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Antiviral Therapy in Treating Patients Who Have or Are at Risk of Developing Kaposi's Sarcoma Related to HIV
This study is ongoing, but not recruiting participants.
Study NCT00020319   Information provided by National Cancer Institute (NCI)
First Received: July 11, 2001   Last Updated: February 6, 2009   History of Changes

July 11, 2001
February 6, 2009
November 2000
 
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 ]
Effect of therapy on tumor pathogenesis as measured by vascular endothelial growth factor and Kaposi's sarcoma associated herpes virus levels at 3 months
Complete list of historical versions of study NCT00020319 on ClinicalTrials.gov Archive Site
Response based on tumor measurements every 3 months [ Designated as safety issue: No ]
Response based on tumor measurements every 3 months
 
Antiviral Therapy in Treating Patients Who Have or Are at Risk of Developing Kaposi's Sarcoma Related to HIV
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

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.

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.

Phase II
Interventional
Treatment
Sarcoma
Procedure: antiviral therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
24
 
 

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
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00020319
 
CDR0000068289, NCI-00-C-0193
National Cancer Institute (NCI)
 
Principal Investigator: Robert Yarchoan, MD NCI - HIV and AIDS Malignancy Branch
National Cancer Institute (NCI)
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP