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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00064311 |
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 |
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Breast Cancer Cancer-Related Problem/Condition Chronic Myeloproliferative Disorders Gestational Trophoblastic Tumor Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Neuroblastoma Ovarian Cancer Testicular Germ Cell Tumor |
Drug: ravuconazole |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Open Label |
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 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 |
Study Chair: | Thomas J. Walsh, MD | NCI - Pediatric Oncology Branch |
Study ID Numbers: | CDR0000315356, NCI-03-C-0205 |
Study First Received: | July 8, 2003 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00064311 |
Health Authority: | United States: Federal Government |
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 |
Blast Crisis Chronic myelogenous leukemia Hodgkin lymphoma, adult Lymphoma, small cleaved-cell, diffuse Urogenital Neoplasms Lymphoma, large-cell, immunoblastic Preleukemia Hemorrhagic Disorders Neoplasm Metastasis Neuroepithelioma Endocrine Gland Neoplasms Myelodysplastic syndromes Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
Blood Coagulation Disorders Genital Neoplasms, Female Acute myelogenous leukemia Breast Neoplasms Testicular Neoplasms Leukemia, Myeloid Myelodysplastic myeloproliferative disease Leukemia, Myeloid, Accelerated Phase B-cell lymphomas Lymphoma, Non-Hodgkin Hairy cell leukemia Neoplasms, Glandular and Epithelial Precancerous Conditions Blood Protein Disorders Lymphoma, Follicular |
Neoplasms by Histologic Type Disease Pregnancy Complications, Neoplastic Immune System Diseases Neoplasms, Nerve Tissue Infection Adnexal Diseases |
Neoplasms Neoplasms by Site Pathologic Processes Syndrome Cardiovascular Diseases Neoplasms, Neuroepithelial |