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

NCT ID: NCT00003419

Last Updated: 2013-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-06-30

Brief 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.

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.

Conditions

Sarcoma

Keywords

AIDS-related Kaposi sarcoma

Study Design

• Primary Study Purpose: TREATMENT

Interventions

antiviral therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro di Riferimento Oncologico - Aviano

OTHER

Sponsor Role: lead

Principal Investigators

Umberto Tirelli, MD

Role: STUDY_CHAIR

Centro di Riferimento Oncologico - Aviano

Locations

Centro di Riferimento Oncologico - Aviano

Aviano, , Italy

Countries

Italy

Other Identifiers

ITA-GICAT-POS2

Identifier Type: -

Identifier Source: secondary_id

EU-97019

Identifier Type: -

Identifier Source: secondary_id

CDR0000066438

Identifier Type: -

Identifier Source: org_study_id