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

Primary Purpose

Sarcoma

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
antiviral therapy
Sponsored by
Centro di Riferimento Oncologico - Aviano
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring AIDS-related Kaposi sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro di Riferimento Oncologico - Aviano

Outcomes

Primary Outcome Measures

Efficacy

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
September 19, 2013
Sponsor
Centro di Riferimento Oncologico - Aviano
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1. Study Identification

Unique Protocol Identification Number
NCT00003419
Brief Title
Antiviral Therapy in Treating Patients With Slowly Progressing HIV-Related Kaposi's Sarcoma
Official Title
Treatment of HIV-Related Kaposi's Sarcoma and Stage I-III Slow-Proliferative Disease With Highly Active Antiretroviral Therapy (HAART)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2001
Overall Recruitment Status
Unknown status
Study Start Date
June 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centro di Riferimento Oncologico - Aviano

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
AIDS-related Kaposi sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
antiviral therapy
Primary Outcome Measure Information:
Title
Efficacy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Umberto Tirelli, MD
Organizational Affiliation
Centro di Riferimento Oncologico - Aviano
Official's Role
Study Chair
Facility Information:
Facility Name
Centro di Riferimento Oncologico - Aviano
City
Aviano
ZIP/Postal Code
33081
Country
Italy

12. IPD Sharing Statement

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

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