Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel From Baker Norton Pharmaceuticals
Sarcoma, Kaposi, HIV Infections
About this trial
This is an interventional treatment trial for Sarcoma, Kaposi focused on measuring Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Paclitaxel, Treatment Outcome, Antineoplastic Agents, Phytogenic
Eligibility 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.
Sites / Locations
- Massachusetts Gen Hosp / AIDS Oncology Research