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Antifungal Therapy for Fever and Neutropenia in Patients Receiving Treatment for Hematologic Cancer
This study has been completed.
First Received: November 1, 1999   Last Updated: May 9, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 1996
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.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002742

  Show 59 Study Locations
Sponsors and Collaborators
Aronex Pharmaceuticals
Investigators
Study Chair: David S. Gordon, MD Aronex Pharmaceuticals
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010