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Lead
Baker Norton Pharmaceuticals
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel From Baker Norton Pharmaceuticals
