Valproic Acid in Treating Patients With Kaposi's Sarcoma
NCT ID: NCT00075777
Last Updated: 2014-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
19 participants
INTERVENTIONAL
2005-02-28
2008-02-29
Brief Summary
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PURPOSE: This clinical trial is studying valproic acid in treating patients with HIV-related Kaposi's sarcoma.
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Detailed Description
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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 chain reaction and immunohistochemistry in these patients.
Secondary
* Determine the effects of this drug on HIV, KSHV, and Epstein-Barr virus viral loads in the plasma and peripheral blood mononuclear cells of these patients.
* Determine clinical response in patients treated with this drug.
OUTLINE: This is an open-label, pilot, multicenter study.
Patients receive oral valproic acid twice daily on days 1-28 followed by a drug taper over 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 6 months.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 1 year.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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valproic acid
250 mg by mouth twice a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
The Emmes Company, LLC
INDUSTRY
AIDS Malignancy Consortium
NETWORK
Responsible Party
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Principal Investigators
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Richard F. Ambinder, MD, PhD
Role: STUDY_CHAIR
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Mary Jo Lechowicz, MD
Role: STUDY_CHAIR
Georgia Cancer Center for Excellence at Grady Memorial Hospital
Locations
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Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Veterans Affairs Medical Center - San Diego
San Diego, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Georgia Cancer Center for Excellence at Grady Memorial Hospital
Atlanta, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Joan Karnell Cancer Center at Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center
Seattle, Washington, United States
Countries
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Other Identifiers
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CDR0000349348
Identifier Type: OTHER
Identifier Source: secondary_id
AMC-038
Identifier Type: -
Identifier Source: org_study_id
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