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

Information source: Immune Control
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma

Intervention: Fluphenazine HCl (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Immune Control

Official(s) and/or principal investigator(s):
Bruce A Silver, M.D., FACP, Study Director

Overall contact:
Stephen Roth, Ph.D., Phone: 610-941-2972, Email: sroth@immunecontrol.com

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.

Clinical Details

Official title: Phase 1b Single Arm, Open Label, Multi-Center Study of Fluphenazine HCl Monotherapy in Relapsed or Relapsed-and-Refractory Multiple Myeloma

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Tolerability of fluphenazine.

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

Detailed description: This is a multicenter, dose-escalating, Phase 1b trial in patients with relapsed or relapsed-and-refractory multiple myeloma. Patients will be dosed on Days 1 and 8 of each 21 day cycle. This study will be conducted in two parts. In Part 1, the MTD determining portion of the study, patients will be enrolled in cohorts of 3 patients at each dose level. At least 3 patients will complete 21 days at each dose level and will be evaluated for safety and tolerability before additional patients are treated at higher doses. Doses will be increased following a modified Fibonacci scheme. In Part 2, twelve additional patients will be enrolled at the MTD determined in Part 1 (or the dose for the highest dose cohort completed if the MTD has not been reached) to further evaluate the safety, tolerability, and preliminary efficacy of this dose regimen. Serum fluphenazine pharmacokinetic studies will be performed during the first cycle of the therapy in all Part 1 and Part 2 consenting patients.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Stephen Roth, Ph.D., Phone: 610-941-2972, Email: sroth@immunecontrol.com

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States; Recruiting
Kristine Mykulowycz, RN, Phone: 215-898-1972, Email: kristine.mykulowycz@uphs.upenn.edu
Ed Stadtmauer, MD, Phone: 215-614-0910, Email: edward.stadtmauer@uphs.upenn.edu
Ed Stadtmauer, MD, Principal Investigator

University of Pittsburgh Cancer Institute Hillman Cancer Center, Pittsburgh, Pennsylvania 15232, United States; Not yet recruiting
Amy O'Sullivan, Phone: 412-623-4882, Email: osullivanal@upmc.edu
Suzanne Lentzsch, MD, Phone: 412-648-6586, Email: lentzschs@upmc.edu
Suzanne Lentzsch, MD, Principal Investigator

Cancer Therapy and Research Center at the UT Health Sciences Center at San Antonio, San Antonio, Texas 78229, United States; Recruiting
Lyanna Smith, BSN, RN, Phone: 210-450-5816, Email: smithl6@uthscsa.edu
Swaminathan Padmanabhan, MD, Phone: 210-450-5882, Email: PadmanabhanS@uthscsa.edu
Swaminathan Padmanabhan, MD, Principal Investigator

Additional Information

Webpage of sponsor.

Starting date: December 2008
Last updated: January 12, 2009

Page last updated: August 23, 2015

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