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Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel from Baker Norton Pharmaceuticals 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 Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel from Baker Norton Pharmaceuticals conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel from Baker Norton Pharmaceuticals Clinical research trials and Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel from Baker Norton Pharmaceuticals 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 Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel from Baker Norton Pharmaceuticals. Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel from Baker Norton Pharmaceuticals 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 Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel from Baker Norton Pharmaceuticals clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel from Baker Norton Pharmaceuticals 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.
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Home > "P" Clinical Trials Conditions > Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel from Baker Norton Pharmaceuticals  Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel from Baker Norton Pharmaceuticals
Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel from Baker Norton Pharmaceuticals
For Condition: Sarcoma, Kaposi,HIV Infections
Status: Completed
Sponsor(s): Baker Norton Pharmaceuticals ,
Synopsis: To determine response rate, median time to tumor progression, qualitative and quantitative toxicity and reversibility of toxicity in patients with advanced refractory AIDS-associated Kaposi's sarcoma (KS) administered a 3-hour infusion of paclitaxel every 14 days. To evaluate the clinical benefit of paclitaxel in this patient population by evaluating self-reported responses to the Symptom Distress Scale and by documenting and evaluating any changes in their lymphedema, pain and disfiguring facial lesions.
Details: Patients are treated with paclitaxel intravenously every 2 weeks up to 10 courses. Patients who achieve a complete response receive 2 additional courses those who achieve partial response or stabilization, continue therapy until progression.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - Microscopically confirmed diagnosis of KS associated with HIV for which systematic therapy is medically indicated by the presence of at least one of the following: A. >= 25 mucocutaneous (mouth or skin) lesions. B. Symptomatic visceral involvement. C. Symptomatic lymphedema (pain). - Minimum of 5 clearly measurably cutaneous lesions by physical exam or measurable disease by X-ray, CT or MRI. - Failed at least one systemic chemotherapy regimen. Exclusion Criteria Co-existing Condition: Patients with the following conditions and symptoms are excluded: - Less than 2 weeks since major surgery. - Serious uncontrolled infection. NOTE: - Must be ruled out by thorough work-up in patients with unexplained fevers, night sweats, or involuntary weight loss of more than 10% normal weight. - Leukopenia. - Thrombocytopenia. Patients with the following prior conditions are excluded: - History of angina or myocardial infarction within the past 6 months. - Second degree or third degree atrioventricular block without a pacemaker. - Congestive heart failure (poorly controlled). - History of prior malignancy except: Completely excised in situ, carcinoma of the cervix or nonmelanomatous skin cancer. Curatively treated other malignancy with no evidence of disease for at least 5 years. Prior Medication: Excluded: Prior taxane therapy. Required: - At least one systemic chemotherapy regimen that failed to maintain significant benefit. NOTE: - Intralesional chemotherapy regimens are not considered as prior chemotherapy. - At least 2 weeks since last dose of prior systemic chemotherapy.
Total Enrollment:
Location and Contact Information:
Massachusetts Gen Hosp / AIDS Oncology Research
Boston, Massachusetts, 02114
United States
Additional Information:
Study ID Numbers: 273A; IX-110-081
Study Start Date:
Record last reviewed: June 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002189
Other Sarcoma, Kaposi Studies:
1. An Escalating Dose Tolerance Trial of BG8962 (rCD4) in Patients Who Are HIV Antibody Positive
2. Anti-HIV Drugs During Pregnancy
3. Safety of an HIV Vaccine (AVX101) in HIV Uninfected Volunteers in the United States and South Africa
4. The Safety and Effectiveness of PMPA Prodrug in HIV-Infected Patients
5. Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease
Related Studies:
Other Sarcoma, Kaposi Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel from Baker Norton Pharmaceuticals
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