Clinical trial NCT00479232: Phase I Trial of Vorinostat (MK-0683, SAHA) in Combination With Decitabine in Patients With AML or MDS (MK-0683-055 EXT1)
Official title: A Phase I Clinical Trial of Vorinostat in Combination With Decitabine in Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leukemia, Myelocytic, Acute Myelodysplastic Syndromes
Myelodysplastic Syndromes
Keywords: Leukemia
Myelocytic
Acute Myelodysplastic Syndromes
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-05-28
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the safety and tolerability of vorinostat in combination with decitabine as well as the in vivo molecular and biological effects of vorinostat in patients with refractory or relapsed Acute Myelogenous Leukemia (AML) and intermediate or high risk as defined by International Prognostic Scoring System (IPSS) Myelodysplastic Syndrome (MDS). Participants with Acute Myelogenous Leukemia or Myelodysplastic Syndrome are eligible.


Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years old with refractory/relapsed AML

  * If untreated AML, patient is older than 60 years old and not a candidate for standard chemotherapy
* Patient is at least 4 weeks from prior treatment and has recovered from all prior treatment side effects
* Patient has no known liver or kidney problems
* Patient knows of no reason they can not receive transfusions of blood clotting cells (platelets)
* Patient is able to swallow capsules
* Patients both male and female are willing to practice birth control during the study

Exclusion Criteria:

* Patient has received prior treatment with valproic acid, decitabine or azacitidine
* Being is less than 18 years of age or if patient has untreated AML is below 60 years of age
* Patient is a women who is pregnant or breastfeeding. Patient has an active infection that requires antibiotics
* Patient has uncontrolled illness including but not limited to the following: heart problems (congestive heart failure, unstable angina pectoris, cardiac arrhythmia), inflammation of the pancreas; a mental or social condition that may interfere with patient following study procedures
* Patient has known human immunodeficiency virus (HIV) infection or HIV-related malignancy. Patient has a known history of hepatitis B or C infection
* Patient currently has another active cancer other than certain types of skin cancer
* Patient is heterosexual and able to have a child and is unwilling to practice birth control during the study

Primary outcomes:
measure: Number of Participants Experiencing Dose Limiting Toxicity (DLT) Events
timeFrame: Day 1 to 28 of Cycle 1
Secondary outcomes:
Other outcomes:
measure: Objective Response Rate in Participants Treated With Vorinostat + Decitabine With Refractory or Relapse Acute Myelogenous Leukemia (AML)
timeFrame: Approximately 6 months
measure: Objective Response Rate in Participants Treated With Vorinostat + Decitabine With Intermediate-high Risk Myelodysplastic Syndrome (MDS) or Untreated Acute Myelogenous Leukemia (AML)
timeFrame: Approximately 6 months
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Kirschbaum M, Gojo I, Goldberg SL, Bredeson C, Kujawski LA, Yang A, Marks P, Frankel P, Sun X, Tosolini A, Eid JE, Lubiniecki GM, Issa JP. A phase 1 clinical trial of vorinostat in combination with decitabine in patients with acute myeloid leukaemia or myelodysplastic syndrome. Br J Haematol. 2014 Oct;167(2):185-93. doi: 10.1111/bjh.13016. Epub 2014 Jul 8.