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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT00816283
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • dasatinib — DRUG
    50 mg orally 2 times per day or 140 mg orally one time per day
  • vorinostat — DRUG
    100 mg orally 2 times per day
  • cytogenetic analysis — GENETIC
    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 analysis — GENETIC
    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 analysis — GENETIC
    Performed at baseline and at every bone marrow analysis on peripheral blood
  • reverse transcriptase-polymerase chain reaction — GENETIC
    Peripheral blood drawn prior to starting Vorinostat on Day 1 and on Day 14 of treatment
  • flow cytometry — OTHER
    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 analysis — OTHER
    Performed pre-treatment and day +14 of treatment

Study Details

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.

Key Dates

Start date
Sep 30, 2008
Status verified
Jul 2012
Primary completion
Jun 30, 2011
Completion
Jun 30, 2011

Study Design

Enrollment
5 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Maximum tolerated dose [ Time Frame: 21 days after the beginning of treatment ]

Locations (2)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-3000-
City of Hope Medical GroupPasadenaCalifornia91105-

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