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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 rate

Lytic 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

Page last updated: August 20, 2015

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