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LeukemiaPhase 1NCT00816283

Dasatinib and Vorinostat in Treating Patients With Accelerated Phase or Blastic Phase Chronic Myelogenous Leukemia or Acute Lymphoblastic Leukemia

A Phase 1 study testing dasatinib, vorinostat and cytogenetic analysis in people with Leukemia, run by City of Hope Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Dasatinib and vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving dasatinib together with vorinostat may kill more cancer cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia
What is being tested?
dasatinib, vorinostat and cytogenetic analysis
Type of treatment
Pill or oral medicine
How many people
5 participants
Where
2 sitesUnited States
Study dates
Sep 2008to Jun 2011
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following hematologic malignancies:
  • Chronic myelogenous leukemia meeting 1 of the following criteria:
  • In accelerated phase, defined by the presence of ≥ 1 of the following:
  • At least 15% but < 30% blasts in peripheral blood and/or bone marrow
  • At least 30% blasts plus promyelocytes in peripheral blood or bone marrow (providing that < 30% blasts are present in bone marrow)
  • At least 20% basophils in peripheral blood
  • Platelet count < 100,000/mm³ (unrelated to therapy) OR platelet count > 100,000/mm³ and unresponsive to therapy
  • Cytogenetic evidence of clonal evolution
  • Increasing spleen size and increasing WBC count and unresponsive to therapy
  • In blastic phase (blast crisis), defined by the presence of ≥ 1 of the following:
  • At least 30% blasts in peripheral blood and/or bone marrow
  • Extramedullary infiltrates of leukemic cells (other than liver or spleen involvement)
  • Philadelphia chromosome-positive acute lymphoblastic leukemia meeting any of the following criteria:
  • Newly diagnosed or relapsed disease
  • Previously treated with chemotherapy, stem cell transplantation, or tyrosine kinase inhibitors (TKIs)
  • No active CNS involvement

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Total bilirubin < 2.0 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • Serum sodium, potassium, magnesium, phosphate, and calcium ≥ lower limit of normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 4 weeks after discontinuation of study drug
  • Able to take oral medication
  • No active post-transplantation-related infections (e.g., fungal or viral infection)
  • No active acute graft-versus-host disease (GVHD) of any grade
  • No chronic GVHD (other than mild skin, oral, or ocular GVHD not requiring systemic immunosuppression)
  • No other malignancy that required radiotherapy or systemic treatment within the past 5 years
  • No concurrent medical condition that may increase the risk of toxicity, including pleural or pericardial effusion of any grade
  • No cardiac conditions, including any of the following:
  • Uncontrolled angina, congestive heart failure, or myocardial infarction within the past 6 months
  • Diagnosed congenital long QT syndrome
  • History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
  • Prolonged QTc interval (i.e., QTc > 450 msec) on baseline EKG
  • No hypokalemia or hypomagnesemia that cannot be corrected prior to dasatinib administration
  • No history of significant bleeding disorder unrelated to cancer, including any of the following:
  • Diagnosed congenital bleeding disorder (e.g., von Willebrand's disease)
  • Acquired bleeding disorder diagnosed within the past year (e.g., acquired anti-factor VIII antibodies)
  • Ongoing or recent (i.e., within the past 3 months) significant gastrointestinal bleeding
  • No prisoners or individuals who are compulsorily detained (i.e., involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior therapy
  • No prior HDAC inhibitors or compounds with HDAC inhibitor-like activity (e.g., valproic acid) as anti-tumor therapy
  • Prior valproic acid for the treatment of seizures allowed provided it was not given within the past 30 days
  • Prior allogeneic stem cell transplantation allowed
  • More than 4 weeks since prior chemotherapy other than TKI (6 weeks for nitrosoureas and mitomycin)
  • More than 2 weeks since prior radiotherapy
  • At least 7 days since prior and no concurrent Category I drugs that are generally accepted to have a risk of causing Torsades de pointes, including any of the following:
  • Quinidine, procainamide, or disopyramide
  • Amiodarone, sotalol, ibutilide, or dofetilide
  • Erythromycin or clarithromycin
  • Chlorpromazine, haloperidol, mesoridazine, thioridazine, or pimozide
  • Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, or lidoflazine
  • At least 7 days since prior and no concurrent medications that directly and durably inhibit platelet function, including any of the following:
  • Aspirin or aspirin-containing combinations, clopidogrel, or dipyridamole
  • Tirofiban, epoprostenol, eptifibatide, cilostazol, abciximab, ticlopidine, or cilostazol
  • At least 5 days since prior and no concurrent St. John's wort
  • No IV bisphosphonates during the first 8 weeks of dasatinib therapy

