Fluphenazine in Treating Patients With Refractory Advanced Multiple Myeloma

Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00335647
• Other study ID #: CDR0000486281
• Secondary ID: IMMUNECON-FM-CL1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 8, 2006
• Last updated: November 5, 2013
• Start date: January 2006

Study information

• Verified date: April 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma

Intervention

Drug:
• fluphenazine hydrochloride

Locations

Country	Name	City	State
United States	Hackensack University Medical Center Cancer Center	Hackensack	New Jersey
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Immune Control

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety			Yes
Primary	Efficacy			No