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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00064311
Recruitment Status : Completed
First Posted : July 9, 2003
Last Update Posted : March 8, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Breast Cancer Chronic Myeloproliferative Disorders Gestational Trophoblastic Tumor Infection Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Neuroblastoma Ovarian Cancer Testicular Germ Cell Tumor Drug: ravuconazole Phase 1 Phase 2

Detailed 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
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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Study Start Date : June 2003
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Multiple Myeloma Ovarian Cancer Ovarian Epithelial Cancer Lymphosarcoma Mantle Cell Lymphoma Myelodysplastic Syndromes Primary Myelofibrosis Chronic Myeloproliferative Disorders Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Chronic Lymphocytic Leukemia B-cell Lymphoma Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Cutaneous T-cell Lymphoma Follicular Lymphoma Chronic Myeloid Leukemia Neuroblastoma Diffuse Large B-Cell Lymphoma Hodgkin Lymphoma Hairy Cell Leukemia Marginal Zone Lymphoma Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Plasmacytoma Myelodysplastic/myeloproliferative Disease Gestational Trophoblastic Tumor Burkitt Lymphoma Ovarian Germ Cell Tumor Neuroepithelioma

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Undergoing a non-myeloablative allogeneic hematopoietic stem cell transplantation
  • Must be able to start prophylactic antifungal therapy within 48 hours of the transplantation chemotherapy preparative regimen and before the initiation of cyclosporine
  • No diagnosis of deeply invasive fungal infection based on the MSG/EORTC criteria

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Bilirubin no greater than 5 times upper limit of normal (ULN)
  • AST and ALT no greater than 5 times ULN
  • Alkaline phosphatase no greater than 5 times ULN

Renal

  • Not specified

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 4 weeks (12 weeks for males) after study participation
  • Able to swallow oral medication
  • Sufficient venous access
  • No prior anaphylaxis attributed to the azole class of antifungals
  • No concurrent medical condition that may create an unacceptable additional risk for the patient during study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics

Chemotherapy

  • Not specified

Endocrine therapy

  • No concurrent hormonal contraceptives

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • At least 2 weeks since other prior non-FDA approved investigational drugs
  • No concurrent QTc prolonging medication (e.g., terfenadine, cisapride, quinidine, pimozide, or dofetilide)
  • No concurrent rifampin
  • No other concurrent experimental or systemic antifungal therapy
  • No concurrent agents containing amphotericin B
  • No other concurrent systemic azole or triazole antifungal agents
  • No concurrent echinocandins
  • Concurrent topical antifungals allowed
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00064311


Locations
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United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
Investigators
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Study Chair: Thomas J. Walsh, MD National Cancer Institute (NCI)
More Information
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ClinicalTrials.gov Identifier: NCT00064311    
Obsolete Identifiers: NCT00061555
Other Study ID Numbers: 030205
03-C-0205
CDR0000315356
First Posted: July 9, 2003    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012
Keywords provided by National Institutes of Health Clinical Center (CC):
infection
recurrent cutaneous T-cell non-Hodgkin lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult Burkitt lymphoma
recurrent adult Hodgkin lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
 noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II grade 3 follicular lymphoma
noncontiguous stage II mantle cell lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult Burkitt lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III grade 3 follicular lymphoma
stage III mantle cell lymphoma
stage IV grade 3 follicular lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Mycoses
Lymphoma
Breast Neoplasms
Neoplasms
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Preleukemia
Neuroblastoma
Neoplasms, Germ Cell and Embryonal
Trophoblastic Neoplasms
Gestational Trophoblastic Disease
Myelodysplastic Syndromes
 Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Syndrome
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease
Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases
Hemostatic Disorders
Vascular Diseases