RATIONALE: COL-3 may stop the growth of cancer by stopping blood flow to the tumor.

PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of COL-3 in treating patients who have HIV-related Kaposi's sarcoma.

OBJECTIVES:

• Compare the tumor response rate and duration of response in patients with HIV-related Kaposi's sarcoma treated with 2 different doses of COL-3.
• Determine the biologic activity of this drug by measuring the percent of apoptotic cells in tumor biopsies of these patients before and after study therapy.
• Determine the effect of this drug on the serum levels of matrix metalloproteinase (MMP)-2 and MMP-9 in these patients.
• Compare the safety and toxicity of these regimens in these patients.
• Evaluate the quality of life of patients treated with these regimens.
• Evaluate the relationship between clinical response and quantitative measures of Kaposi's sarcoma-associated herpes virus/human herpes virus-8 and HIV viral load in patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive low-dose oral COL-3 once daily.
• Arm II: Patients receive high-dose oral COL-3 once daily. Treatment on both arms continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed.

Patients are followed for at least 1 month.

PROJECTED ACCRUAL: A total of 70 patients (35 per treatment arm) will be accrued for this study within 1.75 years.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven Kaposi's sarcoma (KS) involving the skin, lymph nodes, oral cavity, gastrointestinal (GI) tract, and/or lungs
• GI or pulmonary involvement must be asymptomatic or minimally symptomatic
• At least 5 measurable, cutaneous lesions that can be used as indicator lesions
• HIV positive by ELISA, Western Blot, or other federally approved, licensed HIV test

PATIENT CHARACTERISTICS: Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 3 months

Hematopoietic:

• Hemoglobin at least 8.0 g/dL
• Absolute neutrophil count at least 750/mm^3
• Platelet count at least 75,000/mm^3
• No prior noniatrogenic bleeding disorder

Hepatic:

• AST and ALT no greater than 2.5 times upper limit of normal
• Total bilirubin normal (less than 3.5 mg/dL if elevation secondary to indinavir, and direct bilirubin normal)
• PT and PTT less than 1.2 times normal

Renal:

• Creatinine no greater than 1.5 mg/dL OR
• Creatinine clearance greater than 60 mL/min

Cardiovascular:

• No evidence of prior myocardial infarction or cardiac ischemia

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after study
• No active opportunistic infection

PRIOR CONCURRENT THERAPY: Biologic therapy:

• At least 4 weeks since prior blood products
• At least 2 weeks since prior filgrastim (G-CSF) or epoetin alfa

Chemotherapy:

• At least 3 weeks since prior antineoplastic treatment for KS and recovered
• No concurrent systemic chemotherapy for KS
• No concurrent systemic chemotherapy for other neoplasia

Endocrine therapy:

• Concurrent oral contraceptives, megestrol, or testosterone allowed

Radiotherapy:

• No prior radiotherapy to indicator lesions
• No concurrent radiotherapy for KS

Surgery:

• Not specified

Other:

• No prior local therapy to any KS indicator lesion unless there is clear evidence of progression
• At least 2 weeks since prior acute treatment for infection or other serious medical illness
• Prior highly active antiretroviral therapy (HAART) allowed
• Concurrent HAART allowed if on optimal, stable regimen for a minimum of 4 weeks before study
• Concurrent antipyretics, analgesics, allergy medications, antidepressants, or sleep medications allowed
• Concurrent vitamins, acupuncture, or visual techniques allowed
• No other concurrent investigational drugs
• No other concurrent therapy for KS
• No concurrent rifampin, phenytoin, or phenobarbital