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NCT00096122 · REGISTRY CONDITION SEARCH

Idarubicin, Cytarabine, and Tipifarnib in Treating Patients With Newly Diagnosed Myelodysplastic Syndromes or Acute Myeloid Leukemia

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2014-05-26

This phase I/II trial is studying the side effects and best dose of tipifarnib when given with idarubicin and cytarabine and to see how well it works in treating patients with newly diagnosed myelodysplastic syndromes or acute myeloid leukemia. Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Tipifarnib (Zarnestra) may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Giving idarubicin and cytarabine with tipifarnib may kill more cancer cells.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Complete Response

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Diagnosis of 1) AML (WHO classification definition of \> 20% blasts), or 2) high risk MDS (defined as the presence of \> 10% blasts) * Patients must be chemo-naïve, i.e. not have received any prior chemotherapy (except hydrea) for AML or MDS; they could have received transfusions, hematopoietic growth factors or vitamins; temporary measures such as pheresis or hydrea (0.5 to 5g daily for up to 3 days) are allowed * ECOG PS of 0-1 at screening * Creatinine =\< 2 mg/dl * Total bilirubin =\< 2 mg/dL, unless increase is due to hemolysis * Transaminases (SGPT) =\< 2.5 x ULN * Ability to take oral medication * Ability to understand and provide signed informed consent Exclusion Criteria: * Subjects with APL * Presence of active systemic infection * Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results * Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, IUD, diaphragm, abstinence, or condoms by their partner) over the entire course of the study * Known allergy to imidazole drugs (such as clotrimazole, ketoconazole, miconazole, econazole, fenticonazole, isoconazole, sulconazole, tioconazole, terconazole)
healthy Volunteers
false
maximum Age
70 Years
minimum Age
15 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    See Detailed Description
    intervention Names
    1. Drug: cytarabine
    2. Drug: idarubicin
    3. Drug: tipifarnib
    label
    Arm I
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm I
    description
    Given IV
    name
    cytarabine
    other Names
    1. ARA-C
    2. arabinofuranosylcytosine
    3. arabinosylcytosine
    4. Cytosar-U
    5. cytosine arabinoside
    type
    DRUG
  2. arm Group Labels
    1. Arm I
    description
    Given IV
    name
    idarubicin
    other Names
    1. 4-demethoxydaunorubicin
    2. 4-DMDR
    3. DMDR
    4. IDA
    type
    DRUG
  3. arm Group Labels
    1. Arm I
    description
    Given orally
    name
    tipifarnib
    other Names
    1. R115777
    2. Zarnestra
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
95
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Complete Response (CR) is required bone marrow blasts ≤5% and recovery of normal hematopoiesis with an absolute neutrophil count (ANC) of 1\*10\^9/L or more and platelet count of 100\*10\^9/L or more; and a complete response without platelets (CRp) is the same criteria as CR but with platelet counts from 20\*10\^9/L to less than 100\*10\^9/L.
    measure
    Number of Participants With Complete Response
    time Frame
    21 Day Cycle
Full study description
brief Summary
This phase I/II trial is studying the side effects and best dose of tipifarnib when given with idarubicin and cytarabine and to see how well it works in treating patients with newly diagnosed myelodysplastic syndromes or acute myeloid leukemia. Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Tipifarnib (Zarnestra) may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Giving idarubicin and cytarabine with tipifarnib may kill more cancer cells.
detailed Description
PRIMARY OBJECTIVES: I. To determine the tolerability of the combination of R115777 (Zarnestra™) and Idarubicin plus cytarabine by defining the DLT and MTD. (Phase I) II. To determine the efficacy of the combination of Idarubicin, cytarabine and ZARNESTRA in patients with high-risk MDS and AML. (Phase II) OUTLINE: This is a dose-escalation study of tipifarnib. Patients are stratified according to age (\< 50 versus ≥ 50) and, in patients ≥ 50 years of age, cytogenetics (diploid versus unfavorable). INDUCTION THERAPY: PHASE I: Patients receive cytarabine IV continuously on days 1-3 (or 1-4), idarubicin intravenous (IV) over 1 hour on days 1-3, and oral tipifarnib twice daily on days 1-21. Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients receive escalating doses of tipifarnib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. PHASE II: Patients receive cytarabine, idarubicin, and tipifarnib as in phase I at the MTD. Patients in both phases who respond to induction therapy proceed to consolidation maintenance therapy. CONSOLIDATION MAINTENANCE THERAPY: Patients receive consolidation therapy comprising cytarabine IV continuously on days 1-3, idarubicin IV over 1 hour on days 1-2, and tipifarnib twice daily on days 1-14. Treatment repeats every 4-6 weeks for 5 courses in the absence of unacceptable toxicity. Patients then begin maintenance therapy comprising oral tipifarnib twice daily on day 1-21. Treatment repeats every 4-6 weeks for 6 courses in the absence of unacceptable toxicity.
Source references
Source notices and limitations
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      query disease state id
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    Preserved source evidence · Not medical advice