New Retinoid Agent Combined With Arsenic Trioxide for Untreated Acute Promyelocytic Leukemia

This study has been withdrawn prior to enrollment.
(sponsor withdrew support)
Sponsor:
Collaborator:
Sponsor Name Pending
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT00670150
First received: April 28, 2008
Last updated: September 23, 2010
Last verified: September 2010
  Purpose

The safety and efficacy of combining NRX 195183 with arsenic trioxide in treating untreated APL will be assessed.


Condition Intervention Phase
Acute Promyelocytic Leukemia
Drug: NRX 195183 (retinoid analogue)
Drug: Arsenic Trioxide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of NRX 195183 Induction and NRX 195183 Combined With Arsenic Trioxide (As2o3) as Initial Consolidation Therapy Followed by Continuous NRX 195183 Maintenance Therapy for Patients With Untreated Acute Promyelocytic Leukemia

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • The primary endpoint is achieving a partial or complete response [ Time Frame: Bone marrow biopsies will be done monthly during induction ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and feasibility [ Time Frame: Twice weekly during induction and then weekly during consolidation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: May 2010
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: NRX 195183 (retinoid analogue)
    30mg/m2 PO daily x 3mo.in Induction, then daily with consolidation
    Drug: Arsenic Trioxide
    0.15mg/kg/day over 2hrs VI on day 1-5 x 4 weeks. 2 weeks rest then repeat x 3 more cycles.
Detailed Description:

The primary objectives of this study are in newly diagnosed APL patients:

  • To evaluate the efficacy (complete and molecular response rates) and toxicity of NRX 195183 in induction therapy
  • To evaluate the efficacy (molecular response rates) and toxicity of NRX 195183 in combination with arsenic trioxide (As2O3) in consolidation therapy.
  • To evaluate the efficacy (event free-survival, disease-free survival) and toxicity of NRX 195183 as maintenance therapy for patients with APL who achieve a molecular complete response.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis Patients must have a clinical diagnosis of acute promyelocytic leukemia (APL) morphology or FAB M3 variant confirmed by RT-PCR assay for PML-RARα or chromosome analysis/FISH showing t(15:17) translocation. A patient may be entered prior to confirmatory studies, but a patient who is subsequently found to be PML-RARα negative will be removed from protocol treatment.
  • Prior Treatment The patient must not have received any systemic definitive treatment for APL, including cytotoxic chemotherapy, retinoids or arsenic trioxide. Prior therapy with corticosteroids, hydroxyurea or leukapheresis will not exclude the patient.
  • Age: Patients must be of age eighteen (18) or above.
  • Other Criteria

    • Patients must have the following laboratory values:

      • Bilirubin equal or less than 1.5 times the upper limit of normal.
      • Creatinine equal or less than 1.5 times the upper limit of normal
  • Pregnancy / Nursing Status

    • Patients entered into this study should be non-pregnant and non-nursing and should not plan on becoming pregnant while on treatment. Treatment under this protocol would expose an unborn child to significant risks. treatment. Women and men of reproductive potential should agree to use an effective means of birth control. There is an extremely high risk of fetal malformation if pregnancy occurs while on treatment in any amount with retinoid drugs even for short periods.

Exclusion Criteria:

  • Non-APL, AML patients should be excluded from the study.
  • Other serious illnesses which would limit survival to 1 year.
  • Psychiatric conditions which would prevent compliance with treatment or informed consent.
  • Uncontrolled or severe cardiovascular disease. This would include history of a recent acute myocardial infarction, uncontrolled congestive heart failure, or active angina.
  • AIDS or HIV positive patients, although HIV test is not required for accrual.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670150

Locations
United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Sponsor Name Pending
Investigators
Principal Investigator: Dan Douer, MD University of Southern California
  More Information

No publications provided

Responsible Party: Dr. Dan Douer, University of Southern California
ClinicalTrials.gov Identifier: NCT00670150     History of Changes
Other Study ID Numbers: 9L-07-12
Study First Received: April 28, 2008
Last Updated: September 23, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Arsenic trioxide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014