Methotrexate, Vincristine, Pegylated L-Asparaginase and Dexamethasone (MOAD) in Acute Lymphoblastic Leukemia (ALL) Salvage - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00905034

Purpose

The goal of this clinical research study is to learn if the combination of methotrexate, pegylated-L-asparaginase, vincristine, and dexamethasone (MOAD) [also rituximab in some patients] can help to control acute lymphoblastic leukemia (ALL) that has not responded to previous treatment or has come back after a response.

Condition	Intervention	Phase
Leukemia, Lymphocytic, Acute	Drug: Methotrexate Drug: Vincristine Drug: PEG-l-asparaginase Drug: Dexamethasone Drug: Rituximab	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of Methotrexate, Vincristine, Pegylated L-asparaginase and Dexamethasone (MOAD) in Acute Lymphoblastic Leukemia (ALL) Salvage

Resource links provided by NLM:

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

Drug Information available for: Dexamethasone Vincristine Methotrexate Ethanol, 2,2'-(oxybis(2,1-ethanediyloxy)bis- Dexamethasone acetate Doxiproct plus Pegaspargase Rituximab Dexamethasone Sodium Phosphate Vincristine sulfate L-Asparaginase

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Complete Response (CR) Rate Defined as Number of Participants Who Achieve a Complete Response [ Time Frame: Baseline to 6 cycles (cycle = 28 days) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	May 2009
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
MOAD: Experimental Chemotherapy regimen of methotrexate, vincristine, pegylated L-asparaginase and dexamethasone (MOAD)	Drug: Methotrexate 200 mg/m^2 by vein on days 1 and 15. Drug: Vincristine 1.4 mg/m^2 by vein (maximum dose 2 mg) on days 1, 8 and 15. Drug: PEG-l-asparaginase 2500 International units/m^2 by vein on days 2 and 16 Drug: Dexamethasone 40 mg by vein or by mouth daily days 1-4 and 15-18. Drug: Rituximab Rituximab 375 mg/m^2 by vein on days 1 and 15 (first 4 cycles) for patients CD20 positive or positive by immunostain.

Arms

Assigned Interventions

MOAD: Experimental

Chemotherapy regimen of methotrexate, vincristine, pegylated L-asparaginase and dexamethasone (MOAD)

Drug: Methotrexate

200 mg/m^2 by vein on days 1 and 15.

Drug: Vincristine

1.4 mg/m^2 by vein (maximum dose 2 mg) on days 1, 8 and 15.

Drug: PEG-l-asparaginase

2500 International units/m^2 by vein on days 2 and 16

Drug: Dexamethasone

40 mg by vein or by mouth daily days 1-4 and 15-18.

Drug: Rituximab

Rituximab 375 mg/m^2 by vein on days 1 and 15 (first 4 cycles) for patients CD20 positive or positive by immunostain.

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Previously treated ALL (including Burkitt's lymphoma) or lymphoblastic lymphoma in relapse or primary refractory; without viable stem cell transplant option;
Zubrod performance status </= 3;
Adequate liver function (bilirubin </= 3.0mg/dl, unless considered due to tumor),and renal function (creatinine </= 3.0 mg/dl unless considered due to tumor;
Age >/= to 1 year
Understand and voluntarily sign an informed consent form.
For pediatric patients (age >/= 1 year to </= 18 years), Lansky performance status >/=50
For pediatric patients (age >/= 1 year to </= 18 years), second or greater relapse

Exclusion Criteria:

Pregnant patients
Prior history of allergic reaction, serious pancreatitis, hemorrhagic or thrombotic event with PEG-l-asparaginase or its components.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905034

Contacts

Contact: Gautam Borthakur, M.D.

713/563-1586

gborthak@mdanderson.org

Locations

United States, Texas
The University of Texas M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Gautam Borthakur, M.D. 713-563-1586 gborthak@mdanderson.org
Principal Investigator: Gautam Borthakur, M.D.

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Gautam Borthakur, M.D.

M.D. Anderson Cancer Center

More Information

Additional Information:

M.D. Anderson's Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	The University of Texas M.D. Anderson Cancer Center ( Gautam Borthakur M.D./ Assistant Professor )
Study ID Numbers:	2008-0267
Study First Received:	May 18, 2009
Last Updated:	November 17, 2009
ClinicalTrials.gov Identifier:	NCT00905034 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Acute lymphoblastic leukemia
ALL
Leukemia
Methotrexate
Vincristine
PEG-l-asparaginase
PEG asparaginase

Pegaspargase
Oncaspar
Polyethylene Glycol Conjugated Lasparaginase-H
Dexamethasone
Decadron
Rituximab
Rituxan

Additional relevant MeSH terms:

Antimetabolites
Anti-Inflammatory Agents
Dexamethasone
Leukemia, Lymphoid
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Reproductive Control Agents
Hormones
Pegaspargase
Leukemia

Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Dexamethasone acetate
Asparaginase
Immunoproliferative Disorders
Neoplasms by Histologic Type
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Antineoplastic Agents, Hormonal
Immune System Diseases
Rituximab
Mitosis Modulators
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 09, 2010