Valproic acid in Sarcoma - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Sarcoma

Intervention / Treatment

Drug: valproic acid

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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Los Angeles, California, United States, 90095-1781
    - Jonsson Comprehensive Cancer Center at UCLA
  - San Diego, California, United States, 92161
    - Veterans Affairs Medical Center - San Diego
  - San Francisco, California, United States, 94143-0324
    - UCSF Comprehensive Cancer Center
- Georgia
  - Atlanta, Georgia, United States, 30303
    - Georgia Cancer Center for Excellence at Grady Memorial Hospital
- Illinois
  - Chicago, Illinois, United States, 60611-3013
    - Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- Maryland
  - Baltimore, Maryland, United States, 21231-2410
    - Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Beth Israel Deaconess Medical Center
- Missouri
  - Saint Louis, Missouri, United States, 63110
    - Siteman Cancer Center at Barnes-Jewish Hospital
- New York
  - Bronx, New York, United States, 10461
    - Albert Einstein Cancer Center at Albert Einstein College of Medicine
  - New York, New York, United States, 10021
    - Memorial Sloan-Kettering Cancer Center
- Ohio
  - Cleveland, Ohio, United States, 44106-5065
    - Case Comprehensive Cancer Center
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19106
    - Joan Karnell Cancer Center at Pennsylvania Hospital
- Washington
  - Seattle, Washington, United States, 98111
    - Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Toxicity-related discontinuation rate Time Frame: 28 days	28 days
Lytic induction rate Time Frame: 28 days	28 days
Clinical response rate Time Frame: 28 days	28 days
Accelerated KS progression rate Time Frame: 28 days	28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AIDS Malignancy Consortium

Collaborators

National Cancer Institute (NCI)

The Emmes Company, LLC

Investigators

Study Chair: Richard F. Ambinder, MD, PhD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Chair: Mary Jo Lechowicz, MD, Georgia Cancer Center for Excellence at Grady Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

January 9, 2004

First Submitted That Met QC Criteria

January 12, 2004

First Posted (Estimate)

January 13, 2004

Study Record Updates

Last Update Posted (Estimate)

August 29, 2014

Last Update Submitted That Met QC Criteria

August 27, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

AMC-038
U01CA070019 (U.S. NIH Grant/Contract)
CDR0000349348 (Other Identifier: NCI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Valproic Acid in Treating Patients With Kaposi's Sarcoma

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