Antineoplastic

Hormones

Therapeutic Uses

Abortifacient Agents

Dermatologic Agents

Alkylating Agents

Nucleic Acid Synthesis Inhibitors

Neoplasms by Histologic Type

Antineoplastic Agents, Hormonal

Immune System Diseases

Mitosis Modulators

Gastrointestinal Agents

Enzyme Inhibitors

Antimitotic Agents

Folic Acid Antagonists

Abortifacient Agents, Nonsteroidal

Immunosuppressive Agents

Antiviral Agents

Glucocorticoids

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	Children's Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00671034