Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-24 @ 3:07 PM
NCT ID:
NCT00521092
Eligibility Criteria:
Inclusion Criteria:
* ECOG performance status 0-1
* Documented HIV-serostatus \[HIV-seronegative (endemic KS) or HIV-seropositive (epidemic/AIDS KS)\]
* No symptomatic organ involvement, visceral crisis, or life-threatening disease (e.g., extensive or symptomatic pulmonary disease or reticuloendothelial system/hepatic involvement) for which aggressive double- or triple-drug combination chemotherapy for urgent cytoreduction is indicated (i.e., doxorubicin hydrochloride, bleomycin, and vinblastine \[ABV\], BV, or AV)
* Histologically confirmed Kaposi sarcoma
* Platelet count \> 75,000/uL
* Life expectancy \>= 24 weeks
* Absolute granulocyte count \> 1,000/uL
* Hemoglobin \> 8.0 g/dL OR hematocrit \> 24%
* Serum creatinine =\< 2.0 mg/dL
* AST \< 3 times normal
* Fertile patients must use effective contraception
* Normal clinical cardiac examination and normotensive (systolic and diastolic BP \< 140/90 mm Hg) documented on at least two occasions prior to enrollment
* Normal ECG including QTc interval \< 500 msec
* Normal echocardiogram prior to enrollment (if feasibly possible)
* Must be able to swallow study medication
* No acute infections \[Patients with chronic infections (e.g., malaria, tuberculosis, parasitic infections, or hepatitis B or C) that may be active but under treatment are allowed provided all eligibility criteria are met\]
* At least 60 days since prior local treatment modalities (e.g., resection, cryosurgery, radiotherapy, or intralesional therapy) AND treated lesions must have clearly progressed following such therapies if the lesions are to be used as an index lesion
* No prior systemic anticancer therapy for Kaposi sarcoma
* Concurrent antiretroviral therapy required for HIV-seropositive patients (Patient must be on a stable regimen 8 weeks prior to study enrollment--An exception may be made for patients who have exhausted or are intolerant to all available regimens)
* No other concurrent systemic anticancer therapy
* Patient resides in Uganda or Kenya, East Africa
Exclusion Criteria:
* Pregnant or nursing
* Baseline diarrhea \>= grade 2 by CTCAE
* Uncontrolled intercurrent illness including, but not limited to, any of the following:
* Ongoing or acute active infection
* Symptomatic congestive heart failure (NYHA class III or IV heart disease)
* Unstable angina pectoris
* Uncontrolled intercurrent illness including, but not limited to, any of the following: 1) Cardiac arrhythmia (i.e., history of serious ventricular arrhythmia, ventricular fibrillation, or ventricular tachycardia \>= 3 beats in a row OR QTc \>= 500 msec) 2) Psychiatric illness or social situation that would limit compliance with study requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00521092
Study Brief:
Protocol Section:
NCT00521092