Clinical trial NCT00003883: Itraconazole Compared With Fluconazole to Prevent Infections in Patients Undergoing Peripheral Stem Cell or Bone Marrow Transplantation
Official title: A Randomized, Comparative Study of Itraconazole Versus Fluconazole for Prevention of Aspergillus Infections in Peripheral Blood Stem Cell and Marrow Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Keywords: stage IV breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
recurrent childhood acute lymphoblastic leukemia
recurrent adult Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
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 I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
recurrent childhood lymphoblastic lymphoma
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
stage III malignant testicular germ cell tumor
recurrent malignant testicular germ cell tumor
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
meningeal chronic myelogenous leukemia
chronic idiopathic myelofibrosis
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
refractory hairy cell leukemia
recurrent/refractory childhood Hodgkin lymphoma
recurrent ovarian germ cell tumor
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
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
secondary acute myeloid leukemia
de novo myelodysplastic syndromes
poor prognosis metastatic gestational trophoblastic tumor
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
infection
recurrent childhood small noncleaved cell lymphoma
recurrent childhood large cell 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
previously treated childhood rhabdomyosarcoma
recurrent mycosis fungoides/Sezary syndrome
noncontiguous stage II small lymphocytic lymphoma
noncontiguous stage II marginal zone lymphoma
recurrent marginal zone lymphoma
recurrent 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
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-03-31
Enrollment: 578
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

Brief summary: RATIONALE: Giving itraconazole or fluconazole may be effective in preventing infections in patients undergoing peripheral stem cell or bone marrow transplantation. It is not yet known whether itraconazole is more effective than fluconazole for preventing infections.

PURPOSE: Randomized phase III trial to compare the effectiveness of itraconazole with fluconazole to prevent infections in patients undergoing peripheral stem cell or bone marrow transplantation.

Detailed description: OBJECTIVES: I. Compare the efficacy of itraconazole versus fluconazole in reducing the incidence of breakthrough Aspergillus infections in patients undergoing allogeneic peripheral blood stem cell or bone marrow transplantation. II. Compare the incidence of combined mold/yeast infections and the use of alternative systemic antifungal treatments in these patients on this regimen. III. Compare the toxic effects of these two drugs in these patients. IV. Determine the survival rate of these patients.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I: Patients receive fluconazole orally or IV daily beginning at start of conditioning regimen and continuing until day 180 or until 4 weeks after stopping corticosteroids (if it occurs between days 120-180). Arm II: Patients receive oral fluconazole daily beginning at start of conditioning regimen and continuing until day 0. Patients then receive itraconazole orally or IV daily beginning on day 0 and continuing until day 180, or until 4 weeks after stopping corticosteroids (if it occurs between days 120-180).

PROJECTED ACCRUAL: A total of 578 patients (289 per arm) will be accrued for this study within 4 years.

Eligibility criteria: DISEASE CHARACTERISTICS: Scheduled to undergo allogeneic peripheral blood stem cell, bone marrow, or cord blood transplant (except minitransplant) No documented or suspected invasive fungal infection

PATIENT CHARACTERISTICS: Age: 13 and over Performance status: Not specified Life expectancy: More than 2 weeks Hematopoietic: Not specified Hepatic: Bilirubin no greater than 5 times upper limit of normal (ULN) OR AST or ALT no greater than 5 times ULN OR Alkaline phosphatase no greater than 5 times ULN Renal: Not specified Other: Weight at least 40 kg Fertile patients must use effective contraception No history of anaphylaxis due to azole antifungal drug compounds No uncontrolled bacteremia No concurrent condition that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No prior nonmyeloablative regimen (e.g., FHCRC-1209 or FHCRC-1225) No other concurrent antifungal agents No concurrent astemizole, terfenadine, or cisapride

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Kieren A. Marr, MD
role: STUDY_CHAIR
References: