|
Doxorubicin in Treating Patients With AIDS-Related Kaposi's Sarcoma 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 Doxorubicin in Treating Patients With AIDS-Related Kaposi's Sarcoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Doxorubicin in Treating Patients With AIDS-Related Kaposi's Sarcoma Clinical research trials and Doxorubicin in Treating Patients With AIDS-Related Kaposi's Sarcoma 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 Doxorubicin in Treating Patients With AIDS-Related Kaposi's Sarcoma. Doxorubicin in Treating Patients With AIDS-Related Kaposi's Sarcoma 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 Doxorubicin in Treating Patients With AIDS-Related Kaposi's Sarcoma clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Doxorubicin in Treating Patients With AIDS-Related Kaposi's Sarcoma 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 > "D" Clinical Trials Conditions > Doxorubicin in Treating Patients With AIDS-Related Kaposi's Sarcoma  Doxorubicin in Treating Patients With AIDS-Related Kaposi's Sarcoma
Doxorubicin in Treating Patients With AIDS-Related Kaposi's Sarcoma
For Condition: childhood skin cancer,epidemic Kaposi's sarcoma
Status: Completed
Sponsor(s): Roswell Park Cancer Institute ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether doxorubicin is more effective than daunorubicin for AIDS -related Kaposi's sarcoma. PURPOSE: Randomized double-blinded phase III trial to determine if doxorubicin is more effective than daunorubicin in treating patients who have AIDS-related Kaposi's sarcoma.
Details: OBJECTIVES: I. Evaluate the clinical benefit of doxorubicin HCl liposome (Doxil) compared to baseline status in the treatment of AIDS-related Kaposi's sarcoma. II. Determine tumor response to Doxil as a corollary to clinical benefit. III. Evaluate the safety of Doxil. PROTOCOL OUTLINE: This is a randomized, prospective, double blind, multicenter study. Patients are randomly assigned to receive doxorubicin HCl liposome (Doxil) or daunorubicin (DaunoXome) in a 3:1 ratio. Both Doxil and DauonoXome are given every 2 weeks for 6 courses by intravenous infusion over 60 minutes into a peripheral vein. PROJECTED ACCRUAL: 80 patients will be studied.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - AIDS-related Kaposi's sarcoma that requires systemic chemotherapy - One or more of the following (Kaposi's sarcoma- or AIDS-associated): Edema that impairs functional activity; Symptomatic, evaluable pulmonary Kaposi's sarcoma documented within 3 months before study; Symptomatic, evaluable GI Kaposi's sarcoma documented within 3 months before study; Moderate or severe pain despite the use of analgesics; Lesion(s) that patient feels are disfiguring and impair patient's self-image or daily activities; At least 5 bidimensionally measurable monocutaneous lesions --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 14 days since prior anti-Kaposi's sarcoma therapy; No prior Doxil or DaunoXome; No concurrent cytotoxic chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No concurrent radiation therapy - Surgery: Not specified - Other: Antiviral therapy allowed; Colony stimulating factors allowed; Erythropoietin allowed; Prophylactic therapy, maintenance therapy and treatment for HIV-associated opportunistic infections allowed --Patient Characteristics-- - Age: Not specified - Performance status: Karnofsky 40-100% - Life expectancy: At least 120 days - Hematopoietic: Neutrophil count at least 1,200 cells/mm3; Platelet count at least 75,000 cells/mm3; Hemoglobin at least 9.0 g/dL - Hepatic: Creatinine less than 2 times upper limit of normal (ULN); Bilirubin less than 2 times ULN - Renal: Not specified - Cardiovascular: Cardiac ejection fraction at least 50%; No histopathological evidence of antracycline-induced cardiomyopathy - Pulmonary: No significant non-Kaposi's sarcoma associated pulmonary insufficiency (defined as oxygen saturation less than 90%) - Other: Not pregnant or nursing; Fertile women must be using medically proven method of birth control; No opportunistic infection in the past 4 weeks; No other active malignancies except basal or squamous cell carcinoma of the skin or in situ cervical or anal carcinoma; No neuropsychiatric history or altered mental status that prevents informed consent or compliance with protocol requirements
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LawrenceLeichman, Study Chair, Roswell Park Cancer Institute
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Additional Information:
Study ID Numbers: CDR0000065520; RPCI-DS-96-28,NCI-G97-1241,SEQUUS-30-38
Study Start Date: November 1996
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002985
Other Childhood Skin Cancer Studies:
1. Thalidomide in Treating Patients With HIV-Associated Kaposi's Sarcoma
2. Flavopiridol in Treating Patients With HIV-Related Kaposi's Sarcoma
3. BMS-275291 in Treating Patients With HIV-Related Kaposi's Sarcoma
4. Valproic Acid in Treating Patients With Kaposi’s Sarcoma
5. Antiviral Therapy in Treating Patients With Kaposi's Sarcoma With or Without HIV Infection
Related Studies:
Other childhood skin cancer Clinical Trials
Other New York Clinical Trials
Other Buffalo Clinical Trials
Doxorubicin in Treating Patients With AIDS-Related Kaposi's Sarcoma
|
|
|
|
|
|
|
|
