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Tretinoin and Arsenic Trioxide With or Without Idarubicin in Treating Patients With Acute Promyelocytic Leukemia

This study has been terminated.
(Lack of accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00528450
First Posted: September 12, 2007
Last Update Posted: January 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
Cephalon
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
  Purpose

RATIONALE: Tretinoin may help cancer cells become more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as arsenic trioxide and idarubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving tretinoin together with arsenic trioxide with or without idarubicin may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving tretinoin together with arsenic trioxide with or without idarubicin works in treating patients with acute promyelocytic leukemia.


Condition Intervention Phase
Leukemia Drug: arsenic trioxide Drug: idarubicin Drug: tretinoin Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Combined All-Trans Retinoic Acid and Arsenic Trioxide for Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • Molecular Remission Rate [ Time Frame: 2 years ]
    # of patients with Complete Remission


Enrollment: 1
Study Start Date: September 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tretinoin and Arsenic Trioxide With or Without Idarubicin
See Outline for details
Drug: arsenic trioxide Drug: idarubicin Drug: tretinoin

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Morphologic diagnosis of acute promyelocytic leukemia (APL), confirmed by one of the following:

    • Demonstration of t(15;17) using conventional cytogenetics or fluorescence in situ hybridization (FISH)
    • Positive PML-RARα transcript by reverse transcriptase-polymerase chain reaction (RT-PCR) assay
  • Patients with CNS involvement by APL are eligible

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%
  • Creatinine ≤ 2.0 mg/dL or creatinine clearance > 60 mL/min
  • Bilirubin < 2.0 mg/dL (unless attributed to Gilbert disease)
  • Alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 ULN
  • LVEF ≥ 50% on echocardiogram or MUGA scan
  • QTc ≤ 500 msec on baseline ECG
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 4 months after the completion of study treatment
  • No active serious infections not controlled by antibiotics
  • No other concurrent active malignancy requiring immediate therapy
  • No clinically significant cardiac disease (New York Heart Association class III or IV heart disease), including chronic arrhythmias
  • No pulmonary disease
  • No other serious or life-threatening condition deemed unacceptable by the principal investigator

PRIOR CONCURRENT THERAPY:

  • No prior treatment for APL
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00528450


Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Cephalon
Investigators
Principal Investigator: Joseph G. Jurcic, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Peter Maslak, MD Memorial Sloan Kettering Cancer Center
  More Information

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00528450     History of Changes
Other Study ID Numbers: 07-108
P30CA008748 ( U.S. NIH Grant/Contract )
MSKCC-07108
CEPHALONO-MSKCC-07108
First Submitted: September 10, 2007
First Posted: September 12, 2007
Results First Submitted: December 23, 2015
Results First Posted: January 29, 2016
Last Update Posted: January 29, 2016
Last Verified: December 2015

Keywords provided by Memorial Sloan Kettering Cancer Center:
adult acute promyelocytic leukemia (M3)
adult acute myeloid leukemia with t(15;17)(q22;q12)
untreated adult acute myeloid leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Idarubicin
Arsenic trioxide
Tretinoin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Keratolytic Agents
Dermatologic Agents