Low-Dose Oral Etoposide for Relapsed or Progressed AIDS-Related Kaposi's Sarcoma Treatment
This study aims to evaluate the effectiveness of low-dose oral Etoposide as a treatment for individuals with AIDS-related Kaposi's Sarcoma that has either relapsed or progressed.
Etoposide
Blood-Borne Infections+21
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Etoposide may be at least as, or even more, effective and less myelotoxic when given in low doses over prolonged periods of time. Patients receive low-dose oral etoposide on days 1 through 7 of every 2-week cycle. Patients who achieve a complete or partial response after two cycles and have no toxicity greater than grade 2 may have their dose escalated for subsequent cycles. If there are no responses to therapy among the first 14 evaluable patients, the study will close; if there is at least one objective response to therapy among the first 14 evaluable patients, enrollment will continue until all 41 patients are enrolled. Patients continue therapy until maximal tumor response (either stable disease or complete response) is achieved or disease progression occurs.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.41 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.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 12 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 Concurrent Medication: Allowed: Maintenance therapy for opportunistic infections. Patients must have: HIV infection. Kaposi's sarcoma that has relapsed or progressed. Mucocutaneous lesions (15 or more) and/or symptomatic mucosal lesions and/or visceral Kaposi's sarcoma (symptomatic lymphedema qualifies patients in the absence of these three conditions). NO active acute opportunistic infections requiring treatment with myelosuppressive antibiotics (maintenance for OIs is permitted). Consent of parent or guardian if less than 18 years of age. NOTE: This study is approved for prisoner participation. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Other active malignancies except basal cell carcinoma of the skin, or carcinoma in situ of the cervix. Grade 3 or worse peripheral neuropathy. Altered mental status that would prevent informed consent or prevent study compliance. Patients with the following prior condition are excluded: Neuropsychiatric history. Prior Medication: Excluded: Prior etoposide. Any other anti-KS drugs within 14 days prior to study entry. Any investigational drug other than antiretrovirals within 14 days prior to study entry. Any prior investigational agent, if given as the ONLY prior treatment for KS. Prior Treatment: Excluded: Radiation therapy within 7 days prior to study entry. Continued alcohol consumption or continued intravenous drug use that would impair ability to comply with study requirements.
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 20 locations
Univ of Alabama at Birmingham
Birmingham, United StatesOpen Univ of Alabama at Birmingham in Google MapsK Norris Cancer Hosp / Los Angeles County - USC Med Ctr
Los Angeles, United StatesUniv of Southern California / LA County USC Med Ctr
Los Angeles, United StatesSan Francisco Gen Hosp
San Francisco, United States