Fluphenazine in Treating Patients With Refractory Advanced Multiple Myeloma

NCT00335647 | Completed Phase 1

• 5 other identifiers: CDR0000486281IMMUNECON-FM-CL1UPCC-IRB-5UPCC-09405UPCC-803972
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage III multiple myeloma; refractory multiple myeloma; stage II multiple myeloma

Outcome Measures

Primary Outcomes (2)

• Safety

• Efficacy

Interventions

fluphenazine hydrochloride DRUG

Eligibility Criteria

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Immune Control: lead

Study Sites (3)

Hackensack University Medical Center Cancer Center

Hackensack, New Jersey, 07601, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Fluphenazine

Condition Hierarchy (Ancestors)

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 Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 8, 2006
• First Posted: June 12, 2006
• Study Start: January 1, 2006
• Primary Completion: April 1, 2008
• Last Updated: November 6, 2013

Record last verified: 2008-04

Locations

US (3)