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Chronic Myeloproliferative DisordersPhase 3NCT00002742

Antifungal Therapy for Fever and Neutropenia in Patients Receiving Treatment for Hematologic Cancer

A Phase 3 study testing amphotericin B deoxycholate and nystatin in people with Chronic Myeloproliferative Disorders and Infection, run by Aronex Pharmaceuticals at 59 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: Antifungal therapy with liposomal nystatin may reduce fever and neutropenia in patients undergoing treatment for hematologic cancer. It is not yet known whether liposomal nystatin is more effective than standard amphotericin B in treating patients with fever and neutropenia who are receiving chemotherapy… Read more about this study

Who is it for?
Ages 2 years and older
What is being tested?
amphotericin B deoxycholate and nystatin
How many people
Not given
Where
59 sitesUnited States
Study dates
Jan 1996to Sep 2007
Phase
Phase 3
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 2 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS: Persistent febrile neutropenia associated with 1 of the following within 3 months prior to entry: Cytotoxic chemotherapy Bone marrow transplantation Neutropenia defined as either: ANC no greater than 500/mm3 ANC no greater than 1,000/mm3 and expected to decrease to 500/mm3 or less within 2 days after entry Persistent continuous or spiking fever of at least 38 C No association with administration of pyrogenic substances No response to at least 72 hours of empiric, broad-spectrum antibacterial therapy No microbiologically documented source of infection At least 30 days since documented invasive fungal infection

PATIENT CHARACTERISTICS: Age: 2 and over Performance status: Not specified Life expectancy: At least 28 days Hematopoietic: Not specified Hepatic: No grade 2 or greater hepatic impairment Renal: No grade 2 or greater renal impairment No peritoneal dialysis or hemodialysis Other: No history of severe allergic reaction to polyene antifungal agent No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile women during and for 3 months after study

PRIOR CONCURRENT THERAPY: At least 2 weeks since polyene antifungal therapy Concurrent oral prophylactic antifungal therapy with an azole antifungal agent (e.g., fluconazole, itraconazole) allowed if patient remains febrile No concurrent azole therapy At least 30 days since other investigational drug or device except investigational formulation of amphotericin B

Trial locations and contacts

59 sites in 1 country.

59 sites in 1 country

United States59 sites

  • Summa Health System

    Akron, Ohio, 44312

  • Texas Cancer Center at Brackenridge Hospital

    Austin, Texas, 78701

  • Johns Hopkins Oncology Center

    Baltimore, Maryland, 21287

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Boston University School of Medicine

    Boston, Massachusetts, 02118

  • Brooklyn Hospital Center

    Brooklyn, New York, 11201

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Rush-Presbyterian-St. Luke's Medical Center

    Chicago, Illinois, 60612

  • Office of Rosalda Rodriguez, M.D.

    Chula Vista, California, 91911

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • Cleveland Clinic Cancer Center

    Cleveland, Ohio, 44195

  • Columbia Comprehensive Cancer Care Clinic

    Columbia, Missouri, 65201

  • University of Missouri-Columbia Hospital and Clinics

    Columbia, Missouri, 65212

  • Office of Ian Baird & Mark Herbert

    Columbus, Ohio, 43215

  • University of Texas Southwestern Medical School

    Dallas, Texas, 75235-9032

  • University of Colorado Cancer Center

    Denver, Colorado, 80262

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Beckman Research Institute, City of Hope

    Duarte, California, 91010

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Holt-Krock Clinic

    Fort Smith, Arkansas, 72901-2418

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Infectious Disease Associates of Houston

    Houston, Texas, 77030

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Children's Mercy Hospital - Kansas City

    Kansas City, Missouri, 64108

  • Veterans Affairs Medical Center - Kansas City

    Kansas City, Missouri, 64128

  • Antibiotic Research Associates

    Kansas City, Missouri, 64132

  • University of Tennessee Medical Center at Knoxville

    Knoxville, Tennessee, 37920

  • Wilford Hall - 59th Medical Wing

    Lackland Air Force Base, Texas, 78236-5300

  • Lake Charles Medical and Surgical Clinic

    Lake Charles, Louisiana, 70601

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202-3591

  • Baptist Clinical Research Services

    Memphis, Tennessee, 38103

  • Sylvester Cancer Center, University of Miami

    Miami, Florida, 33136

  • Jersey Shore Cancer Center

    Neptune City, New Jersey, 07753

  • New Britain General Hospital

    New Britain, Connecticut, 06050

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • University of Oklahoma - Department of Pharmacy Practice

