Fluphenazine in Treating Patients With Refractory Advanced Multiple Myeloma

Sponsor

Immune Control (Industry)

Overall Status

Completed

CT.gov ID

NCT00335647

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

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.

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Jan 1, 2006

Actual Primary Completion Date :

Apr 1, 2008

Outcome Measures

Primary Outcome Measures

Safety []
Efficacy []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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