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| Sponsor: | Immune Control |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00335647 |
Purpose
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 |
| 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.
Eligibility| 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
Contacts and Locations| 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 | |
More Information
| Study ID Numbers: | CDR0000486281, IMMUNECON-FM-CL1, UPCC-IRB-5, UPCC-09405, UPCC-803972 |
| Study First Received: | June 8, 2006 |
| Last Updated: | November 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00335647 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
stage III multiple myeloma refractory multiple myeloma stage II multiple myeloma |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Blood Protein Disorders Physiological Effects of Drugs Psychotropic Drugs Paraproteinemias Hemostatic Disorders Hemorrhagic Disorders Therapeutic Uses Fluphenazine depot Cardiovascular Diseases Fluphenazine Immunoproliferative Disorders Neoplasms by Histologic Type |
Tranquilizing Agents Immune System Diseases Hematologic Diseases Vascular Diseases Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents Pharmacologic Actions Multiple Myeloma Neoplasms Dopamine Agents Lymphoproliferative Disorders Central Nervous System Agents Neoplasms, Plasma Cell |