NCT00003419

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1998

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

September 20, 2013

Status Verified

November 1, 2001

First QC Date

November 1, 1999

Last Update Submit

September 19, 2013

Conditions

Sarcoma

Keywords

AIDS-related Kaposi sarcoma

Outcome Measures

Primary Outcomes (1)

  • Efficacy

Interventions

antiviral therapyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Centro di Riferimento Oncologico - Aviano

Aviano, 33081, Italy

Location

MeSH Terms

Conditions

SarcomaAIDS-related Kaposi sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Umberto Tirelli, MD

    Centro di Riferimento Oncologico - Aviano

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

June 1, 1998

Last Updated

September 20, 2013

Record last verified: 2001-11

Locations

IT(1)