Trial record 1 of 2 for:    ravuconazole
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Ravuconazole in Preventing Fungal Infections in Patients Undergoing Allogeneic Stem Cell Transplantation

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00064311
First received: July 8, 2003
Last updated: March 7, 2012
Last verified: March 2012
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Study Start Date: June 2003
Study Completion Date: September 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064311

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Study Chair: Thomas J. Walsh, MD National Cancer Institute (NCI)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00064311     History of Changes
Obsolete Identifiers: NCT00061555
Other Study ID Numbers: 030205, 03-C-0205, CDR0000315356
Study First Received: July 8, 2003
Last Updated: March 7, 2012
Health Authority: United States: Federal Government

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:
Breast Neoplasms
Neoplasms
Leukemia
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Mycoses
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Neuroblastoma
Ovarian Neoplasms
Trophoblastic Neoplasms
Lymphoma, Large-Cell, Immunoblastic
Neoplasms, Germ Cell and Embryonal
Gestational Trophoblastic Neoplasms
Myelodysplastic-Myeloproliferative Diseases
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias

ClinicalTrials.gov processed this record on July 22, 2014