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Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment Clinical research trials and Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment. Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment  Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment
Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment
For Condition: Lymphoma,Testicular Cancer,Breast Cancer,Leukemia,ovarian epithelial cancer,kidney tumor,Eye Cancer,Multiple Myeloma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: RATIONALE: Caspofungin acetate or amphotericin B liposomal may be effective in preventing or controlling fever and neutropenia caused by chemotherapy, bone marrow transplantation, or peripheral stem cell transplantation. It is not yet known whether caspofungin acetate or amphotericin B liposomal is more effective for treating these side effects. PURPOSE: Randomized phase III trial to compare the effectiveness of caspofungin acetate with that of amphotericin B liposomal in treating patients who have persistent fever and neutropenia after receiving anticancer therapy.
Details: OBJECTIVES: I. Compare the number of successful treatment outcomes among patients treated with caspofungin acetate vs amphotericin B liposomal for persistent fever and neutropenia following cancer therapy, in terms of survival for 7 days after study drug, resolution of fever, treatment of any baseline fungal infection, absence of breakthrough fungal infection during and for 7 days after study drug, and absence of study drug discontinuation due to toxicity or lack of efficacy. II. Compare the incidence of nephrotoxicity in patients treated with these regimens. III. Compare the incidence of infusion-related adverse events within 1 hour of the infusion in patients treated with these regimens. IV. Compare the incidence of treatment discontinuation due to drug-related adverse events, frequency of drug-related events, number of breakthrough fungal infections, and number of successfully treated baseline fungal infections in patients treated with these regimens. V. Compare incidence of required dose increase due to inadequate clinical response in patients treated with these regimens. VI. Compare the time to resolution of fever in patients treated with these regimens. PROTOCOL OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to high-risk (prior allogeneic bone marrow transplantation or prior chemotherapy for relapse of acute leukemia) vs low-risk and prior prophylactic antifungal therapy during chemotherapy (yes vs no). Patients are randomized to one of two treatment arms. Arm I: Patients receive caspofungin acetate IV over 1 hour followed by placebo IV over 2 hours. Arm II: Patients receive placebo IV over 1 hour followed by amphotericin B liposomal IV over 2 hours. Treatment repeats daily for up to 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed at 7 and 14 days after study drug discontinuation. PROJECTED ACCRUAL: A total of 1060 patients (530 per arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 16 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Leukemia, lymphoma, or other cancer that has been previously treated with chemotherapy or bone marrow or peripheral blood stem cell transplantation - Absolute neutrophil count less than 500/mm3 for past 96 hours and not expected to recover in next 48 hours - Received at least 96 hours of parenteral systemic antibacterial therapy - Fever greater than 38.0 degrees Celsius - Adequately managed bacterial infection allowed if all of the following are true: Negative blood cultures; Received at least 5 days of antibiotics to which any bacterial isolates are sensitive Surgical drainage of any abscess fluid or surgical debridement of infected tissues Removal of infected catheters - No invasive fungal infection - Not previously enrolled on this study --Prior/Concurrent Therapy-- - Biologic therapy: See Disease Characteristics - Chemotherapy: See Disease Characteristics; No concurrent investigational antineoplastic therapy - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: Not specified - Other: At least 10 days since prior parenteral amphotericin B; At least 14 days since prior investigational antibiotic, antifungal, or immunosuppressive drug; No concurrent rifampin or cyclosporine; No other concurrent investigational antibiotic, antifungal, or immunosuppressive drug; No concurrent alcohol --Patient Characteristics-- - Age: 16 and over - Performance status: Karnofsky 30-100% - Life expectancy: At least 5 days - Hematopoietic: Platelet count at least 5,000/mm3 INR no greater than 1.6 (no greater than 4.0 if receiving anticoagulants) - Hepatic: Bilirubin no greater than 3 times upper limit of normal (ULN); AST or ALT no greater than 5 times ULN; Alkaline phosphatase no greater than 3 times ULN; No acute hepatitis or cirrhosis - Renal: Not specified - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective barrier contraception; No allergy, hypersensitivity, or prior serious reaction to any echinocandin antifungal or amphotericin B formulation; No other condition or illness that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KentSepkowitz, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000068400; MSKCC-00085,MERCK-026-01,NCI-G00-1898
Study Start Date: August 2000
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00008359
Other Lymphoma Studies:
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2. Irinotecan Plus Cyclosporine and Phenobarbital in Treating Patients With Solid Tumors or Lymphoma
3. Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
4. Suberoylanilide Hydroxamic Acid in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy
5. Amifostine to Protect From the Side Effects of Peripheral Stem Cell Transplantation in Treating Patients With High-Risk or Relapsed Solid Tumors
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Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment
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