Itraconazole Compared With Fluconazole to Prevent Infections in Patients Undergoing Peripheral Stem Cell or Bone Marrow Transplantation
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| First Received Date ICMJE | November 1, 1999 | ||||
| Last Updated Date | March 31, 2010 | ||||
| Start Date ICMJE | October 1998 | ||||
| Primary Completion Date | July 2002 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00003883 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Itraconazole Compared With Fluconazole to Prevent Infections in Patients Undergoing Peripheral Stem Cell or Bone Marrow Transplantation | ||||
| Official Title ICMJE | A Randomized, Comparative Study of Itraconazole Versus Fluconazole for Prevention of Aspergillus Infections in Peripheral Blood Stem Cell and Marrow Transplant Recipients | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Primary Purpose: Supportive Care |
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| Condition ICMJE | Cancer | ||||
| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 578 | ||||
| Completion Date | July 2002 | ||||
| Primary Completion Date | July 2002 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | 13 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00003883 | ||||
| Other Study ID Numbers ICMJE | 1322.00, FHCRC-1322.00, NCI-H99-0030, CDR0000067050 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Fred Hutchinson Cancer Research Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | Fred Hutchinson Cancer Research Center | ||||
| Verification Date | March 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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