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • City of Hope Medical Group

    Pasadena, California, 91105

Other trials in United States

About this study

Official title: BMS CA180157: A Phase I Combination Study of Dasatinib Plus Vorinostat in Accelerated Phase, Chronic Phase Refractory to Second Line Therapy or Blast Crisis Chronic Myelogenous Leukemia (CML), and in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL)

RATIONALE: Dasatinib and vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving dasatinib together with vorinostat may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of dasatinib when given together with vorinostat in treating patients with accelerated phase or blastic phase chronic myelogenous leukemia or acute lymphoblastic leukemia.

Read the detailed description

OBJECTIVES:

  • To define the maximum tolerated dose of dasatinib and vorinostat in patients with accelerated phase or blastic phase chronic myelogenous leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia.
  • To assess the toxicity of this regimen in these patients.
  • To assess, preliminarily, the efficacy of this regimen in these patients.

Secondary

  • To perform correlative studies relevant to this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral dasatinib twice daily on days 1-21 and oral vorinostat twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients undergo bone marrow aspiration and blood sample collection periodically for correlative laboratory studies. Samples are assessed by RT-PCR for DNA damage response and proapoptotic elements (GADD45, FANC, and FOXO3A); cytogenetic analysis; flow cytometry; mutation analysis of bcr-abl; and gene expression array analysis.

Conditions
Leukemia
Being tested
dasatinib, vorinostat, cytogenetic analysis, gene expression analysis, mutation analysis
Keywords
accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, relapsing chronic myelogenous leukemia, Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia, recurrent adult acute lymphoblastic leukemia, untreated adult acute lymphoblastic leukemia
Medical subject headings
Leukemia, Leukemia, Myeloid, Accelerated Phase, Blast Crisis, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dasatinibDrug

    50 mg orally 2 times per day or 140 mg orally one time per day

  • vorinostatDrug

    100 mg orally 2 times per day

  • cytogenetic analysisGenetic

    Performed at the end of cycle two of treatment and every six cycles for patients with accelerated CML and every 3 cycles for patients with blast crisis or Ph+ ALL

  • gene expression analysisGenetic

    Bone marrow aspirate obtained pre-treatment, at first scheduled bone marrow assay and at relapse. Peripheral blood drawn pre-therapy, day +14 of first treatment cycle and at relapse.

  • mutation analysisGenetic

    Performed at baseline and at every bone marrow analysis on peripheral blood

  • reverse transcriptase-polymerase chain reactionGenetic

    Peripheral blood drawn prior to starting Vorinostat on Day 1 and on Day 14 of treatment

  • flow cytometryOther

    Performed at the end of cycle two of treatment and every six cycles for patients with accelerated CML and every 3 cycles for patients with blast crisis or Ph+ ALL

  • laboratory biomarker analysisOther

    Performed pre-treatment and day +14 of treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose

    Measured: 21 days after the beginning of treatment

  2. Toxicity as assessed by NCI CTCAE v3.0

    Measured: 21 days from the beginning of the last course of treatment

  3. Response rate

    Measured: One year after treatment completion

  4. Objective tumor response

    Measured: One year after treatment completion

  5. Survival

    Measured: One year after treatment completion

  6. Time to treatment failure

    Measured: One year after treatment completion

  7. Duration of response

    Measured: One year after treatment completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2009 (estimated)
  2. Study startSep 2008
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00816283
Sponsor's protocol ID
08047
Other IDs
P30CA033572, CHNMC-08047, CDR0000631569
Status last verified
Jul 2012
First submitted
31 Dec 2008
Last updated
17 Jul 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing dasatinib, vorinostat and cytogenetic analysis in people with Leukemia, run by City of Hope Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (time frame: 21 days after the beginning of treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2012.

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