All-Trans Retinoic Acid, and Arsenic +/- Gemtuzumab and Theophylline - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00413166

Purpose

The goal of this clinical research study is to learn if starting arsenic trioxide (ATO) therapy on Day 1 rather than Day 10 is more effective in treating patients with newly-diagnosed APL. Researchers also want to learn if theophylline can help to control APL.

Condition	Intervention
Acute Promyelocytic Leukemia	Drug: All-Trans Retinoic Acid Drug: Arsenic Trioxide Drug: Gemtuzumab Ozogamicin Drug: Theophylline

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Treatment of APL With All-Trans Retinoic Acid, and Arsenic +/- Gemtuzumab and Theophylline

Resource links provided by NLM:

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

Drug Information available for: Theophylline Gemtuzumab ozogamicin Tretinoin Arsenic trioxide Theophylline sodium glycinate

U.S. FDA Resources

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

Primary Outcome Measures:

Assess if the following will improve CR rate w/o increasing toxicity in high-risk untreated APL: arsenic trioxide D1, rather than D10, of therapy, + theophylline, and administration of gemtuzumab ozogamicin if WBC rises to > 30,000 after treatment star [ Time Frame: 3/2009 ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	September 2006
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental All-Trans Retinoic Acid + Arsenic Trioxide	Drug: All-Trans Retinoic Acid All-Trans Retinoic Acid 45 mg/m2 daily Drug: Arsenic Trioxide Arsenic Trioxide 0.15mg/kg daily
2: Experimental All-Trans Retinoic Acid + Arsenic Trioxide + Gemtuzumab Ozogamicin + Theophylline	Drug: All-Trans Retinoic Acid All-Trans Retinoic Acid 45 mg/m2 daily Drug: Arsenic Trioxide Arsenic Trioxide 0.15mg/kg daily Drug: Gemtuzumab Ozogamicin Gemtuzumab Ozogamicin 9 mg/m2 day 1 Drug: Theophylline Theophylline 100mg days 1-3 200mg days 4-6 300mg days thereafter

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

A diagnosis of APL based on the presence of the PML-RAR alpha fusion gene. Documentation can be done either cytogenetically (the t (15;17) is found, as a consequence of the formation of the fusion gene) or molecularly (PCR test for t (15;17), or a positive "POD" test (12).
Provision of written informed consent.

Exclusion Criteria:

Cannot be in first trimester of pregnancy (ATRA is teratogenic)
QTC interval must not be greater than 480 milliseconds.
Taking any drugs known to prolong the QT interval. Any patient taking them who has a baseline heart rate of less than 60 beats per minute at rest would have an EKG to evaluate for QTc prolongation, if the QTc is above the limit of 480 msec then the patient would be given an option to be evaluated by cardiology.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413166

Contacts

Contact: Farhad Ravandi-Kashani,, MD

713-745-0394

fravandi@mdanderson.org

Locations

United States, Texas
The University of Texas M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Farhad Ravandi-Kashani, MD 713-745-0394 fravandi@mdanderson.org

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Farhad Ravandi-Kashani, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

MD Anderson's website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	The University of Texas M. D. Anderson Cancer Center ( Farhad Ravandi-Kashani, M.D./Associate Professor )
Study ID Numbers:	2006-0706
Study First Received:	December 15, 2006
Last Updated:	March 19, 2009
ClinicalTrials.gov Identifier:	NCT00413166 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Acute Promyelocytic Leukemia
APL
ATRA
All-Trans Retinoic Acid

Arsenic Trioxide
Theophylline
Gemtuzumab

Study placed in the following topic categories:

Vasodilator Agents
Immunologic Factors
Anti-Asthmatic Agents
Arsenic trioxide
Cardiovascular Agents
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Gemtuzumab
Keratolytic Agents
Antibodies, Monoclonal

Leukemia
Antibodies
Phosphodiesterase Inhibitors
Leukemia, Promyelocytic, Acute
Tretinoin
Peripheral Nervous System Agents
Acute Promyelocytic Leukemia
Bronchodilator Agents
Theophylline
Immunoglobulins

Additional relevant MeSH terms:

Respiratory System Agents
Vasodilator Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Leukemia, Myeloid, Acute
Keratolytic Agents
Antibodies, Monoclonal
Leukemia
Therapeutic Uses
Leukemia, Promyelocytic, Acute
Dermatologic Agents
Neoplasms by Histologic Type

Arsenic trioxide
Anti-Asthmatic Agents
Enzyme Inhibitors
Leukemia, Myeloid
Cardiovascular Agents
Gemtuzumab
Pharmacologic Actions
Neoplasms
Phosphodiesterase Inhibitors
Autonomic Agents
Tretinoin
Peripheral Nervous System Agents
Bronchodilator Agents
Theophylline

ClinicalTrials.gov processed this record on July 02, 2009