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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003938 |
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 |
Estimated Enrollment: | 450 |
Study Start Date: | June 1999 |
OBJECTIVES:
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.
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | P. Ljungman, MD | Karolinska University Hospital - Huddinge |
Study ID Numbers: | CDR0000067130, EORTC-19951 |
Study First Received: | November 1, 1999 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00003938 |
Health Authority: | United States: Federal Government |
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 |
Blast Crisis Sezary syndrome Chronic myelogenous leukemia Hodgkin lymphoma, adult Hot Flashes Lymphoma, small cleaved-cell, diffuse Seminoma Liposomal amphotericin B Small non-cleaved cell lymphoma Lymphoma, large-cell, immunoblastic Preleukemia Leukemia, Prolymphocytic Hemorrhagic thrombocythemia Lymphoma, Large-Cell, Anaplastic Neoplasm Metastasis |
Thrombocythemia, Hemorrhagic Rhabdomyosarcoma Myelodysplastic syndromes Essential thrombocytosis Amphotericin B Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myelomonocytic, Chronic Acute myelogenous leukemia Breast Neoplasms Testicular Neoplasms Leukemia, Myeloid Carcinoma Waldenstrom Macroglobulinemia Leukemia, Myeloid, Accelerated Phase Plasmacytoma |
Anti-Bacterial Agents Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents Neoplasms Neoplasms by Histologic Type |
Immune System Diseases Antifungal Agents Therapeutic Uses Antibiotics, Antifungal Amebicides Pharmacologic Actions |