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A Pilot Trial Of Valproic Acid In Patients With Kaposi's Sarcoma


N/A
18 Years
N/A
Not Enrolling
Both
Sarcoma

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Trial Information

A Pilot Trial Of Valproic Acid In Patients With Kaposi's Sarcoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity-related discontinuation rate

Outcome Time Frame:

28 days

Safety Issue:

Yes

Principal Investigator

Richard F. Ambinder, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000349348

NCT ID:

NCT00075777

Start Date:

February 2005

Completion Date:

February 2008

Related Keywords:

  • Sarcoma
  • recurrent Kaposi sarcoma
  • AIDS-related Kaposi sarcoma
  • Sarcoma, Kaposi
  • Sarcoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Veterans Affairs Medical Center - San DiegoSan Diego, California  92161
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Joan Karnell Cancer Center at Pennsylvania HospitalPhiladelphia, Pennsylvania  19107
Georgia Cancer Center for Excellence at Grady Memorial HospitalAtlanta, Georgia  30303
Floyd & Delores Jones Cancer Institute at Virginia Mason Medical CenterSeattle, Washington  98111