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
Phase 3
N/A
N/A
N/A
N/A
Not Enrolling
Both
Cancer
Both
Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Supportive Care
Principal Investigator
P. Ljungman, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Karolinska Institutet
Authority:
United States: Federal Government
Study ID:
EORTC-19951
NCT ID:
NCT00003938
Start Date:
June 1999
Completion Date:
Related Keywords:
- Cancer
- 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
- stage III multiple myeloma
- stage I childhood lymphoblastic lymphoma
- stage II childhood lymphoblastic lymphoma
- stage III childhood lymphoblastic lymphoma
- stage IV childhood lymphoblastic lymphoma
- recurrent childhood lymphoblastic lymphoma
- stage I chronic lymphocytic leukemia
- stage II chronic lymphocytic leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- recurrent childhood acute myeloid leukemia
- recurrent adult acute myeloid leukemia
- recurrent adult acute lymphoblastic leukemia
- relapsing chronic myelogenous leukemia
- refractory chronic lymphocytic leukemia
- small intestine lymphoma
- stage III malignant testicular germ cell tumor
- recurrent malignant testicular germ cell tumor
- unspecified childhood solid tumor, protocol specific
- unspecified adult solid tumor, protocol specific
- chronic phase chronic myelogenous leukemia
- accelerated phase chronic myelogenous leukemia
- blastic phase chronic myelogenous leukemia
- meningeal chronic myelogenous leukemia
- adult acute myeloid leukemia in remission
- adult acute lymphoblastic leukemia in remission
- childhood acute myeloid leukemia in remission
- childhood acute lymphoblastic leukemia in remission
- polycythemia vera
- primary myelofibrosis
- essential thrombocythemia
- fever, sweats, and hot flashes
- childhood acute promyelocytic leukemia (M3)
- testicular embryonal carcinoma
- testicular choriocarcinoma
- testicular teratoma
- testicular yolk sac tumor
- testicular embryonal carcinoma and teratoma
- testicular embryonal carcinoma and teratoma with seminoma
- testicular embryonal carcinoma and yolk sac tumor
- testicular embryonal carcinoma and yolk sac tumor with seminoma
- testicular embryonal carcinoma and seminoma
- testicular yolk sac tumor and teratoma
- testicular yolk sac tumor and teratoma with seminoma
- testicular choriocarcinoma and yolk sac tumor
- testicular choriocarcinoma and embryonal carcinoma
- testicular choriocarcinoma and teratoma
- testicular choriocarcinoma and seminoma
- progressive hairy cell leukemia, initial treatment
- refractory hairy cell leukemia
- stage II childhood Hodgkin lymphoma
- stage I childhood Hodgkin lymphoma
- stage III childhood Hodgkin lymphoma
- stage IV childhood Hodgkin lymphoma
- recurrent/refractory childhood Hodgkin lymphoma
- stage I grade 1 follicular lymphoma
- stage I grade 2 follicular lymphoma
- stage I grade 3 follicular lymphoma
- stage I adult diffuse small cleaved cell lymphoma
- stage I adult diffuse mixed cell lymphoma
- stage I adult diffuse large cell lymphoma
- stage I adult immunoblastic large cell lymphoma
- stage I adult lymphoblastic lymphoma
- stage I adult Burkitt lymphoma
- recurrent ovarian germ cell tumor
- chronic myelomonocytic leukemia
- T-cell large granular lymphocyte leukemia
- ovarian yolk sac tumor
- ovarian embryonal carcinoma
- ovarian polyembryoma
- ovarian choriocarcinoma
- ovarian immature teratoma
- ovarian mature teratoma
- ovarian monodermal and highly specialized teratoma
- ovarian mixed germ cell tumor
- acute undifferentiated leukemia
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult lymphoblastic lymphoma
- stage III adult Burkitt lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV adult Burkitt lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent adult Burkitt lymphoma
- stage I adult T-cell leukemia/lymphoma
- stage II adult T-cell leukemia/lymphoma
- stage III adult T-cell leukemia/lymphoma
- stage IV adult T-cell leukemia/lymphoma
- recurrent adult T-cell leukemia/lymphoma
- de novo myelodysplastic syndromes
- high risk metastatic gestational trophoblastic tumor
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- primary central nervous system non-Hodgkin lymphoma
- neutropenia
- infection
- previously untreated childhood rhabdomyosarcoma
- prolymphocytic leukemia
- primary systemic amyloidosis
- intraocular lymphoma
- stage I childhood small noncleaved cell lymphoma
- stage I childhood large cell lymphoma
- stage II childhood small noncleaved cell lymphoma
- stage II childhood large cell lymphoma
- stage III childhood small noncleaved cell lymphoma
- stage III childhood large cell lymphoma
- stage IV childhood small noncleaved cell lymphoma
- stage IV childhood large cell lymphoma
- recurrent childhood small noncleaved cell lymphoma
- recurrent childhood large cell lymphoma
- stage I mantle cell lymphoma
- contiguous stage II grade 1 follicular lymphoma
- contiguous stage II grade 2 follicular lymphoma
- contiguous stage II grade 3 follicular lymphoma
- contiguous stage II adult diffuse small cleaved cell lymphoma
- contiguous stage II mantle cell lymphoma
- contiguous stage II adult diffuse mixed cell lymphoma
- contiguous stage II adult immunoblastic large cell lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- contiguous stage II adult Burkitt lymphoma
- contiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- noncontiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II mantle cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- recurrent mantle cell lymphoma
- angioimmunoblastic T-cell lymphoma
- anaplastic large cell lymphoma
- previously treated childhood rhabdomyosarcoma
- stage I mycosis fungoides/Sezary syndrome
- stage II mycosis fungoides/Sezary syndrome
- stage III mycosis fungoides/Sezary syndrome
- stage IV mycosis fungoides/Sezary syndrome
- recurrent mycosis fungoides/Sezary syndrome
- childhood chronic myelogenous leukemia
- chronic eosinophilic leukemia
- chronic neutrophilic leukemia
- contiguous stage II marginal zone lymphoma
- contiguous stage II small lymphocytic lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- noncontiguous stage II marginal zone lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage I marginal zone lymphoma
- stage I small lymphocytic lymphoma
- stage III small lymphocytic lymphoma
- stage III marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- childhood myelodysplastic syndromes
- Agranulocytosis
- Lymphoma, Non-Hodgkin
- Lymphoma, Large-Cell, Immunoblastic
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