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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Southwest Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00840177
First received: February 7, 2009
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Pravastatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Pravastatin may also help idarubicin and cytarabine work better by making cancer cells more sensitive to the drugs. Giving idarubicin and cytarabine together with pravastatin may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving idarubicin and cytarabine together with pravastatin works in treating patients with relapsed acute myeloid leukemia.


Condition Intervention Phase
Leukemia
Drug: cytarabine
Drug: idarubicin
Drug: pravastatin sodium
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: S0919, A Phase II Study of Idarubicin and Ara-C in Combination With Pravastatin for Relapsed Acute Myelogenous Leukemia (AML)

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Complete remission (CR) rate (including CR with incomplete recovery) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Relapse-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI CTCAE version 4.0 [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Correlation between pre-study cytogenetic features and response [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: August 2009
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment

Induction (1 cycle):

pravastatin 1280 mg/d PO D 1-8 idarubicin 12 mg/m2/d IV D 4-6 AraC 1.5 g/m2/d contIV D 4-7

Consolidation (up to 2 cycles):

pravastatin 1280 mg/d PO D 1-6 idarubicin 12 mg/m2/d IV D 4-5 AraC 1.5 g/m2/d contIV D 4-5

Drug: cytarabine Drug: idarubicin Drug: pravastatin sodium

Detailed Description:

OBJECTIVES:

  • To test whether the complete remission (CR) rate (including CR with incomplete recovery) in patients with relapsed acute myeloid leukemia treated with idarubicin and cytarabine in combination with pravastatin is sufficiently high to warrant a phase III investigation.
  • To estimate relapse-free survival and overall survival rates in these patients.
  • To estimate the frequency and severity of toxicities of this regimen in these patients.
  • To evaluate, in a preliminary manner, whether pre-study cytogenetic features correlate with response in these patients.

OUTLINE: This is a multicenter study.

  • Induction therapy: Patients receive oral pravastatin once daily on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Patients achieving complete remission proceed to consolidation therapy.
  • Consolidation therapy: Beginning 30-60 days after the start of induction therapy, patients receive oral pravastatin once daily on days 1-6 and idarubicin IV over 10-15 minutes and cytarabine IV continuously on days 4 and 5. Treatment repeats approximately every 5 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Morphologically confirmed diagnosis of acute myeloid leukemia (AML)
  • Must have received ≥ 1 prior chemotherapy regimen for AML

    • Any type of prior chemotherapy allowed
    • Must have achieved a complete remission (CR) (including CR with incomplete recovery) that lasted ≥ 3 months after the last induction regimen and then subsequently relapsed

      • Relapse must be documented by a bone marrow examination demonstrating > 5% blasts in the bone marrow not attributable to another cause
  • No acute promyelocytic leukemia (i.e., APL, FAB M3) or blastic transformation of chronic myelogenous leukemia
  • No clinical evidence of leptomeningeal disease
  • Concurrent registration on research study SWOG-9007 required

PATIENT CHARACTERISTICS:

  • 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
  • Ejection fraction ≥ 45% by echocardiogram or MUGA scan
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No symptomatic congestive heart failure, coronary artery disease, cardiomyopathy, or uncontrolled arrhythmias
  • 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
  • Other prior malignancy allowed provided patient is in remission from that malignancy

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 6 months since prior chemotherapy or radiotherapy and recovered
  • No prior autologous or allogeneic stem cell transplantation
  • Prior or concurrent hydroxyurea to control high WBC counts allowed
  • No concurrent statin treatments
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840177

Contacts
Contact: Sandi J Fredette 2106148808 ext 1002 sfredette@swog.org
Contact: Dana Sparks, MAT 2106148808 ext 1004 dsparks@swog.org

  Show 85 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Anjali Advani, MD The Cleveland Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00840177     History of Changes
Other Study ID Numbers: CDR0000633749, S0919, U10CA032102
Study First Received: February 7, 2009
Last Updated: April 4, 2014
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
recurrent adult acute myeloid leukemia
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type
Cytarabine
Idarubicin
Pravastatin
Anti-Infective Agents
Antibiotics, Antineoplastic
Anticholesteremic Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Immunologic Factors
Immunosuppressive Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014