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Study of Fluphenazine in Relapsed or Relapsed-and-Refractory 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: NCT00821301
Recruitment Status : Unknown
Verified January 2009 by Immune Control.
Recruitment status was:  Recruiting
First Posted : January 13, 2009
Last Update Posted : January 13, 2009
Sponsor:
Information provided by:
Immune Control

Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of fluphenazine in patients with advanced multiple myeloma. The study will also describe the efficacy of this drug.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Fluphenazine HCl Phase 1

Detailed Description:

This is a multicenter, dose-escalating, Phase 1b trial in patients with relapsed or relapsed-and-refractory multiple myeloma. Patients will be dosed on Days 1 and 8 of each 21 day cycle.

This study will be conducted in two parts. In Part 1, the MTD determining portion of the study, patients will be enrolled in cohorts of 3 patients at each dose level. At least 3 patients will complete 21 days at each dose level and will be evaluated for safety and tolerability before additional patients are treated at higher doses. Doses will be increased following a modified Fibonacci scheme.

In Part 2, twelve additional patients will be enrolled at the MTD determined in Part 1 (or the dose for the highest dose cohort completed if the MTD has not been reached) to further evaluate the safety, tolerability, and preliminary efficacy of this dose regimen.

Serum fluphenazine pharmacokinetic studies will be performed during the first cycle of the therapy in all Part 1 and Part 2 consenting patients.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1b Single Arm, Open Label, Multi-Center Study of Fluphenazine HCl Monotherapy in Relapsed or Relapsed-and-Refractory Multiple Myeloma
Study Start Date : December 2008
Estimated Primary Completion Date : August 2010
Estimated Study Completion Date : October 2010



Intervention Details:
  • Drug: Fluphenazine HCl
    Fluphenazine HCl will be administered intravenously. To quickly reach and maintain the target bone marrow concentration for 18 hours, the study drug will be administered using 3 bolus injections (0, 6, and 12 hours). Fluphenazine will be dose-escalated according to a modified Fibonacci scheme, terminating in 40% increments. Treatments will be administered on days 1 and 8 of every 21 day cycle.
    Other Name: Prolixin


Primary Outcome Measures :
  1. Tolerability of fluphenazine. [ Time Frame: 21 day treatment cycle(s) ]

Secondary Outcome Measures :
  1. Changes in serum and urine M-protein or free light chain concentrations determined using protein electrophoresis. [ Time Frame: 21 day treatment cycle(s) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of multiple myeloma that is relapsed or relapsed-and-refractory after at least 2 or more prior lines of therapy. Patients must have achieved at least minor response (MR) to at least one prior line of therapy
  • Progressive disease must have occurred either during or subsequent to the patient's last treatment for multiple myeloma prior to the current enrollment
  • Measurable disease defined by serum M-protein ≥1 g/dL, or urine light chain ≥200 mg/24 hours, or abnormal serum FLC ratio with involved FLC > 10 mg/dL provided serum FLC ratio is abnormal
  • Age >18 years
  • Eastern Cooperative Oncology Group (performance status of ≤20
  • Life expectancy ≥12 weeks
  • Signed written informed consent per institutional and federal regulatory requirements
  • Did not receive chemotherapy (including systemic steroids), immunotherapy (interferon), Imids (thalidomide/lenalidomide), proteasome inhibitors (bortezomib), or radiotherapy for at least 21 days prior to Day 1 of Cycle 1
  • Did not receive any investigational treatment for at least 28 days prior to study entry
  • Absolute granulocyte count of ≥1,000/μL, platelet count ≥50,000/μL, and hemoglobin ≥8.0 g/dL, with no transfusion within the preceding 7 days
  • Adequate liver function defined by a bilirubin value ≤2 times the upper limit of normal (ULN), and transaminases (AST and ALT) values ≤2.5 times ULN
  • Adequate renal function defined by a creatinine clearance of ≥30 mL/min
  • Adequate cardiac function defined by a left ventricular ejection fraction (LVEF) ≥40%, QTc <450 msec, and no evidence of clinically significant dysrhythmias on ECG
  • Patient must have substantially recovered from clinically significant toxicities from prior therapies for multiple myeloma
  • Fertile men and women must agree to use a medically effective contraception method throughout the treatment period. Premenopausal women of reproductive capacity and women less than 24 months post menopause must have a negative serum pregnancy test documented prior to study entry

Exclusion Criteria:

  • Patients who never achieved at least minor response (MR) to at least one prior line of therapy
  • Clinical spinal cord compression syndromes (unless patient has undergone treatment, for example, surgery or radiation therapy, and neurological findings are ≤ Grade 1 and patient is off corticosteroids for spinal cord edema or on a stable regimen of < 10 mg/day prednisone equivalent
  • Clinical signs of brain involvement or leptomeningeal disease
  • Plasma cell leukemia (plasma cells > 2000/cubic mm)
  • Women who are pregnant or breast feeding
  • Other serious illness or medical condition(s) (see protocol)
  • Hypersensitivity to fluphenazine or other phenothiazines
  • Currently being treated with hematopoietic growth factors other than erythropoietin (EPO). Treatment with hematopoietic growth factors may be started during the study with development, or worsening, of cytopenia
  • Concurrent use of anticholinergics
  • Concurrent use of phenothiazine and atypical antipsychotics
  • Concurrent use of anti-seizure drugs, with the exception of gabapentin for treatment of neuropathy
  • Grade 2 or higher persisting prior treatment-related neuropathy
  • Concurrent use of systemic steroids with the exception of chronically administered steroids equivalent to ≤ 10 mg/day prednisone if patient has been on this therapy for ≥1month
  • History of seizures or extrapyramidal symptoms
  • History of other malignancies within the past 3 years, other than adequately treated non-melanoma skin cancer, or in situ carcinoma of the cervix, unless the other malignancy is quiescent and medical monitor approval is obtained

Information from the National Library of Medicine

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): NCT00821301


Contacts
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Contact: Stephen Roth, Ph.D. 610-941-2972 sroth@immunecontrol.com

Locations
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United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kristine Mykulowycz, RN    215-898-1972    kristine.mykulowycz@uphs.upenn.edu   
Contact: Ed Stadtmauer, MD    215-614-0910    edward.stadtmauer@uphs.upenn.edu   
Principal Investigator: Ed Stadtmauer, MD         
University of Pittsburgh Cancer Institute Hillman Cancer Center Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Amy O'Sullivan    412-623-4882    osullivanal@upmc.edu   
Contact: Suzanne Lentzsch, MD    412-648-6586    lentzschs@upmc.edu   
Principal Investigator: Suzanne Lentzsch, MD         
United States, Texas
Cancer Therapy and Research Center at the UT Health Sciences Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Lyanna Smith, BSN, RN    210-450-5816    smithl6@uthscsa.edu   
Contact: Swaminathan Padmanabhan, MD    210-450-5882    PadmanabhanS@uthscsa.edu   
Principal Investigator: Swaminathan Padmanabhan, MD         
Sponsors and Collaborators
Immune Control
Investigators
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Study Director: Bruce A Silver, M.D., FACP

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Responsible Party: Stephen Roth, Ph.D., Immune Control Inc.
ClinicalTrials.gov Identifier: NCT00821301     History of Changes
Other Study ID Numbers: FM-CL2
First Posted: January 13, 2009    Key Record Dates
Last Update Posted: January 13, 2009
Last Verified: January 2009
Keywords provided by Immune Control:
Multiple myeloma
Additional relevant MeSH terms:
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Hemorrhagic Disorders
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Fluphenazine
Fluphenazine depot
Fluphenazine enanthate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action