A Pilot Trial Of Valproic Acid In Patients With Kaposi's Sarcoma

Inclusion Criteria

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 requiring cytotoxic therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 2 weeks since prior biologic therapy for KS

Chemotherapy

- More than 2 weeks since prior chemotherapy for KS

- No concurrent systemic cytotoxic chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- More than 2 weeks since prior radiotherapy for KS

Surgery

- Not specified

Other

- More than 2 weeks since other prior antineoplastic or local therapy for KS

- More than 2 weeks since prior investigational therapy for KS

- More than 60 days since prior local therapy to a KS-marker lesion unless lesion has
clearly progressed since therapy

- More than 1 year since prior valproic acid

- Concurrent antiretroviral therapy allowed provided regimen has been stable for at
least 4 weeks

- No concurrent zidovudine

- No other concurrent KS-specific therapy

- No other concurrent investigational drugs, other than IND-approved antiretroviral
agents