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Treatment of HIV-Related Kaposi's Sarcoma and Stage I-III Slow-Proliferative Disease With Highly Active Antiretroviral Therapy (HAART)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Sarcoma

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Trial Information

Treatment of HIV-Related Kaposi's Sarcoma and Stage I-III Slow-Proliferative Disease With Highly Active Antiretroviral Therapy (HAART)


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Efficacy

Safety Issue:

No

Principal Investigator

Umberto Tirelli, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Centro di Riferimento Oncologico - Aviano

Authority:

United States: Federal Government

Study ID:

CDR0000066438

NCT ID:

NCT00003419

Start Date:

June 1998

Completion Date:

Related Keywords:

  • Sarcoma
  • AIDS-related Kaposi sarcoma
  • Sarcoma, Kaposi
  • Sarcoma

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