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 (Initial cohort: Relapsed AML with previous remission >/= 3 months) is permanently
closed to accrual DISEASE CHARACTERISTICS

   - Patients must have a previous morphologically confirmed diagnosis of acute myeloid
   leukemia (AML). Note: This protocol uses the World Health Organization (WHO)
   diagnostic criteria for acute myeloid leukemia (AML) (see Section 4.1). Patients with
   acute promyelocytic leukemia (APL, FAB, M3) or blastic transformation of chronic
   myelogeneous leukemia (CMML) are not eligible.

   - Patients must have received at least one prior chemotherapy regimen for their acute
   myeloid leukemia (AML) and they may have received any type of chemotherapy. They must
   have achieved complete remission (CR), lasting at least three months with their last
   induction regimen and they must have relapsed after the last regimen. Relapse must be
   documented by a bone marrow examination demonstrating > 5% blasts in the bone marrow
   not attributable to another cause. Refractory patients and patients who have received
   autologous or allogeneic stem cell transplantation are not eligible. Administration of
   hydroxyurea to control high white blood cell (WBC) count prior to, during and after
   registration is permitted.

   - Patients must not have symptomatic congestive heart failure, coronary artery disease,
   cardiomyopathy, or uncontrolled arrhythmias. Either an echocardiogram or
   multiple-gated acquisition (MUGA) scan with an ejection fraction ≥ 45% must be
   obtained within 28 days prior to registration. (Either method for measuring cardiac
   function is acceptable, however, the same scan must be used throughout treatment and
   follow-up to monitor the patient for cardiac toxicity.) If patient has symptoms
   suggestive of ischemia or congestive heart failure after that cardiac evaluation was
   done, a repeat study must be obtained prior to registration.

   - Patients must have a serum creatinine < 2.0 mg/dl within 14 days prior to
   registration.

   - Patients must have a total bilirubin ≤ 2.0 x Institutional Upper Limit of Normal
   (IULN) within 14 days prior to registration, unless the elevation is due primarily to
   elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis
   and not to liver dysfunction.

   - Patients must have SGOT (AST) ≤ 3.0 x IULN and SGPT (ALT) ≤ 3.0 x IULN within 14 days
   prior to registration. Treatment may begin with SGOT/SGPT above those limits, if the
   abnormalities are thought to be due to the patient's leukemia.

   - Patients must have Zubrod performance status of 0-2 (see Section 10.8).

   - Patients must be ≥ 18 years of age.

   - Patients must not have clinical evidence of leptomeningeal disease (a spinal tap does
   not need to be performed).

   - Patients not known to be HIV+ must be tested for HIV infection (the human
   immunodeficiency virus) within 14 days prior to registration (see Section 2.0 for
   justification). Patients who are HIV+ may be eligible providing they meet all of the
   following additional criteria within 14 days prior to registration:

      1. Patient must have no history of AIDS defining events.

      2. CD4 cells ≥ 500/mm3.

      3. Viral load of < 50 copies HIV mRNA/mm3 if on cART or < 25,000 copies HIV mRNA if
      not on cART.

      4. No zidovudine or stavudine as part of cART. Patients who are HIV+ and do not meet
      all of these criteria will not be eligible for this study.

   - Patients with prior malignancy (other than AML) are eligible. However, the patient
   must be in remission from the prior malignancy and have completed all chemotherapy and
   radiotherapy at least 6 months prior to registration and all treatment related
   toxicities must have been resolved. NOTE: For patients with prior history of
   malignancy who have received anthracyclines or mediastinal/pericardial radiation in
   the past, the risk versus benefit of therapy should be weighed, particularly in the
   setting of receiving consolidation therapy.

   - Patients must not have a systemic fungal, bacterial, viral or other infection that is
   not controlled (defined as exhibiting ongoing signs/symptoms related to the infection
   and without improvement, despite appropriate antibiotics or other treatment).

   - Southwest Oncology Group patients must be registered on SWOG-9007 ("Cytogenetic
   Studies in Leukemia Patients"). Collection of pretreatment marrow specimens must be
   completed within 28 days prior to registration. Pretreatment specimens of bone marrow
   (or peripheral blood if the marrow aspirate is a dry tap) must be submitted to an
   approved Southwest Oncology Group Cytogenetics Laboratory for cytogenetics analysis.
   Note that protocol SWOG-9007 also requires submission of specimens at additional
   timepoints.

   - Southwest Oncology Group patients must be offered participation in S9910 ("Leukemia
   Centralized Reference Laboratories and Tissue Repositories Ancillary"). If consent is
   given, collection of pretreatment blood and/or marrow specimens must be completed
   within 28 days prior to registration. If the patient consents to participate in S9910,
   pretreatment specimens of marrow and/or peripheral blood must be submitted to the
   Southwest Oncology Group Myeloid Repository at the University of New Mexico for
   cellular and molecular studies. Note that protocol S9910 also requests submission of
   specimens at additional timepoints.

   - Women of reproductive potential must have a negative pregnancy test within 14 days
   prior to registration. Patients must not be pregnant or nursing because of the
   teratogenic potential of the drugs used in this study. Women/men of reproductive
   potential must have agreed to use an effective contraceptive method.

   - All patients must be informed of the investigational nature of this study and must
   sign and give written informed consent in accordance with institutional and federal
   guidelines.

   - At the time of patient registration, the treating institution's name and ID number
   must be provided to the Data Operations Center in Seattle in order to ensure that the
   current (within 365 days) date of institutional review board approval for this study
   has been entered into the data base.

Cohort 2 (MDS transformed to AML) is permanently closed to accrual AND Cohort 3
(relapsed/refractory AML) is permanently closed to accrual

DISEASE CHARACTERISTICS:

   - For patients registered to relapsed/refractory (Cohort 3), morphologically confirmed
   diagnosis of acute myeloid leukemia (AML)

   - Patient registered to the myelodysplastic syndrome (MDS) transformed to acute myeloid
   leukemia (AML) cohort (Cohort 2) patients must have a previous morphologically
   confirmed diagnosis of myelodysplastic syndrome/chronic myelomonocytic leukemia
   (MDS/CMML). Patients may have received previous non-intensive therapy (such as:
   azacitadine, decitabine, low-dose cytarabine, lenalidomide) given treatment of
   myelodysplastic syndrome/chronic myelomonocytic leukemia (MDS/CMML) (with up to 20%
   blasts). At time of registration, patient must have morphologically confirmed
   diagnosis of acute myeloid leukemia (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 acute myeloid leukemia (AML) cohort (Cohort 3)
   must:

      - Have received ≥ 1 prior chemotherapy regimen for acute myeloid leukemia (AML)

         - Any type of prior chemotherapy allowed

         - Administration of hydroxyurea to control high white blood cell (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 acute myeloid leukemia (AML) and myelodysplastic syndrome (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