Trial Search Results

Phase II Temozolomide + Vorinostat in Patients With Relapse/Refractory AML

The purpose of the study is to first determine if Temozolomide plus Vorinostat in combination can control relapsed or refractory AML and determine if this combination can be safely taken. The study will look at the side effects of the Temozolomide plus Vorinostat in combination and whether the treatment schedule is tolerated.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: Merck Sharp & Dohme Corp.

Stanford Investigator(s):

Intervention(s):

  • Drug: Temozolomide

Phase:

Phase 2

Eligibility


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
   drug(s).

   - 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 period.

   - 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 requirements.

   - 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
participate.

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
drugs.

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
Jack Taw
650-723-2781