Fluphenazine in Treating Patients With Refractory Advanced Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00335647|
Recruitment Status : Completed
First Posted : June 12, 2006
Last Update Posted : November 6, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm||Drug: fluphenazine hydrochloride||Phase 1 Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Masking:||None (Open Label)|
|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 Start Date :||January 2006|
|Actual Primary Completion Date :||April 2008|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335647
|United States, New Jersey|
|Hackensack University Medical Center Cancer Center|
|Hackensack, New Jersey, United States, 07601|
|United States, New York|
|Long Island Jewish Medical Center|
|New Hyde Park, New York, United States, 11040|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|