Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial
Official title:
A Phase I/IIa, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerance, and Preliminary Activity of Intravenous High-Dose Fluphenazine HCI in Patients With Advanced Multiple Myeloma
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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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