Trial Search Results

S0919 Idarubicin, Cytarabine, and Pravastatin in Treating Patients With Relapsed Acute Myeloid Leukemia

The purpose of this study is to find out what effects, good and/or bad, the combination of regular chemotherapy plus pravastatin has on Relapsed Acute Myelogenous Leukemia (AML) patients. The chemotherapy is made up of two drugs which are commonly used to treat your type of leukemia. These drugs are Idarubicin and ARA-C (Cytarabine). Pravastatin is a drug that is usually used to treat high cholesterol. We would like to see whether adding Pravastatin to the chemotherapy will have an effect. Since Pravastatin is not usually used to treat leukemia, it will be considered investigational for this study.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Southwest Oncology Group

Collaborator: National Cancer Institute (NCI)

Intervention(s):

  • Drug: cytarabine
  • Drug: idarubicin
  • Drug: pravastatin sodium

Phase:

Phase 2

Eligibility


Cohort 1 (MDS transformed to AML) is open to accrual

Cohort 2 (relapsed/refractory AML) is permanently closed to accrual

DISEASE CHARACTERISTICS:

   - For patients registered to relapsed/refractory (Cohort 2), morphologically confirmed
   diagnosis of acute myeloid leukemia (AML)

   - Patient registered to the MDS transformed to AML cohort (Cohort 1) patients must have
   a previous morphologically confirmed diagnosis of MDS/CMML. Patients may have received
   previous non-intensive therapy (such as: azacitadine, decitabine, low-dose cytarabine,
   lenalidomide) given treatment of MDS/CMML (with up to 20% blasts). At time of
   registration, patient must have morphologically confirmed diagnosis of AML.

   - Patients with acute promyelocytic leukemia (i.e., APL, FAB M3) or blastic
   transformation of chronic myelogenous leukemia are not eligible

   - Patients mus not have received autologous or allogeneic stem cell transplant.

   - Patients in the relapsed/refractory AML cohort (Cohort 2) must:

      - Have received ≥ 1 prior chemotherapy regimen for AML

         - Any type of prior chemotherapy allowed

         - Administration of hydroxyurea to control high WBC prior to, during, and
         after registration is permitted

      - Relapse must be documented by a bone marrow examination demonstrating > 5% blasts
      in the bone marrow not attributable to another cause

      - Patient must not have received chemo within 14 days prior to registration

   - Primary refractory patients eligible if, on Day 14 of previous chemo regimen, they
   have significant residual disease. Patients who received only hypomethylating agent or
   low dose therapy for Induction are not considered primary refractory for this study
   and are not eligible.

   - Relapsed patients must have achieved a complete remission (CR) or CR with incomplete
   blood count recovery that lasted < 6 months after the last induction regimen

   - No clinical evidence of leptomeningeal disease

   - Pretreatment (collected within 28 days of registration) cytogenetics must be performed
   on all patients.

   - Patients must have complete history and physical exam within 28 days prior to
   registration.

PATIENT CHARACTERISTICS:

   - No symptomatic congestive heart failure, coronary artery disease, cardiomyopathy, or
   uncontrolled arrhythmias

      - Ejection fraction ≥ 45% by echocardiogram or MUGA scan within 28 days prior to
      registration (or within 14 days prior to registration if the patient has received
      anthracycline in the 28 day window)

   - Zubrod performance status 0-2

   - Serum creatinine ≤ 2.0 times upper limit of normal (ULN)

   - Total bilirubin ≤ 2.0 times ULN (unless elevation is primarily due to elevated
   unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis AND not
   due to liver dysfunction)

   - AST and ALT ≤ 3.0 times ULN

   - Not pregnant or nursing and negative pregnancy test within 14 days prior to
   registration. Females of child-bearing potential must agree to use effective
   contraception

   - No HIV positivity unless the following criteria are met:

      - No history of AIDS-defining events

      - CD4 count ≥ 500/mm³

      - Viral load < 25,000 copies (< 50 copies if on combination antiretroviral therapy)

      - Not receiving zidovudine or stavudine as part of combination antiretroviral
      therapy

   - No uncontrolled systemic fungal, bacterial, viral, or other infection, defined as
   exhibiting ongoing signs/symptoms related to the infection with no improvement despite
   appropriate antibiotics or other treatment

   - Patients with prior malignancy (other than AML and MDS/CMML) eligible provided patient
   is in remission from that malignancy at least 6 months prior to registration. Except
   for AML and MDS treatment, all treatment related toxicities must have been resolved.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting