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 range18 Years
SexALL
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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…