Valproic Acid in Treating Patients With Kaposi's Sarcoma
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sarcoma
Intervention: valproic acid (Drug); enzyme inhibitor therapy (Procedure); non-specific immune-modulator therapy (Procedure)
Phase: N/A
Status: Active, not recruiting
Sponsored by: AIDS Associated Malignancies Clinical Trials Consortium Official(s) and/or principal investigator(s):
Richard F. Ambinder, MD, PhD, 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: Treatment, Open Label
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
UCSF Comprehensive Cancer Center, San Francisco, California 94143-0324, United States
Veterans Affairs Medical Center - San Diego, San Diego, California 92161, 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: October 25, 2007
|
