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A Phase 2 Study of Temozolomide Plus Vorinostat for Elderly Patients (>60) With Newly Diagnosed Acute Myeloid Leukemia (AML) or Relapse/Refractory AML

Phase 2
18 Years
Open (Enrolling)
Acute Myeloid Leukemia With 11q23-abnormality in Relapse

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Trial Information

A Phase 2 Study of Temozolomide Plus Vorinostat for Elderly Patients (>60) With Newly Diagnosed Acute Myeloid Leukemia (AML) or Relapse/Refractory AML

Inclusion Criteria:

- Female patient of childbearing potential has a negative serum pregnancy test beta-hCG
within 72 hours prior to receiving the first dose of vorinostat.

- Female patient is either post menopausal, free from menses for > 2 years, surgically
sterilized or willing to use 2 adequate barrier methods of contraception to prevent
pregnancy or agrees to abstain from heterosexual activity throughout the study,
starting with Visit 1.

- Male patient agrees to use an adequate method of contraception for the duration of
the study and 1 month following coming off study or of study completion.

- Patient, or the patient's legal representative, has voluntarily agreed to participate
by giving written informed consent.

- Patient is >=18 years of age on day of signing informed consent.

- Patient is available for periodic blood sampling, study related assessments, and
management at the treating institution for the duration of the study.

Exclusion Criteria:

- Patient who has had chemotherapy, radiotherapy, or biological therapy within 30 days
(42 days for nitrosoureas or mitomycin C) prior to initial dosing with study
drug(s)or who has not recovered from adverse events due to agents administered more
than 30 days earlier, except for hydroxyurea.

- Patient is currently participating or has participated in a study with an
investigational compound or device within 30 days of initial dosing with study

- Patient had prior treatment within the past 30 days with an HDAC inhibitor (e.g.,
romidepsin (Depsipeptide), NSC-630176, MS 275, LAQ-824, belinostat (PXD-101), LBH589,
MGCD0103, CRA024781, etc). Patients who have received compounds with HDAC
inhibitor-like activity, such as valproic acid, as anti-tumor therapy should not
enroll in this study. Patients who have received such compounds for other
indications, e.g. valproic acid for epilepsy, may enroll after a 30-day washout

- Patients may not be receiving any other investigational agents.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to temozolomide or DTIC or vorinostat.

- History of gastrointestinal disease or significant bowel resection that could
interfere with drug absorption.

- Uncontrolled intercurrent illness (as defined by the investigators) including, but
not limited to, ongoing or active infection (HIV, Hepatitis B or Hepatitis C),
symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia,
or psychiatric illness/social situations that would limit compliance with study

- Prior allogeneic stem cell transplantation within 2 months of trial enrollment.

Inability to swallow tablets.

- Prior radiation up to more than 25% of bone marrow.

- Pregnancy or lactation (2 negative pregnancy test and two methods of contraception of
abstinence required).

- Prior HDAC inhibitor within 30 days of initiating trial therapy as listed above.
Concomitant radiotherapy, chemotherapy, or immunotherapy.

Exclusion Criteria Based on Medical History or Current Medical Status

- Patient has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.

Patient is, at the time of signing informed consent, a regular user (including
"recreational use") of any illicit drugs, substance abuse or had a recent history (within
the last year) of drug or alcohol abuse.

Patient is pregnant or breast feeding, or expecting to conceive or father children within
the projected duration of the study.

Patient with a "currently active" second malignancy, other than nonmelanoma skin cancer
and carcinoma in situ of the cervix, should not be enrolled. Patients are not considered
to have a "currently active" malignancy if they have completed therapy for a prior
malignancy, are disease free from prior malignancies for >5 years or are considered by
their physician to be at less than 30% risk of relapse.

- Patient has an active infection or has received intravenous antibiotics, antiviral, or
antifungal agents within 2 weeks prior to the start of the study drug.

Patient has uncontrolled intercurrent illness or circumstances that could limit compliance
with the study, including, but not limited to the following: active infection, acute or
chronic graft versus host disease, symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, or psychiatric conditions.

Patient has a history or current evidence of any condition, therapy, or lab abnormality
that might confound the results of the study, interfere with the patient's participation
for the full duration of the study or is not in the best interest of the patient to

Patient has a history of a gastrointestinal surgery or other procedures that might, in the
opinion of the investigator, interfere with the absorption or swallowing of the study

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of morphological complete remission

Outcome Description:

The primary endpoint of the study is to determine the clinical efficacy, as determined by the rate of morphological complete remission, of 2 different treatment regimens of temozolomide and vorinostat in patients with AML and poor prognostic features.

Outcome Time Frame:

36 months

Safety Issue:


Principal Investigator

Bruno Carneiro de Medeiros, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Food and Drug Administration

Study ID:




Start Date:

May 2013

Completion Date:

April 2016

Related Keywords:

  • Acute Myeloid Leukemia With 11q23-abnormality in Relapse
  • Congenital Abnormalities
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Recurrence



Stanford University Cancer InstituteStanford, California  94305