Antiviral Therapy in Treating Patients With Slowly Progressing HIV-Related Kaposi's Sarcoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified November 2001 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT00003419

First Posted: January 27, 2003

Last Update Posted: September 20, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

National Cancer Institute (NCI)

Purpose

RATIONALE: HIV virus is found in the lesions of most patients with Kaposi's sarcoma, and may have a role in causing Kaposi's sarcoma. Antiviral therapy acts against the HIV virus and may be an effective treatment for Kaposi's sarcoma.

PURPOSE: This phase II trial is studying how well antiviral therapy works in treating patients with slowly progressing HIV-related Kaposi's sarcoma.

Condition	Intervention	Phase
Sarcoma	Procedure: antiviral therapy	Phase 2


Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Treatment of HIV-Related Kaposi's Sarcoma and Stage I-III Slow-Proliferative Disease With Highly Active Antiretroviral Therapy (HAART)

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Kaposi's Sarcoma Soft Tissue Sarcoma

Genetic and Rare Diseases Information Center resources: Soft Tissue Sarcoma Kaposi Sarcoma

U.S. FDA Resources

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

Primary Outcome Measures:

Efficacy


Estimated Enrollment:	25
Study Start Date:	June 1998

Detailed Description:

OBJECTIVES:

Determine the efficacy of highly active antiretroviral therapy (HAART) in treating patients with HIV-related stage I-III nonaggressive epidemic Kaposi's sarcoma.

OUTLINE: Patients receive therapy consisting of nucleoside analogues (RTI) and protease inhibitors (PI). Patients may receive either 2 RTIs or 2 RTIs plus 2 PIs. Treatment continues for 12 weeks, then progression is assessed.

Patients with stable or regressing Kaposi's sarcoma (KS) with a viral load of greater than 500 copies of RNA/mL may continue with the therapy (if the viral load has decreased by greater than 2 logs) or may modify therapy (if the viral load has decreased less than 2 logs). Patients with progressive disease may begin chemotherapy but continue to receive the antiretroviral therapy. Treatment continues for at least 48 weeks.

Patients are followed every 8 weeks until week 48.

PROJECTED ACCRUAL: This study will accrue a total of 14-25 patients.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Stage I-III (NYU) Kaposi's sarcoma that is slowly progressive
- Stable disease without progression in diameter of tumor or in number of lesions (less than 50% increase in 3 months)
- No progressive disease during or after treatment for Kaposi's sarcoma
Level of viral load detectable independently from CD4+ cells
No other active AIDS pathologies

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-3

Life expectancy:

Not specified

Hematopoietic:

WBC greater than 1500/mm3
Hemoglobin greater than 8 mg/dL

Hepatic:

Bilirubin less than 2.5 times normal
AST and ALT less than 5 times normal
Alkaline phosphatase less than 2.5 times normal

Renal:

Creatinine less than 2.5 times normal

Other:

No prior malignancy except carcinoma in situ of the cervix or nonmelanomatous skin cancer
No active cytomegalovirus, herpes simplex 1 or 2, or herpes zoster infection requiring treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

Not specified

Endocrine therapy:

Not specified

Radiotherapy:

Not specified

Surgery:

Not specified

Other

No prior antiretroviral therapy OR
No prior highly active antiretroviral therapy (HAART)
No concurrent acyclovir, ganciclovir, foscarnet, or cidofovir

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003419

Locations


Italy
Centro di Riferimento Oncologico - Aviano
Aviano, Italy, 33081

Sponsors and Collaborators

Centro di Riferimento Oncologico - Aviano

Investigators


Study Chair:	Umberto Tirelli, MD	Centro di Riferimento Oncologico - Aviano

More Information


ClinicalTrials.gov Identifier:	NCT00003419 History of Changes
Other Study ID Numbers:	CDR0000066438 ITA-GICAT-POS2 EU-97019
First Submitted:	November 1, 1999
First Posted:	January 27, 2003
Last Update Posted:	September 20, 2013
Last Verified:	November 2001

Keywords provided by National Cancer Institute (NCI):


AIDS-related Kaposi sarcoma

Additional relevant MeSH terms:


Sarcoma Sarcoma, Kaposi Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Herpesviridae Infections	DNA Virus Infections Virus Diseases Neoplasms, Vascular Tissue Antiviral Agents Anti-Infective Agents

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