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Multiple Myeloma and Plasma Cell NeoplasmPhase 1/2NCT00335647

Fluphenazine in Treating Patients With Refractory Advanced Multiple Myeloma

A Phase 1/2 study testing fluphenazine hydrochloride in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Immune Control at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
fluphenazine hydrochloride
How many people
30 participants
Where
3 sitesUnited States
Study dates
Jan 2006to Apr 2008
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Hackensack University Medical Center Cancer Center

    Hackensack, New Jersey, 07601

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-4283

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
fluphenazine hydrochloride
Keywords
stage III multiple myeloma, refractory multiple myeloma, stage II multiple myeloma
Medical subject headings
Multiple Myeloma, Neoplasms, Plasma Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fluphenazine hydrochlorideDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety

  2. Efficacy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2006 (estimated)
  2. Study startJan 2006
  3. Primary completionApr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00335647
Sponsor's protocol ID
CDR0000486281
Other IDs
IMMUNECON-FM-CL1, UPCC-IRB-5, UPCC-09405, UPCC-803972
Status last verified
Apr 2008
First submitted
8 Jun 2006
Last updated
6 Nov 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing fluphenazine hydrochloride in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Immune Control at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2013; AzTrials last refreshed its copy on 6 Nov 2026.

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