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Sponsored by: |
Immune Control |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00335647 |
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 | Intervention | Phase |
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: fluphenazine hydrochloride |
Phase I Phase II |
Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
MedlinePlus related topics: | Cancer Multiple Myeloma |
ChemIDplus related topics: | Fluphenazine Fluphenazine depot Fluphenazine enanthate Fluphenazine hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, 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 |
Estimated Enrollment: | 30 |
Study Start Date: | January 2006 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed multiple myeloma
No spinal cord compression unless the following criteria are met:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
At least 21 days since prior and no concurrent systemic steroids
No concurrent hematopoietic growth factors except epoetin alfa
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 |
Immune Control |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000486281, IMMUNECON-FM-CL1, UPCC-IRB-5, UPCC-09405, UPCC-803972 |
First Received: | June 8, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00335647 |
Health Authority: | United States: Food and Drug Administration |
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