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| Sponsor: | Aronex Pharmaceuticals |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002742 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloproliferative Disorders Infection Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes |
Drug: amphotericin B deoxycholate Drug: nystatin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized |
| 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 |
| Study Start Date: | January 1996 |
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.
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Veterans Affairs Medical Center - Phoenix (Hayden) | |
| Phoenix, Arizona, United States, 85012 | |
| United States, Arkansas | |
| Arkansas Children's Hospital | |
| Little Rock, Arkansas, United States, 72202-3591 | |
| Holt-Krock Clinic | |
| Fort Smith, Arkansas, United States, 72901-2418 | |
| United States, California | |
| Beckman Research Institute, City of Hope | |
| Duarte, California, United States, 91010 | |
| Eisenhower Medical Center | |
| Rancho Mirage, California, United States, 92270 | |
| Office of Rosalda Rodriguez, M.D. | |
| Chula Vista, California, United States, 91911 | |
| United States, Colorado | |
| University of Colorado Cancer Center | |
| Denver, Colorado, United States, 80262 | |
| United States, Connecticut | |
| New Britain General Hospital | |
| New Britain, Connecticut, United States, 06050 | |
| United States, District of Columbia | |
| Vincent T. Lombardi Cancer Research Center, Georgetown University | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| Sylvester Cancer Center, University of Miami | |
| Miami, Florida, United States, 33136 | |
| Tampa Children's Hospital | |
| Tampa, Florida, United States, 33677-4227 | |
| United States, Illinois | |
| Rush-Presbyterian-St. Luke's Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| St. John's Pavilion - Springfield Clinic Research Department | |
| Springfield, Illinois, United States, 62702 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7357 | |
| United States, Louisiana | |
| Lake Charles Medical and Surgical Clinic | |
| Lake Charles, Louisiana, United States, 70601 | |
| United States, Maryland | |
| Johns Hopkins Oncology Center | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Boston University School of Medicine | |
| Boston, Massachusetts, United States, 02118 | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201 | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| United States, Minnesota | |
| United Hospital | |
| Saint Paul, Minnesota, United States, 55102 | |
| United States, Missouri | |
| Antibiotic Research Associates | |
| Kansas City, Missouri, United States, 64132 | |
| Children's Mercy Hospital - Kansas City | |
| Kansas City, Missouri, United States, 64108 | |
| Columbia Comprehensive Cancer Care Clinic | |
| Columbia, Missouri, United States, 65201 | |
| University of Missouri-Columbia Hospital and Clinics | |
| Columbia, Missouri, United States, 65212 | |
| Veterans Affairs Medical Center - Kansas City | |
| Kansas City, Missouri, United States, 64128 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-3330 | |
| United States, New Jersey | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| Jersey Shore Cancer Center | |
| Neptune, New Jersey, United States, 07753 | |
| Riverview Medical Center | |
| Red Bank, New Jersey, United States, 07701 | |
| United States, New York | |
| Albert Einstein Comprehensive Cancer Center | |
| Bronx, New York, United States, 10461 | |
| Brooklyn Hospital Center | |
| Brooklyn, New York, United States, 11201 | |
| Long Island Jewish Medical Center | |
| New Hyde Park, New York, United States, 11040 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| St. Vincent's Medical Center of Richmond | |
| Staten Island, New York, United States, 10310 | |
| United States, North Carolina | |
| Brookview Research, Inc. | |
| Winston-Salem, North Carolina, United States, 27103 | |
| Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Cleveland Clinic Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Infectious Disease Associates of N.W. Ohio | |
| Toledo, Ohio, United States, 43608 | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Office of Ian Baird & Mark Herbert | |
| Columbus, Ohio, United States, 43215 | |
| Northeast Ohio Infectious Disease Associates, Inc. | |
| Youngstown, Ohio, United States, 45510 | |
| Medical Specialists, Inc. | |
| Zanesville, Ohio, United States, 43701 | |
| Summa Health System | |
| Akron, Ohio, United States, 44312 | |
| United States, Oklahoma | |
| University of Oklahoma - Department of Pharmacy Practice | |
| Oklahoma City, Oklahoma, United States, 73919 | |
| United States, Pennsylvania | |
| Albert Einstein Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19141 | |
| University of Pennsylvania Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Tennessee | |
| Baptist Clinical Research Services | |
| Memphis, Tennessee, United States, 38103 | |
| University of Tennessee Medical Center at Knoxville | |
| Knoxville, Tennessee, United States, 37920 | |
| United States, Texas | |
| Infectious Disease Associates of Houston | |
| Houston, Texas, United States, 77030 | |
| Scott and White Clinic | |
| Temple, Texas, United States, 76508 | |
| South Texas Oncology and Hematology | |
| San Antonio, Texas, United States, 78229 | |
| Texas Cancer Center at Brackenridge Hospital | |
| Austin, Texas, United States, 78701 | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| University of Texas Southwestern Medical School | |
| Dallas, Texas, United States, 75235-9032 | |
| Wilford Hall - 59th Medical Wing | |
| Lackland Air Force Base, Texas, United States, 78236-5300 | |
| United States, Washington | |
| Infections Limited, P.S. | |
| Tacoma, Washington, United States, 98405 | |
| Study Chair: | David S. Gordon, MD | Aronex Pharmaceuticals |
More Information
| Study ID Numbers: | CDR0000064660, AR-95-41.356-006, NCI-V96-0845 |
| Study First Received: | November 1, 1999 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002742 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Abelcet Anti-Infective Agents Communicable Diseases Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Precancerous Conditions Blood Protein Disorders Nystatin Paraproteinemias Liposomal amphotericin B Infection Hemostatic Disorders Membrane Transport Modulators Anti-Bacterial Agents Leukemia |
Antiparasitic Agents Preleukemia Pathologic Processes Hemorrhagic Disorders Cholagogues and Choleretics Therapeutic Uses Antifungal Agents Syndrome Antibiotics, Antifungal Deoxycholic Acid Cardiovascular Diseases Amebicides Amphotericin B-deoxycholate Ionophores Lymphoma |