Status:
COMPLETED
Valproic Acid in Treating Patients With Kaposi's Sarcoma
Lead Sponsor:
AIDS Malignancy Consortium
Collaborating Sponsors:
National Cancer Institute (NCI)
The Emmes Company, LLC
Conditions:
Sarcoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
OBJECTIVES: Primary * Determine the safety of valproic acid in patients with Kaposi's sarcoma. * Determine the effects of this drug on human herpes virus 8 (KSHV) gene expression using polymerase ch...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00075777
Start Date
February 1 2005
End Date
February 1 2008
Last Update
August 29 2014
Active Locations (13)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
2
Veterans Affairs Medical Center - San Diego
San Diego, California, United States, 92161
3
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94143-0324
4
Georgia Cancer Center for Excellence at Grady Memorial Hospital
Atlanta, Georgia, United States, 30303