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Fluphenazine in Treating Patients With Refractory Advanced Multiple Myeloma

NCT ID: NCT00335647

Last Updated: 2013-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Brief Summary

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RATIONALE: Drugs used in chemotherapy, such as fluphenazine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase I/II trial is studying the side effects and best dose of fluphenazine and to see how well it works in treating patients with refractory advanced multiple myeloma.

Detailed Description

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OBJECTIVES:

* Determine the safety of high-dose fluphenazine hydrochloride in patients with refractory advanced multiple myeloma.
* Determine the pharmacological properties of this drug.
* Determine the effectiveness of this drug in these patients.

OUTLINE: This is an open-label, dose-escalation study.

Patients receive high-dose fluphenazine hydrochloride IV 3 times on day 1. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of patients receive escalating doses of fluphenazine hydrochloride until the maximum tolerated dose is determined.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Conditions

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Multiple Myeloma and Plasma Cell Neoplasm

Keywords

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stage III multiple myeloma refractory multiple myeloma stage II multiple myeloma

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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fluphenazine hydrochloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* At least 28 days since prior investigational agents
* At least 6 weeks since prior selective serotonin reuptake inhibitors (SSRIs) (a wash-out period equivalent to 5 times the terminal elimination half-life is required for tricyclic antidepressants or norepinephrine reuptake inhibitors)
* No concurrent SSRIs, tricyclic antidepressants, or norepinephrine reuptake inhibitors
* No concurrent dialysis therapy
* No concurrent hematopoietic growth factors except epoetin alfa

* Treatment with hematopoietic growth factors may be started during study if patient develops or has progressive cytopenia
* No concurrent anticholinergics or other antipsychotics
* No concurrent antiseizure drugs except Neurontin for treatment of neuropathy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Immune Control

INDUSTRY

Sponsor Role lead

Locations

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Hackensack University Medical Center Cancer Center

Hackensack, New Jersey, United States

Site Status

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Site Status

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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IMMUNECON-FM-CL1

Identifier Type: -

Identifier Source: secondary_id

UPCC-IRB-5

Identifier Type: -

Identifier Source: secondary_id

UPCC-09405

Identifier Type: -

Identifier Source: secondary_id

UPCC-803972

Identifier Type: -

Identifier Source: secondary_id

CDR0000486281

Identifier Type: -

Identifier Source: org_study_id