Lymphoma Clinical Trial
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
| Verified date | July 2007 |
| Source | National Cancer Institute (NCI) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Federal Government |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | September 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 2 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| United States | Summa Health System | Akron | Ohio |
| United States | Texas Cancer Center at Brackenridge Hospital | Austin | Texas |
| United States | Johns Hopkins Oncology Center | Baltimore | Maryland |
| United States | Boston University School of Medicine | Boston | Massachusetts |
| United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
| United States | Albert Einstein Comprehensive Cancer Center | Bronx | New York |
| United States | Brooklyn Hospital Center | Brooklyn | New York |
| United States | Roswell Park Cancer Institute | Buffalo | New York |
| United States | Rush-Presbyterian-St. Luke's Medical Center | Chicago | Illinois |
| United States | Office of Rosalda Rodriguez, M.D. | Chula Vista | California |
| United States | Cleveland Clinic Cancer Center | Cleveland | Ohio |
| United States | Ireland Cancer Center | Cleveland | Ohio |
| United States | Columbia Comprehensive Cancer Care Clinic | Columbia | Missouri |
| United States | University of Missouri-Columbia Hospital and Clinics | Columbia | Missouri |
| United States | Office of Ian Baird & Mark Herbert | Columbus | Ohio |
| United States | University of Texas Southwestern Medical School | Dallas | Texas |
| United States | University of Colorado Cancer Center | Denver | Colorado |
| United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
| United States | Henry Ford Hospital | Detroit | Michigan |
| United States | Beckman Research Institute, City of Hope | Duarte | California |
| United States | Duke Comprehensive Cancer Center | Durham | North Carolina |
| United States | Holt-Krock Clinic | Fort Smith | Arkansas |
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| United States | Infectious Disease Associates of Houston | Houston | Texas |
| United States | University of Texas - MD Anderson Cancer Center | Houston | Texas |
| United States | Antibiotic Research Associates | Kansas City | Missouri |
| United States | Children's Mercy Hospital - Kansas City | Kansas City | Missouri |
| United States | University of Kansas Medical Center | Kansas City | Kansas |
| United States | Veterans Affairs Medical Center - Kansas City | Kansas City | Missouri |
| United States | University of Tennessee Medical Center at Knoxville | Knoxville | Tennessee |
| United States | Wilford Hall - 59th Medical Wing | Lackland Air Force Base | Texas |
| United States | Lake Charles Medical and Surgical Clinic | Lake Charles | Louisiana |
| United States | Arkansas Children's Hospital | Little Rock | Arkansas |
| United States | Baptist Clinical Research Services | Memphis | Tennessee |
| United States | Sylvester Cancer Center, University of Miami | Miami | Florida |
| United States | Jersey Shore Cancer Center | Neptune | New Jersey |
| United States | New Britain General Hospital | New Britain | Connecticut |
| United States | Long Island Jewish Medical Center | New Hyde Park | New York |
| United States | University of Oklahoma - Department of Pharmacy Practice | Oklahoma City | Oklahoma |
| United States | University of Nebraska Medical Center | Omaha | Nebraska |
| United States | Albert Einstein Cancer Center | Philadelphia | Pennsylvania |
| United States | University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania |
| United States | Veterans Affairs Medical Center - Phoenix (Hayden) | Phoenix | Arizona |
| United States | University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania |
| United States | Eisenhower Medical Center | Rancho Mirage | California |
| United States | Riverview Medical Center | Red Bank | New Jersey |
| United States | United Hospital | Saint Paul | Minnesota |
| United States | South Texas Oncology and Hematology | San Antonio | Texas |
| United States | St. John's Pavilion - Springfield Clinic Research Department | Springfield | Illinois |
| United States | St. Vincent's Medical Center of Richmond | Staten Island | New York |
| United States | Infections Limited, P.S. | Tacoma | Washington |
| United States | Tampa Children's Hospital | Tampa | Florida |
| United States | Scott and White Clinic | Temple | Texas |
| United States | Infectious Disease Associates of N.W. Ohio | Toledo | Ohio |
| United States | Vincent T. Lombardi Cancer Research Center, Georgetown University | Washington | District of Columbia |
| United States | Brookview Research, Inc. | Winston-Salem | North Carolina |
| United States | Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina |
| United States | Northeast Ohio Infectious Disease Associates, Inc. | Youngstown | Ohio |
| United States | Medical Specialists, Inc. | Zanesville | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Aronex Pharmaceuticals |
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