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

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

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 Radiation: radiation therapy

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 (ALL)

Resource links provided by NLM:

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

Drug Information available for: Dexamethasone Cyclophosphamide Prednisone Vincristine Methotrexate Cytarabine hydrochloride Daunorubicin Doxorubicin Daunorubicin hydrochloride Doxorubicin hydrochloride Dexamethasone acetate Doxiproct plus Myocet Pegaspargase Cytarabine Dexamethasone Sodium Phosphate Vincristine sulfate L-Asparaginase

U.S. FDA Resources

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:	186
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 Radiation: 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 Radiation: radiation therapy Some patients undergo cranial radiotherapy

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

Radiation: 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

Radiation: 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
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, 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, Michigan
Barbara Ann Karmanos Cancer Institute	Recruiting
Detroit, Michigan, United States, 48201-1379
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute 313-576-9363
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, New Jersey
Hackensack University Medical Center Cancer Center	Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Clinical Trials Office - Hackensack University Medical Center 201-996-2879
United States, Oklahoma
Oklahoma University Cancer Institute	Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Rene Y. McNall-Knapp 405-271-5311
United States, Oregon
Knight Cancer Institute at Oregon Health and Science University	Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea 503-494-1080 trials@ohsu.edu
United States, Pennsylvania
Children's Hospital of Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19104-9786
Contact: Richard Aplenc 267-426-7252
Children's Hospital of Pittsburgh	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Clinical Trials Office - Children's Hospital of Pittsburgh 412-692-5573
United States, Tennessee
Vanderbilt-Ingram Cancer Center	Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480
United States, Washington
Children's Hospital and Regional Medical Center - Seattle	Recruiting
Seattle, Washington, United States, 98105
Contact: Julie R. Park 206-987-2106

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Anne Angiolillo, MD

Children's Research Institute

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000594340, COG-AALL07P4
Study First Received:	May 1, 2008
Last Updated:	November 7, 2009
ClinicalTrials.gov Identifier:	NCT00671034 History of Changes
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

Additional relevant MeSH terms:

Dexamethasone
Anti-Inflammatory Agents
Prednisone
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Pegaspargase
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents

Nucleic Acid Synthesis Inhibitors
Asparaginase
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Hormonal
Vincristine
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Doxorubicin
Neoplasms
Antineoplastic Agents, Phytogenic
Antimetabolites
Daunorubicin
Leukemia, Lymphoid

ClinicalTrials.gov processed this record on November 09, 2009