Valproic Acid in Treating Patients With Kaposi's Sarcoma (NCT00075777) | Clinical Trial Compass
CompletedNot Applicable
Valproic Acid in Treating Patients With Kaposi's Sarcoma
United States19 participantsStarted 2005-02
Plain-language summary
RATIONALE: Valproic acid may help stop the growth of Kaposi's sarcoma cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: This clinical trial is studying valproic acid in treating patients with HIV-related Kaposi's sarcoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed HIV-related Kaposi's sarcoma (KS)
* Disease involving the skin and/or lymph nodes
* No symptomatic visceral disease
* No oral KS as the only site of disease
* Slowly progressive or stable disease allowed
* Slow progression defined as fewer than 5 new lesions per month
* Must have documented HIV infection by positive ELISA, western Blot, or viral load determination
* CD4 T-cell count \> 50/mm\^3
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 60-100%
Life expectancy
* At least 3 months
Hematopoietic
* Hemoglobin ≥ 8.0 g/dL
* Absolute neutrophil count ≥ 750/mm\^3
* Platelet count ≥ 75,000/mm\^3
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)\*
* AST and ALT ≤ 3 times ULN
* Albumin \> 2.5 g/dL NOTE: \*Elevated total bilirubin (≤ 3.5 mg/dL) secondary to indinavir therapy allowed provided the direct bilirubin is normal
Renal
* Creatinine \< 1.5 times ULN
Cardiovascular
* No prior myocardial infarction
* No evidence of cardiac ischemia
Other
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study participation
* No prior lactic acidosis \> 2.0 mmoles/L
* No prior lipoatrophy or hypercholesterolemia secondary to retroviral treatment
* No concurrent, acute, active opportunistic infection other than oral thrush or genital herpes within the past 14 days
* No other concurrent neoplasm req…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.