Valproic Acid in Treating Patients With Kaposi's Sarcoma
Information source: AIDS Malignancy Consortium
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sarcoma
Intervention: valproic acid (Drug)
Phase: N/A
Status: Completed
Sponsored by: AIDS Malignancy Consortium Official(s) and/or principal investigator(s):
Richard F. Ambinder, MD, PhD, Study Chair, Affiliation: Sidney Kimmel Comprehensive Cancer Center
Mary Jo Lechowicz, MD, Study Chair, Affiliation: Georgia Cancer Center for Excellence at Grady Memorial Hospital
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.
Clinical Details
Official title: A Pilot Trial Of Valproic Acid In Patients With Kaposi's Sarcoma
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Toxicity-related discontinuation rateLytic induction rate Clinical response rate Accelerated KS progression rate
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 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California 90095-1781, United States
Veterans Affairs Medical Center - San Diego, San Diego, California 92161, United States
UCSF Comprehensive Cancer Center, San Francisco, California 94143-0324, United States
Georgia Cancer Center for Excellence at Grady Memorial Hospital, Atlanta, Georgia 30303, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois 60611-3013, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231-2410, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States
Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis, Missouri 63110, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York 10461, United States
Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States
Case Comprehensive Cancer Center, Cleveland, Ohio 44106-5065, United States
Joan Karnell Cancer Center at Pennsylvania Hospital, Philadelphia, Pennsylvania 19106, United States
Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center, Seattle, Washington 98111, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: February 2005
Last updated: August 27, 2014
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