Clinical trial NCT00675870: Study of NRX 195183 Therapy for Patients With Relapsed or Refractory Acute Promyelocytic Leukemia
Official title: Phase II Study of NRX 195183 Therapy for Patients With Relapsed or Refractory Acute Promyelocytic Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Promyelocytic Leukemia
Keywords: Acute Promyelocytic Leukemia
Cancer
Leukemia
APL
ATRA
Tretinoid
Vesanoid
Retinoic Acid Receptor Alpha
All Trans Retinoic Acid
Arsenic Trioxide
Trisenox
Retinoid
Relapsed or Refractory Acute Promyelocytic Leukemia
Lead sponsor: NuRx Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-05-12
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether NRX 195183 is effective in the treatment of relapsed or refractory Acute Promyelocytic Leukemia

Detailed description: A common current therapeutic approach to APL uses oral ATRA and chemotherapy in induction and consolidation. This approach has significantly improved survival in newly diagnosed APL patients. However, approximately 30% of patients relapse. Recently, an approach involving the combination of oral ATRA and arsenic trioxide has been tested. The prognosis for relapsed patients is very poor. This study seeks to investigate NRX 195183 monotherapy in patients who have failed or are resistant to or are intolerant of any prior therapy.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of APL morphology or FAB M3 variant confirmed by RT-PCR assay or chromosome analysis/FISH showing t(15:17) translocation. Patients must also have relapse from, resistance to or intolerance of any one or more of the following therapies:

  * ATRA
  * Cytotoxic chemotherapy
  * Arsenic trioxide
* Patients must be 18 or older.
* 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.
* 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. Women and men of reproductive potential should agree to use an effective means of birth control. There is an extremely high risk that a severely deformed infant will result if NRX 195183 is administered during pregnancy.

Exclusion Criteria:

* Non-APL, AML patients should be excluded from the study.
* Other serious illnesses which would limit survival to 6 months.
* 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.

Primary outcomes:
measure: Complete Remission
timeFrame: 90 Days
Secondary outcomes:
measure: Molecular Complete Remission
timeFrame: 9 months
Other outcomes:
Locations:
city: Santa Monica,
country: United States
facility: Sarcoma Oncology Center
state: California
Study officials:
References: