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Status:

COMPLETED

Fluphenazine in Treating Patients With Refractory Advanced Multiple Myeloma

Lead Sponsor:

Immune Control

Conditions:

Multiple Myeloma and Plasma Cell Neoplasm

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

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 ph...

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 ...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    January 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    30 Patients enrolled

    Trial Details

    Trial ID

    NCT00335647

    Start Date

    January 1 2006

    Last Update

    November 6 2013

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    1

    Hackensack University Medical Center Cancer Center

    Hackensack, New Jersey, United States, 07601

    2

    Long Island Jewish Medical Center

    New Hyde Park, New York, United States, 11040

    3

    Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, United States, 19104-4283