    Oklahoma City, Oklahoma, 73919

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-3330

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania, 19141

  • Veterans Affairs Medical Center - Phoenix (Hayden)

    Phoenix, Arizona, 85012

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15213

  • Eisenhower Medical Center

    Rancho Mirage, California, 92270

  • Riverview Medical Center

    Red Bank, New Jersey, 07701

  • United Hospital

    Saint Paul, Minnesota, 55102

  • South Texas Oncology and Hematology

    San Antonio, Texas, 78229

  • St. John's Pavilion - Springfield Clinic Research Department

    Springfield, Illinois, 62702

  • St. Vincent's Medical Center of Richmond

    Staten Island, New York, 10310

  • Infections Limited, P.S.

    Tacoma, Washington, 98405

  • Tampa Children's Hospital

    Tampa, Florida, 33677-4227

  • Scott and White Clinic

    Temple, Texas, 76508

  • Albert Einstein Comprehensive Cancer Center

    The Bronx, New York, 10461

  • Infectious Disease Associates of N.W. Ohio

    Toledo, Ohio, 43608

  • Vincent T. Lombardi Cancer Research Center, Georgetown University

    Washington D.C., District of Columbia, 20007

  • Brookview Research, Inc.

    Winston-Salem, North Carolina, 27103

  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157-1082

  • Northeast Ohio Infectious Disease Associates, Inc.

    Youngstown, Ohio, 45510

  • Medical Specialists, Inc.

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: A PROSPECTIVE RANDOMIZED, DOUBLE-BLIND, COMPARATIVE, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF NYSTATIN AND AMPHOTERICIN B FOR EMPIRIC ANTIFUNGAL TREATMENT IN NEUTROPENIC PATIENTS

RATIONALE: Antifungal therapy with liposomal nystatin may reduce fever and neutropenia in patients undergoing treatment for hematologic cancer. It is not yet known whether liposomal nystatin is more effective than standard amphotericin B in treating patients with fever and neutropenia who are receiving chemotherapy for hematologic cancer or bone marrow transplantation for leukemia.

PURPOSE: Randomized phase III trial to study the effectiveness of liposomal nystatin compared with standard amphotericin B to treat fever and neutropenia in patients receiving chemotherapy for hematologic cancer or bone marrow transplantation for leukemia.

Read the detailed description

OBJECTIVES: I. Compare the efficacy of liposomal nystatin vs standard amphotericin B for the empiric treatment of persistent febrile neutropenic patients. II. Compare the incidence of drug-related toxicity or impairment and infusion-related toxicity in patients treated with liposomal nystatin vs standard amphotericin B. III. Determine the pharmacokinetics of liposomal nystatin.

OUTLINE: Randomized, double-blind study. Arm I: Antifungal Therapy. Liposomal Nystatin. Arm II: Antifungal Therapy. Amphotericin B, NSC-527017.

PROJECTED ACCRUAL: 350 evaluable patients will be studied in this multicenter trial.

Being tested
amphotericin B deoxycholate, nystatin
Keywords
adult Hodgkin lymphoma, adult non-Hodgkin lymphoma, leukemia, childhood non-Hodgkin lymphoma, chronic myeloproliferative disorders, myelodysplastic syndromes, childhood Hodgkin lymphoma, recurrent adult non-Hodgkin lymphoma, infection, multiple myeloma and other plasma cell neoplasms, childhood myelodysplastic syndromes
Medical subject headings
Myeloproliferative Disorders, Infections, Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Hodgkin Disease

What participants receive

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

  • amphotericin B deoxycholateDrug

  • nystatinDrug

Timeline

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

  1. First posted24 Aug 2004 (estimated)
  2. Study startJan 1996
  3. Study completionSep 2007

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 3
Primary purpose
Supportive care
Allocation
Randomised
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002742
Sponsor's protocol ID
CDR0000064660
Other IDs
AR-95-41.356-006, NCI-V96-0845
Status last verified
Jul 2007
First submitted
1 Nov 1999
Last updated
26 Mar 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing amphotericin B deoxycholate and nystatin in people with Chronic Myeloproliferative Disorders and Infection, run by Aronex Pharmaceuticals at 59 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 26 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002742.

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 26 Mar 2013.

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