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Fluphenazine in Treating Patients With Refractory Advanced Multiple Myeloma
This study has been completed.
First Received: June 8, 2006   Last Updated: November 16, 2008   History of Changes
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safety [ Designated as safety issue: Yes ]
  • Efficacy [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2006
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00335647

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
Sponsors and Collaborators
Immune Control
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
stage III multiple myeloma
refractory multiple myeloma
stage II multiple myeloma

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 27, 2009