Trials / Completed
CompletedNCT00335647
Fluphenazine in Treating Patients With Refractory Advanced Multiple Myeloma
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Immune Control · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | fluphenazine hydrochloride |
Timeline
- Start date
- 2006-01-01
- Primary completion
- 2008-04-01
- First posted
- 2006-06-12
- Last updated
- 2013-11-06
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00335647. Inclusion in this directory is not an endorsement.