Antiviral Therapy in Treating Patients Who Have or Are at Risk of Developing Kaposi's Sarcoma Related to HIV - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00020319

Purpose

RATIONALE: Herpesvirus is found in many Kaposi's sarcoma lesions. Antiviral drugs act against many types of herpes viruses and may be an effective treatment for Kaposi's sarcoma.

PURPOSE: Phase II trial to study the effectiveness of combining antiviral drugs in treating patients with HIV who have or are at risk of developing Kaposi's sarcoma.

Condition	Intervention	Phase
Sarcoma	Procedure: antiviral therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Study of the Effects of Potent Anti-HIV Therapy on Parameters Hypothesized to be Related to the Pathogenesis of Kaposi's Sarcoma (KS) in HIV-Infected Individuals

Resource links provided by NLM:

MedlinePlus related topics: AIDS Cancer Kaposi's Sarcoma Soft Tissue Sarcoma

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Effect of therapy on tumor pathogenesis as measured by vascular endothelial growth factor and Kaposi's sarcoma associated herpes virus levels at 3 months [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response based on tumor measurements every 3 months [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	November 2000

Detailed Description:

OBJECTIVES:

Determine the effects of potent antiretroviral therapy on specific factors potentially linked to the control or pathogenesis of Kaposi's sarcoma (KS), such as serum viral interleukin-6 and plasma vascular endothelial growth factor levels, in patients with KS or who are at risk for KS by virtue of being infected with KS-associated herpes virus/human herpes virus-8 (KSHV/HHV-8).
Determine the effect of the initiation of antiretroviral therapy on the KSHV/HHV-8 load in patients who are coinfected with KSHV/HHV-8 and HIV.
Determine the effect of antiretroviral therapy on other parameters believed to be involved in the pathogenesis of KS, including interleukin-8, cellular interleukin-6, serum-inducible protein 10, and basic fibroblast growth factor, in these patients.
Determine the KS response in patients treated with highly active antiretroviral therapy.

OUTLINE: Patients are stratified according to disease status (diagnosis of KS vs KS-associated herpes virus positive but without diagnosis of KS).

Each patient receives an individualized regimen comprising standard antiretroviral drugs. Antiretroviral therapy continues in the absence of progression of KS requiring chemotherapy or other specific therapy, development of another malignancy requiring chemotherapy or immunotherapy, or inability to maintain HIV RNA levels below 15,000 copies/mL on at least 2 sequential evaluations even when the therapeutic changes to optimize antiretroviral agents have been exhausted.

PROJECTED ACCRUAL: A total of 24 patients (9 with KS and 15 at risk for developing KS) will be accrued for this study.

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of Kaposi's sarcoma (KS) OR
KS-associated herpes virus/human herpes virus-8 positive
HIV positive
Ineligible if antiretroviral therapy not in best interest of patient

PATIENT CHARACTERISTICS:

Age:

13 and over

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

No condition that periodically requires immunosuppressive therapy (e.g., asthma)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

At least 4 weeks since prior cytokine therapy
No concurrent cytokines
No concurrent antiangiogenic agents
No other concurrent immune-based therapy

Chemotherapy:

No concurrent cytotoxic chemotherapy

Endocrine therapy:

At least 4 weeks since prior corticosteroid therapy
Concurrent physiologic anabolic steroid replacement therapy allowed
No concurrent supraphysiologic doses of corticosteroid therapy

Radiotherapy:

Not specified

Surgery:

Not specified

Other:

At least 4 weeks since prior specific anti-KS therapy
No concurrent specific anti-KS therapy except local therapy to small lesions of cosmetic significance not included in KS assessment field
No concurrent antiherpes therapy with potent anti-KS-associated herpes virus activity (e.g., foscarnet, cidofovir)
No concurrent therapy for HIV-associated opportunistic complications

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020319

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Robert Yarchoan, MD

NCI - HIV and AIDS Malignancy Branch

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068289, NCI-00-C-0193
Study First Received:	July 11, 2001
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00020319 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

AIDS-related Kaposi sarcoma

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms by Histologic Type
Sarcoma, Kaposi
Antiviral Agents
Pharmacologic Actions
Herpesviridae Infections
Virus Diseases

Neoplasms, Connective and Soft Tissue
Neoplasms
Therapeutic Uses
Sarcoma
Neoplasms, Vascular Tissue
DNA Virus Infections

ClinicalTrials.gov processed this record on November 30, 2009