Recruiting
Phase 1

Fluphenazine

Sponsor:

Immune Control

Code:

NCT00821301

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fluphenazine HCl

Study Details

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

Study ID

NCT00821301

Start date

Dec, 2008

Status verified date

Jan, 2009

Completion date

Oct, 2010

Anticipated

Primary completion date

Aug, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Fluphenazine HCl

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.

Primary outcome measure

  • Tolerability of fluphenazine. [ Time Frame: 21 day treatment cycle(s) ]

Central Contacts and Locations

Central contacts

Stephen Roth, Ph.D.

610-941-2972sroth@immunecontrol.com

Locations

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Kristine Mykulowycz, RN

215-898-1972kristine.mykulowycz@uphs.upenn.edu

Ed Stadtmauer, MD

215-614-0910edward.stadtmauer@uphs.upenn.edu

Principal Investigator:

Ed Stadtmauer, MD

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

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Lyanna Smith, BSN, RN

210-450-5816smithl6@uthscsa.edu

Swaminathan Padmanabhan, MD

210-450-5882PadmanabhanS@uthscsa.edu

Principal Investigator:

Swaminathan Padmanabhan, MD

More Information

Sponsor

Immune Control

Last update posted

Jan 13, 2009

Last verified

Jan, 2009

Keywords

  • Multiple myeloma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Immune Control on 2009-01-13.