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

NCT00002742 | Completed Phase 3

• 3 other identifiers: CDR0000064660AR-95-41.356-006NCI-V96-0845
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 59

Brief 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 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.

Conditions

Chronic Myeloproliferative Disorders; Infection; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes

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

Interventions

amphotericin B deoxycholate DRUG

nystatin DRUG

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Aronex Pharmaceuticals: lead

Study Sites (59)

Veterans Affairs Medical Center - Phoenix (Hayden)

Phoenix, Arizona, 85012, United States

Location

Holt-Krock Clinic

Fort Smith, Arkansas, 72901-2418, United States

Location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591, United States

Location

Office of Rosalda Rodriguez, M.D.

Chula Vista, California, 91911, United States

Location

Beckman Research Institute, City of Hope

Duarte, California, 91010, United States

Location

Eisenhower Medical Center

Rancho Mirage, California, 92270, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80262, United States

Location

New Britain General Hospital

New Britain, Connecticut, 06050, United States

Location

Vincent T. Lombardi Cancer Research Center, Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Sylvester Cancer Center, University of Miami

Miami, Florida, 33136, United States

Location

Tampa Children's Hospital

Tampa, Florida, 33677-4227, United States

Location

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

St. John's Pavilion - Springfield Clinic Research Department

Springfield, Illinois, 62702, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

Lake Charles Medical and Surgical Clinic

Lake Charles, Louisiana, 70601, United States

Location

Johns Hopkins Oncology Center

Baltimore, Maryland, 21287, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

Columbia Comprehensive Cancer Care Clinic

Columbia, Missouri, 65201, United States

Location

University of Missouri-Columbia Hospital and Clinics

Columbia, Missouri, 65212, United States

Location

Children's Mercy Hospital - Kansas City

Kansas City, Missouri, 64108, United States

Location

Veterans Affairs Medical Center - Kansas City

Kansas City, Missouri, 64128, United States

Location

Antibiotic Research Associates

Kansas City, Missouri, 64132, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-3330, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Jersey Shore Cancer Center

Neptune City, New Jersey, 07753, United States

Location

Riverview Medical Center

Red Bank, New Jersey, 07701, United States

Location

Brooklyn Hospital Center

Brooklyn, New York, 11201, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

St. Vincent's Medical Center of Richmond

Staten Island, New York, 10310, United States

Location

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, 10461, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Brookview Research, Inc.

Winston-Salem, North Carolina, 27103, United States

Location

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157-1082, United States

Location

Summa Health System

Akron, Ohio, 44312, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Cleveland Clinic Cancer Center

Cleveland, Ohio, 44195, United States

Location

Office of Ian Baird & Mark Herbert

Columbus, Ohio, 43215, United States

Location

Infectious Disease Associates of N.W. Ohio

Toledo, Ohio, 43608, United States

Location

Northeast Ohio Infectious Disease Associates, Inc.

Youngstown, Ohio, 45510, United States

Location

Medical Specialists, Inc.

Zanesville, Ohio, 43701, United States

Location

University of Oklahoma - Department of Pharmacy Practice

Oklahoma City, Oklahoma, 73919, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Albert Einstein Cancer Center

Philadelphia, Pennsylvania, 19141, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Tennessee Medical Center at Knoxville

Knoxville, Tennessee, 37920, United States

Location

Baptist Clinical Research Services

Memphis, Tennessee, 38103, United States

Location

Texas Cancer Center at Brackenridge Hospital

Austin, Texas, 78701, United States

Location

University of Texas Southwestern Medical School

Dallas, Texas, 75235-9032, United States

Location

Infectious Disease Associates of Houston

Houston, Texas, 77030, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Wilford Hall - 59th Medical Wing

Lackland Air Force Base, Texas, 78236-5300, United States

Location

South Texas Oncology and Hematology

San Antonio, Texas, 78229, United States

Location

Scott and White Clinic

Temple, Texas, 76508, United States

Location

Infections Limited, P.S.

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Myeloproliferative Disorders; Infections; Leukemia; Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Myelodysplastic Syndromes; Hodgkin Disease; Lymphoma, Non-Hodgkin

Interventions

amphotericin B, deoxycholate drug combination; Nystatin

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• David S. Gordon, MD

  Aronex Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: August 24, 2004
• Study Start: January 1, 1996
• Study Completion: September 1, 2007
• Last Updated: March 26, 2013

Record last verified: 2007-07

Locations

US (59)