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Fluphenazine in Treating Patients With Refractory Advanced Multiple Myeloma

Primary Purpose

Multiple Myeloma and Plasma Cell Neoplasm

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
fluphenazine hydrochloride
Sponsored by
Immune Control
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring stage III multiple myeloma, refractory multiple myeloma, stage II multiple myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hackensack University Medical Center Cancer Center
  • Long Island Jewish Medical Center
  • Abramson Cancer Center of the University of Pennsylvania

Outcomes

Primary Outcome Measures

Safety
Efficacy

Secondary Outcome Measures

Full Information

First Posted
June 8, 2006
Last Updated
November 5, 2013
Sponsor
Immune Control
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1. Study Identification

Unique Protocol Identification Number
NCT00335647
Brief Title
Fluphenazine in Treating Patients With Refractory Advanced Multiple Myeloma
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 Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Immune Control

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma and Plasma Cell Neoplasm
Keywords
stage III multiple myeloma, refractory multiple myeloma, stage II multiple myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Masking
None (Open Label)
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
fluphenazine hydrochloride
Primary Outcome Measure Information:
Title
Safety
Title
Efficacy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hackensack University Medical Center Cancer Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States

12. IPD Sharing Statement

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Fluphenazine in Treating Patients With Refractory Advanced Multiple Myeloma

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