Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Valproic Acid in Treating Patients With Kaposi’s Sarcoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Treatment	Completed	18 and over	NCI	AMC-038 NCT00075777

Objectives

Primary

1. Determine the safety of valproic acid in patients with Kaposi’s sarcoma.
2. Determine the effects of this drug on human herpes virus 8 (KSHV) gene expression using polymerase chain reaction and immunohistochemistry in these patients.

Secondary

1. 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.
2. Determine clinical response in patients treated with this drug.

Entry 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/mm³

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

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/mm³
• Platelet count ≥ 75,000/mm³

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

Expected Enrollment

A total of 15-30 patients will be accrued for this study within 1 year.

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.

Trial Contact Information

Trial Lead Organizations

AIDS Associated Malignancies Clinical Trials Consortium

Richard Ambinder, MD, PhD, Protocol co-chair		Ph: 410-955-5617
Mary Jo Lechowicz, MD, Protocol chair		Ph: 404-489-9000 Email: mary_jo_lechowicz@emoryhealthcare.org

Registry Information
Official Title		A Pilot Trial Of Valproic Acid In Patients With Kaposi's Sarcoma
Trial Start Date		2005-02-01
Trial Completion Date		2008-02-29
Registered in ClinicalTrials.gov		NCT00075777
Date Submitted to PDQ		2003-12-04
Information Last Verified		2007-05-20
NCI Grant/Contract Number		CA70019

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