|
Voriconazole With or Without Interferon gamma in Treating Patients With Aspergillosis or Other Fungal Infections Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Voriconazole With or Without Interferon gamma in Treating Patients With Aspergillosis or Other Fungal Infections conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Voriconazole With or Without Interferon gamma in Treating Patients With Aspergillosis or Other Fungal Infections Clinical research trials and Voriconazole With or Without Interferon gamma in Treating Patients With Aspergillosis or Other Fungal Infections healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Voriconazole With or Without Interferon gamma in Treating Patients With Aspergillosis or Other Fungal Infections. Voriconazole With or Without Interferon gamma in Treating Patients With Aspergillosis or Other Fungal Infections Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Voriconazole With or Without Interferon gamma in Treating Patients With Aspergillosis or Other Fungal Infections clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Voriconazole With or Without Interferon gamma in Treating Patients With Aspergillosis or Other Fungal Infections condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "V" Clinical Trials Conditions > Voriconazole With or Without Interferon gamma in Treating Patients With Aspergillosis or Other Fungal Infections  Voriconazole With or Without Interferon gamma in Treating Patients With Aspergillosis or Other Fungal Infections
Voriconazole With or Without Interferon gamma in Treating Patients With Aspergillosis or Other Fungal Infections
For Condition: Infection,unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Antifungals such as voriconazole may be effective in controlling fungal infections. Combining voriconazole with interferon gamma may be more effective than voriconazole alone in treating fungalinfections. PURPOSE: Randomizedphase II trial to compare the effectiveness of voriconazole with or without interferon gamma in treating patients who have aspergillosis or other fungal infections.
Details: OBJECTIVES: - Determine the safety profile of voriconazole and interferon gamma in patients with invasive aspergillosis or other filamentous fungal infections. - Compare the efficacy and possible heterogeneity in efficacy of voriconazole with or without interferon gamma across different patient sub-populations, in terms of designing a larger phase II or pivotal phase III study. - Determine the time to partial or complete response and rate of response (at weeks 6 and 12 or at end of treatment and follow-up) in patients receiving interferon gamma. - Compare the proportion of patients with at least a two-fold reduction in the galactomannan antigenemia titer at 6 and 12 weeks or at end of treatment with these regimens. - Determine surrogate immunologic markers for response to interferon gamma, functional integrity and anti-fungal activity of phagocytic cells (neutrophils, monocytes, and macrophages), and nonphagocytic effector cells (natural killer and T cells) in these patients. OUTLINE: This is a randomized, double-blind, multicenter, pilot study. Patients are stratified according to age (under 18 vs 18 and over) and absolute neutrophil count (less than 500/mm^3 vs at least 500/mm^3). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive voriconazole (IV over 80-120 minutes for the first 3 doses and orally every 12 hours for subsequent doses) 3 times per week and interferon gamma subcutaneously (SC) 3 times per week. - Arm II: Patients receive voriconazole as in arm I and placebo SC 3 times per week. In both arms, treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks. PROJECTED ACCRUAL: A total of 88 patients (44 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 2 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Proven or probable invasive aspergillosis or other filamentous fungal infection by cytology, histopathology, or culture within the past 7 days - Presenting with 1 of the following: - Cancer - Aplastic anemia - Inherited immunodeficiencies - Autoimmune deficiency disorders - Acquired immunodeficiencies - Recipient of autologous peripheral blood stem cell or bone marrow transplantation - CNS aspergillosis or other filamentous fungal infection allowed - No invasive zygomycosis infection PATIENT CHARACTERISTICS: Age - 2 and over Performance status - Not specified Life expectancy - At least 7 days Hematopoietic - Not specified Hepatic - ALT no greater than 5 times upper limit of normal Renal - Creatinine clearance at least 30 mL/min Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception - No prior significant CNS disorder (e.g., multiple sclerosis or uncontrolled seizures) - No prior grade 3 or 4 toxicity or severe allergic reaction to interferon gamma - No prior intolerance or hypersensitivity to voriconazole or other azoles - No acute or chronic graft-versus-host disease - No conditions that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No prior allogeneic peripheral blood or bone marrow transplantation - No concurrent interferon alfa Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - No prior solid organ transplantation Other - Prior voriconazole allowed - At least 24 hours since prior administration of any of the following: - Astemizole - Cisapride - Pimozide - Quinidine - Sirolimus - Terfenadine - Rifabutin - Ergot alkaloids - Sildenafil citrate - Amiodarone - Flecainide - Systemic lidocaine - More than 14 days since prior long-acting barbiturates, carbamazepine, or rifampin - No other concurrent systemic antifungal drugs - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThomasWalsh, Study Chair, Pediatric Oncology Branch
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Shands Cancer Center at the University of Florida Health Science Center *Recruiting*
Gainesville, Florida, 32610-100277
United States
Recruiting John Wingard 352-846-2814
University of Arkansas for Medical Sciences *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Elias Anaissie 501-686-8250
Additional Information:
Study ID Numbers: CDR0000298887; NCI-03-C-0111
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00059878
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation
2. Levofloxacin to Prevent Infection Following Chemotherapy in Treating Patients With Solid Tumors or Lymphoma
3. Vaccine Therapy in Preventing Flu in Children With Acute Lymphoblastic Leukemia
4. Comparison of Two Test Methods-NASBA and Antigenemia-for Detecting Cytomegalovirus Infection
5. Chemotherapy and Peripheral Stem Cell Transplantation Followed By Immunotherapy in Treating Patients With Multiple Myeloma
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Florida Clinical Trials
Other Gainesville Clinical Trials
Voriconazole With or Without Interferon gamma in Treating Patients With Aspergillosis or Other Fungal Infections
|
|
|
|
|
|
|
|
