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Ravuconazole in Preventing Fungal Infections in Patients Undergoing Allogeneic Stem Cell Transplantation

Breast Cancer Clinical Trial

Official title:
A Phase I-II Safety, Tolerability And Pharmacokinetic Study Of Ravuconazole For Prophylaxis Of Invasive Fungal Infections In Patients Undergoing Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trial Summary

RATIONALE: Antifungals such as ravuconazole may be effective in preventing fungal infections in patients undergoing chemotherapy and stem cell transplantation.

PURPOSE: Phase I/II trial to study the effectiveness of ravuconazole in preventing fungal infections in patients undergoing allogeneic stem cell transplantation.

Clinical Trial Description

OBJECTIVES:

- Determine the safety and tolerability of ravuconazole for the prevention of invasive fungal infections in patients undergoing non-myeloablative allogeneic hematopoietic stem cell transplantation.

- Determine the pharmacokinetics and efficacy of this drug, in terms of frequency of breakthrough fungal infections and requirement for empirical antifungal therapy, in these patients.

- Determine the effect of this drug on concurrently administered cyclosporine in these patients.

- Determine the pharmacokinetics of this drug with and without cyclosporine in these patients.

OUTLINE: This is an open-label, dose-escalation study.

Patients receive oral ravuconazole once daily beginning within 48 hours of the chemotherapy preparative regimen and before the initiation of cyclosporine. Treatment continues until blood counts recover in the absence of unacceptable toxicity.

Cohorts of 8 patients receive escalating doses of ravuconazole until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 8 patients experience dose-limiting toxicity.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study. ;

Study Design

Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

  • Breast Cancer
  • Chronic Myeloproliferative Disorders
  • Communicable Diseases
  • Gestational Trophoblastic Disease
  • Gestational Trophoblastic Tumor
  • Infection
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Mycoses
  • Myelodysplastic Syndromes
  • Myelodysplastic-Myeloproliferative Diseases
  • Myelodysplastic/Myeloproliferative Neoplasms
  • Myeloproliferative Disorders
  • Neoplasms
  • Neoplasms, Germ Cell and Embryonal
  • Neoplasms, Plasma Cell
  • Neuroblastoma
  • Ovarian Cancer
  • Plasmacytoma
  • Preleukemia
  • Testicular Germ Cell Tumor
  • Testicular Neoplasms
  • Trophoblastic Neoplasms
Clinical Trial Details
NCT number NCT00064311
Study type Interventional
Source National Institutes of Health Clinical Center (CC)
Contact
Status Completed
Phase Phase 1/Phase 2
Start date June 2003
Completion date September 2004
View Details
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