Spots Global Cancer Trial Database for Fluphenazine in Treating Patients With Refractory Advanced Multiple Myeloma

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Trial Identification

Brief Title: Fluphenazine in Treating Patients With Refractory Advanced Multiple Myeloma

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

Study ID: NCT00335647

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Interventions

fluphenazine hydrochloride

Study Description

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.