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

Sarcoma Clinical Trial

Official title:

Treatment of HIV-Related Kaposi's Sarcoma and Stage I-III Slow-Proliferative Disease With Highly Active Antiretroviral Therapy (HAART)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00003419
• Other study ID #: CDR0000066438
• Secondary ID: ITA-GICAT-POS2EU
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: September 19, 2013
• Start date: June 1998

Study information

• Verified date: November 2001
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma
• Sarcoma, Kaposi

Intervention

Procedure:
• antiviral therapy

Locations

Country	Name	City	State
Italy	Centro di Riferimento Oncologico - Aviano	Aviano

Sponsors (1)

Lead Sponsor	Collaborator
Centro di Riferimento Oncologico - Aviano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy			No