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Liposomal Amphotericin B in Treating Granulocytopenia and Persistent Unexplained Fever in Cancer Patients
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: November 16, 2008   History of Changes
Sponsored by: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003938
  Purpose

RATIONALE: Liposomal amphotericin B may be effective in controlling fever and granulocytopenia. It is not yet known which regimen of liposomal amphotericin B is more effective in treating cancer patients who have these conditions.

PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of liposomal amphotericin B in treating granulocytopenia and fever in cancer patients.


Condition Intervention Phase
Cancer
Drug: liposomal amphotericin B
Phase III

Study Type: Interventional
Study Design: Supportive Care, Randomized, Active Control
Official Title: A Strategic Study to Determine the Optimal Moment to Initiate Systemic Antifungal Therapy With Ambisome in Granulocytopenic Cancer Patients With Unexplained Fever Refractory to Empirical Antibacterials

Resource links provided by NLM:


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

Estimated Enrollment: 450
Study Start Date: June 1999
Detailed Description:

OBJECTIVES:

  • Compare the efficacy and side effects of amphotericin B-liposomal formulation initiated 72-84 hours vs 144-156 hours after onset of a febrile episode in cancer patients with granulocytopenia and persistent unexplained fever refractory to antibacterials.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to antifungal prophylaxis (yes vs no) and type of underlying condition. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive amphotericin B-liposomal formulation IV over 1 hour on day 3 of febrile neutropenia.
  • Arm II: Patients receive amphotericin B-liposomal formulation IV over 1 hour on day 6 of febrile neutropenia. Treatment continues until signs and symptoms of the fungal infection appear or febrile neutropenia has resolved.

Persistently neutropenic patients receive treatment for at least 10 days or until another cause of infection is determined.

Patients are followed weekly for 3 weeks.

PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Hematologic malignancy or solid tumor
  • Must be undergoing remission induction and/or consolidation therapy for hematologic malignancy only OR
  • Must be undergoing allogeneic or autologous bone marrow transplantation
  • Granulocyte count less than 500/mm^3 and profound granulocytopenia expected to last for greater than 5 days
  • Fever (greater than 38.5 degrees C) refractory for greater than 72 hours and less than 84 hours to broad spectrum antimicrobials, after exclusion of current bacterial, fungal, viral, parasitic, and mycobacterial infections
  • Peripheral blood cultures and central venous catheter cultures negative for infections
  • No microbiological documentation of a bacterial infection (e.g., abscess at catheter site)
  • No invasive fungal infection
  • No probable noninfectious cause of fever

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Karnofsky 40-100% OR
  • WHO 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No prior anaphylactic reaction to amphotericin B
  • No psychological, familial, sociological, or geographical conditions that would prevent compliance
  • Not pregnant or nursing
  • Normal chest X-ray or normal high resolution CT scan of the lungs

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No concurrent active systemic antifungal agents or antifungal prophylaxis (e.g., azoles or polyenes)
  • No prior IV amphotericin B during same neutropenic episode
  • No change in antibacterial regimen within 48 hours prior to study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003938

  Show 24 Study Locations
Sponsors and Collaborators
European Organization for Research and Treatment of Cancer
Investigators
Study Chair: P. Ljungman, MD Karolinska University Hospital - Huddinge
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067130, EORTC-19951
Study First Received: November 1, 1999
Last Updated: November 16, 2008
ClinicalTrials.gov Identifier: NCT00003938     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
stage IV breast cancer
stage IIIA breast cancer
monoclonal gammopathy of undetermined significance
stage IIIB breast cancer
recurrent childhood acute lymphoblastic leukemia
recurrent adult Hodgkin lymphoma
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
isolated plasmacytoma of bone
extramedullary plasmacytoma
refractory multiple myeloma
recurrent childhood rhabdomyosarcoma
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
disseminated neuroblastoma
recurrent neuroblastoma
recurrent Wilms tumor and other childhood kidney tumors
stage 0 chronic lymphocytic leukemia
Waldenstrom macroglobulinemia
stage I multiple myeloma
stage II multiple myeloma

Study placed in the following topic categories:
Anti-Infective Agents
Blast Crisis
Hot Flashes
Seminoma
Mantle Cell Lymphoma
Liposomal amphotericin B
Preleukemia
Leukemia, Prolymphocytic
Wilms' Tumor
Lymphoma, Large-Cell, Anaplastic
Neoplasm Metastasis
Thrombocythemia, Hemorrhagic
Rhabdomyosarcoma
Amphotericin B
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Testicular Cancer
Leukemia, Myelomonocytic, Chronic
Breast Neoplasms
Testicular Neoplasms
Leukemia, Myeloid
Carcinoma
Waldenstrom Macroglobulinemia
Leukemia, Myeloid, Accelerated Phase
Plasmacytoma
Chronic Myelogenous Leukemia
Lymphoma, Non-Hodgkin
Lymphoma, Follicular
Sezary Syndrome
Lymphoblastic Lymphoma
Neuroblastoma

Additional relevant MeSH terms:
Abelcet
Anti-Infective Agents
Amphotericin B
Antiprotozoal Agents
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Liposomal amphotericin B
Pharmacologic Actions
Anti-Bacterial Agents
Lymphatic Diseases
Antiparasitic Agents
Neoplasms
Antifungal Agents
Therapeutic Uses
Lymphoma, Large-Cell, Immunoblastic
Antibiotics, Antifungal
Amebicides
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on September 02, 2009