Temozolomide Plus Vorinostat in Relapse/Refractory Acute Myeloid Leukemia (AML)

Part of paid clinical trials in Stanford, California.

Sponsor
Steven E. Coutre
Study ID
NCT01550224
Phase
PHASE2
Status
Completed

Conditions

  • Acute Myeloid Leukemia With 11q23-abnormality in Relapse

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Temozolomide — DRUG
    An alkylating agent administered for induction per standard of care at 200 mg/m²/day for 7days.
  • Vorinostat — DRUG
    A synthetic hydroxamic acid derivative with antineoplastic activity administered for both groups at 500 mg orally 3 times daily for 3 days prior to Temozolomide 200 mg/m²/day.

Study Details

The purpose of the study is to first determine if temozolomide plus vorinostat in combination can control relapsed or refractory acute myeloid leukemia (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.

Key Dates

Start date
May 1, 2013
Status verified
Jul 2018
Primary completion
Nov 17, 2014
Completion
Nov 17, 2014

Study Design

Enrollment
23 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: Participant Group 1 (methylated MGMT promoter)
    Participants with methylated O6-methylguanine DNA methyltransferase (MGMT) promoter, ie, expected to have no expression of MGMT protein, will be assigned into Group 1, and will receive vorinostat 500 mg orally 3 times daily for 3 days, followed by conventional doses of temozolomide (200 mg/m2 for 7 days).
  • Active Comparator: Participant Group 2 (non-methylated MGMT promoter)
    Participants with non-methylated O6-methylguanine DNA methyltransferase (MGMT) promoter, ie, expected to have expression MGMT protein, will be assigned to into Group 2, and will initially receive daily, low doses (protracted dose schedule) of temozolomide (100 mg/m2) for 14 days in an attempt to inactivate MGMT activity. Following the protracted dose schedule, participants will receive vorinostat 500 mg orally 3 times daily for 3 days, followed by conventional doses of temozolomide (200 mg/m2 for 7 days).

Primary Outcome Measure

Complete Remission (CR) [ Time Frame: up to 10 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University Medical CenterStanfordCalifornia94305-

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Stanford University Medical Center· Stanford, CA