Clinical trial · Interventional
Valproic Acid in Treating Patients With Kaposi's Sarcoma
A Pilot Trial Of Valproic Acid In Patients With Kaposi's Sarcoma
NCT00075777CI-TRIAL-00015507completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| valproic acid | Drug | Valproic Acid | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Toxicity-related discontinuation rate
- timeFrame
- 28 days
- measure
- Lytic induction rate
- timeFrame
- 28 days
- measure
- Clinical response rate
- timeFrame
- 28 days
- measure
- Accelerated KS progression rate
- timeFrame
- 28 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 agentsReferences
Publications (0)
Data not yet available
No reference posted for this study.