Paclitaxel Treatment for Advanced Refractory Kaposi's Sarcoma in AIDS Patients
Paclitaxel
Blood-Borne Infections+21
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Massachusetts Gen Hosp / AIDS Oncology Research
Boston, United StatesOpen Massachusetts Gen Hosp / AIDS Oncology Research in Google Maps