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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
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Brief 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.


Condition or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Drug: fluphenazine hydrochloride Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Masking: None (Open Label)
Primary Purpose: Treatment
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





Primary Outcome Measures :
  1. Safety
  2. Efficacy


Information from the National Library of Medicine

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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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed multiple myeloma

    • Advanced disease
    • Must be refractory to ≥ 2 different methods of standard treatment
  • Measurable disease, defined as serum paraprotein ≥ 1g/L or urine light chain ≥ 200 mg/24 hours
  • No brain involvement or leptomeningeal disease
  • No spinal cord compression unless the following criteria are met:

    • Patient has undergone prior surgery or radiotherapy
    • Neurological findings are ≤ grade 1
    • Patient is off steroids for spinal cord edema or is on a stable regimen of ≤ 10 mg/day of prednisone or equivalent

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 (ECOG PS 3 allowed if related to skeletal lesions)
  • Life expectancy ≥ 12 weeks
  • Absolute granulocyte count ≥ 1,000/mm^3*
  • Platelet count ≥ 50,000/mm^3*
  • Hemoglobin ≥ 8.0 g/dL* (no transfusion within the past 7 days)
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 2 times ULN
  • Creatinine clearance ≥ 30 mL/min
  • LVEF ≥ 40%
  • QTc < 450 msec
  • No evidence of dysrhythmias on EKG
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No congestive heart failure
  • No angina pectoris
  • No cardiac arrhythmia
  • No uncontrolled hypertension, defined as systolic blood pressure (BP) > 180 mm Hg and/or diastolic BP > 105 mm Hg
  • No myocardial infarction within the past year
  • No active infection
  • No HIV, hepatitis B, or hepatitis C infection
  • No history of psychosis
  • No history of subcortical brain damage
  • No hypersensitivity to fluphenazine hydrochloride or other phenothiazines
  • No history of seizures or extrapyramidal symptoms
  • No other serious illness or medical condition
  • No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix NOTE: *Patients with values outside of this range due to infiltration by myeloma may be allowed at the discretion of the investigator

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior therapy
  • At least 21 days since prior chemotherapy, immunotherapy, or radiotherapy
  • At least 21 days since prior and no concurrent systemic steroids

    • Patients who have been taking chronically administered steroids for ≥ 1 month at a dose ≤ 10 mg/day of prednisone or equivalent are eligible
  • At least 28 days since prior investigational agents
  • At least 6 weeks since prior selective serotonin reuptake inhibitors (SSRIs) (a wash-out period equivalent to 5 times the terminal elimination half-life is required for tricyclic antidepressants or norepinephrine reuptake inhibitors)
  • No concurrent SSRIs, tricyclic antidepressants, or norepinephrine reuptake inhibitors
  • No concurrent dialysis therapy
  • No concurrent hematopoietic growth factors except epoetin alfa

    • Treatment with hematopoietic growth factors may be started during study if patient develops or has progressive cytopenia
  • No concurrent anticholinergics or other antipsychotics
  • No concurrent antiseizure drugs except Neurontin for treatment of neuropathy

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): NCT00335647


Locations
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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
Sponsors and Collaborators
Immune Control

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ClinicalTrials.gov Identifier: NCT00335647     History of Changes
Other Study ID Numbers: CDR0000486281
IMMUNECON-FM-CL1
UPCC-IRB-5
UPCC-09405
UPCC-803972
First Posted: June 12, 2006    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: April 2008
Keywords provided by National Cancer Institute (NCI):
stage III multiple myeloma
refractory multiple myeloma
stage II multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
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