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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2001 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003419
First received: November 1, 1999
Last updated: September 19, 2013
Last verified: November 2001
  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:


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

Primary Outcome Measures:
  • Efficacy [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003419     History of Changes
Other Study ID Numbers: CDR0000066438, ITA-GICAT-POS2, EU-97019
Study First Received: November 1, 1999
Last Updated: September 19, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
AIDS-related Kaposi sarcoma

Additional relevant MeSH terms:
Sarcoma
Sarcoma, Kaposi
DNA Virus Infections
Herpesviridae Infections
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Vascular Tissue
Virus Diseases
Antiviral Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014