This trial is active, not recruiting.

Condition sarcoma
Treatment antiviral therapy
Phase phase 2
Sponsor Centro di Riferimento Oncologico - Aviano
Start date June 1998
Trial size 25 participants
Trial identifier NCT00003419, CDR0000066438, EU-97019, ITA-GICAT-POS2


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Primary purpose treatment

Primary Outcomes

time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Treatment of HIV-Related Kaposi's Sarcoma and Stage I-III Slow-Proliferative Disease With Highly Active Antiretroviral Therapy (HAART)
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).