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Fluphenazine in Treating Patients With Refractory Advanced Multiple Myeloma

Phase 1
Completed
Conditions
Multiple Myeloma and Plasma Cell Neoplasm
Registration Number
NCT00335647
Lead Sponsor
Immune Control
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Efficacy
Safety
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (3)

Abramson Cancer Center of the University of Pennsylvania

🇺🇸

Philadelphia, Pennsylvania, United States

Long Island Jewish Medical Center

🇺🇸

New Hyde Park, New York, United States

Hackensack University Medical Center Cancer Center

🇺🇸

Hackensack, New Jersey, United States

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