Vorinostat, Bortezomib, and Doxorubicin Hydrochloride Liposome in Treating Patients With Relapsed or Refractory Multiple Myeloma

Part of paid clinical trials in New York, New York.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT00744354
Phase
PHASE1
Status
Terminated

Conditions

  • Multiple Myeloma and Plasma Cell Neoplasm

Eligibility Criteria

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

Interventions

  • bortezomib — DRUG
    Intravenous Push 1.3 mg/m2 Days 1, 4, 8, and 11
  • pegylated liposomal doxorubicin hydrochloride — DRUG
    Intravenous infusion, 30mg/m2, Day 4, each cycle
  • vorinostat — DRUG
    Oral, 300mg, Days 1, 2, 4, 5, 8, 9, 11, 12, every cycle.

Study Details

RATIONALE: Vorinostat and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of multiple myeloma by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving doxorubicin hydrochloride liposome together with vorinostat and bortezomib may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat and to see how well it works when given together with bortezomib and doxorubicin hydrochloride liposome in treating patients with relapsed or refractory multiple myeloma.

Key Dates

Start date
Oct 31, 2008
Status verified
Jan 2018
Primary completion
Dec 31, 2011
Completion
Apr 30, 2015

Study Design

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

Arms

  • Experimental: Non-Randomized Open Label Single Arm
    Phase 1 dose escalation trial of vorinostat in combination with bortezomib and pegylated liposomal doxorubicin hydrochloride.

Primary Outcome Measure

Maximum tolerated dose of vorinostat [ Time Frame: 4 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
Mount Sinai Medical CenterNew YorkNew York10029-
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel HillNorth Carolina27599-7295-
Duke Comprehensive Cancer CenterDurhamNorth Carolina27710-
Wake Forest University Comprehensive Cancer CenterWinston-SalemNorth Carolina27157-1096-

Find similar trials in New York, NY

By research site
Mount Sinai Medical Center· New York, NYLineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill· Chapel Hill, NCDuke Comprehensive Cancer Center· Durham, NCWake Forest University Comprehensive Cancer Center· Winston-Salem, NC

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