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Clinical Trials/NCT00744354
NCT00744354TerminatedPhase 1

A Phase 1 Dose Escalation Study of Bortezomib (Velcade®), Pegylated Liposomal Doxorubicin (Doxil®), and Vorinostat (Suberoylanilide Hydromaxic Acid, Saha, Zolinzatm) in Patients With Relapse/Refractory Multiple Myeloma

UNC Lineberger Comprehensive Cancer Center4 sites in 1 country32 target enrollmentStarted: October 2008Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Terminated
Enrollment
32
Locations
4
Primary Endpoint
Maximum tolerated dose of vorinostat

Study Overview

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

  • To determine the maximum tolerated dose of vorinostat when added to the standard regimen of bortezomib and pegylated liposomal doxorubicin hydrochloride in patients with relapsed or refractory multiple myeloma.
  • To identify the dose-limiting toxicities of this regimen in these patients.

Secondary

  • To gain preliminary evidence of antitumor activity of this regimen in these patients.
  • To assess the degree of proteasome inhibition achieved with this regimen in these patients.
  • To evaluate the accumulation of acetylated alpha-tubulin after treatment with vorinostat.
  • To evaluate overall survival, time to progression, and progression-free survival of patients treated with this regimen.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Non-Randomized Open Label Single Arm

Experimental

Phase 1 dose escalation trial of vorinostat in combination with bortezomib and pegylated liposomal doxorubicin hydrochloride.

Intervention: bortezomib (Drug)

Non-Randomized Open Label Single Arm

Experimental

Phase 1 dose escalation trial of vorinostat in combination with bortezomib and pegylated liposomal doxorubicin hydrochloride.

Intervention: pegylated liposomal doxorubicin hydrochloride (Drug)

Non-Randomized Open Label Single Arm

Experimental

Phase 1 dose escalation trial of vorinostat in combination with bortezomib and pegylated liposomal doxorubicin hydrochloride.

Intervention: vorinostat (Drug)

Outcomes

Primary Outcomes

Maximum tolerated dose of vorinostat

Time Frame: 4 years

Secondary Outcomes

  • Overall response rate(5 years)
  • Duration of response(5 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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