Study of Fluphenazine in Relapsed or Relapsed-and-Refractory Multiple Myeloma

NCT00821301 | Unknown Phase 1 DMC

• 1 other identifier: FM-CL2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of fluphenazine in patients with advanced multiple myeloma. The study will also describe the efficacy of this drug.

Conditions

Multiple Myeloma

Keywords

Multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Tolerability of fluphenazine.

  21 day treatment cycle(s)

Secondary Outcomes (1)

• Changes in serum and urine M-protein or free light chain concentrations determined using protein electrophoresis.

  21 day treatment cycle(s)

Interventions

Fluphenazine HCl DRUG

Fluphenazine HCl will be administered intravenously. To quickly reach and maintain the target bone marrow concentration for 18 hours, the study drug will be administered using 3 bolus injections (0, 6, and 12 hours). Fluphenazine will be dose-escalated according to a modified Fibonacci scheme, terminating in 40% increments. Treatments will be administered on days 1 and 8 of every 21 day cycle.

Also known as: Prolixin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed diagnosis of multiple myeloma that is relapsed or relapsed-and-refractory after at least 2 or more prior lines of therapy. Patients must have achieved at least minor response (MR) to at least one prior line of therapy
• Progressive disease must have occurred either during or subsequent to the patient's last treatment for multiple myeloma prior to the current enrollment
• Measurable disease defined by serum M-protein ≥1 g/dL, or urine light chain ≥200 mg/24 hours, or abnormal serum FLC ratio with involved FLC \> 10 mg/dL provided serum FLC ratio is abnormal
• Age \>18 years
• Eastern Cooperative Oncology Group (performance status of ≤20
• Life expectancy ≥12 weeks
• Signed written informed consent per institutional and federal regulatory requirements
• Did not receive chemotherapy (including systemic steroids), immunotherapy (interferon), Imids (thalidomide/lenalidomide), proteasome inhibitors (bortezomib), or radiotherapy for at least 21 days prior to Day 1 of Cycle 1
• Did not receive any investigational treatment for at least 28 days prior to study entry
• Absolute granulocyte count of ≥1,000/μL, platelet count ≥50,000/μL, and hemoglobin ≥8.0 g/dL, with no transfusion within the preceding 7 days
• Adequate liver function defined by a bilirubin value ≤2 times the upper limit of normal (ULN), and transaminases (AST and ALT) values ≤2.5 times ULN
• Adequate renal function defined by a creatinine clearance of ≥30 mL/min
• Adequate cardiac function defined by a left ventricular ejection fraction (LVEF) ≥40%, QTc \<450 msec, and no evidence of clinically significant dysrhythmias on ECG
• Patient must have substantially recovered from clinically significant toxicities from prior therapies for multiple myeloma
• Fertile men and women must agree to use a medically effective contraception method throughout the treatment period. Premenopausal women of reproductive capacity and women less than 24 months post menopause must have a negative serum pregnancy test documented prior to study entry

You may not qualify if:

• Patients who never achieved at least minor response (MR) to at least one prior line of therapy
• Clinical spinal cord compression syndromes (unless patient has undergone treatment, for example, surgery or radiation therapy, and neurological findings are ≤ Grade 1 and patient is off corticosteroids for spinal cord edema or on a stable regimen of \< 10 mg/day prednisone equivalent
• Clinical signs of brain involvement or leptomeningeal disease
• Plasma cell leukemia (plasma cells \> 2000/cubic mm)
• Women who are pregnant or breast feeding
• Other serious illness or medical condition(s) (see protocol)
• Hypersensitivity to fluphenazine or other phenothiazines
• Currently being treated with hematopoietic growth factors other than erythropoietin (EPO). Treatment with hematopoietic growth factors may be started during the study with development, or worsening, of cytopenia
• Concurrent use of anticholinergics
• Concurrent use of phenothiazine and atypical antipsychotics
• Concurrent use of anti-seizure drugs, with the exception of gabapentin for treatment of neuropathy
• Grade 2 or higher persisting prior treatment-related neuropathy
• Concurrent use of systemic steroids with the exception of chronically administered steroids equivalent to ≤ 10 mg/day prednisone if patient has been on this therapy for ≥1month
• History of seizures or extrapyramidal symptoms
• History of other malignancies within the past 3 years, other than adequately treated non-melanoma skin cancer, or in situ carcinoma of the cervix, unless the other malignancy is quiescent and medical monitor approval is obtained

Sponsors & Collaborators

• Immune Control: lead

Study Sites (3)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Pittsburgh Cancer Institute Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

NOT YET RECRUITING

Cancer Therapy and Research Center at the UT Health Sciences Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Fluphenazine

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bruce A Silver, M.D., FACP

  STUDY DIRECTOR

Central Study Contacts

Stephen Roth, Ph.D.

CONTACT

610-941-2972; sroth@immunecontrol.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 9, 2009
• First Posted: January 13, 2009
• Study Start: December 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: October 1, 2010
• Last Updated: January 13, 2009

Record last verified: 2009-01

Locations

US (3)