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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
breast cancer
familial acute myeloid leukemia with mutated CEBPA
neuroblastoma
primary myelofibrosis
MedlinePlus related topics:
Acute Myeloid Leukemia
Breast Cancer
Cancer
Cancer and Pregnancy
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Fungal Infections
Leukemia
Lymphoma
Molds
Multiple Myeloma
Myelodysplastic Syndromes
Neuroblastoma
Ovarian Cancer
U.S. FDA Resources
Further study details as provided by National Institutes of Health Clinical Center (CC):
| Study Start Date: | June 2003 |
| Study Completion Date: | September 2004 |
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
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
Additional 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 May 19, 2013