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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)

Hackensack University Medical Center Cancer Center

πŸ‡ΊπŸ‡Έ

Hackensack, New Jersey, United States

Long Island Jewish Medical Center

πŸ‡ΊπŸ‡Έ

New Hyde Park, New York, United States

Abramson Cancer Center of the University of Pennsylvania

πŸ‡ΊπŸ‡Έ

Philadelphia, Pennsylvania, United States

Hackensack University Medical Center Cancer Center
πŸ‡ΊπŸ‡ΈHackensack, New Jersey, United States

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