A Multicenter, Dose Escalating Study in Patients With Cutaneous AIDS-Related Kaposi's Sarcoma

Inclusion Criteria

DISEASE CHARACTERISTICS: Biopsy proven Kaposi's sarcoma that is stable or progressing
while receiving standard therapy HIV positive No severe pulmonary Kaposi's sarcoma Five
measurable lesions of at least 10 mm or lesions present for at least 30 days OR KS-related
generalized edema or edema of the extremities without evidence of active mucocutaneous
lesions

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 750/mm3
without transfusion Hemoglobin at least 8.0 g/dL without transfusion Platelet count at
least 50,000/mm3 without transfusion Hepatic: AST/ALT no greater than 2.5 times upper
limit of normal (ULN) Bilirubin no greater than 2.0 mg/dL (3.0 mg/dL if concurrent
indinavir therapy) Renal: Creatinine no greater than 1.8 mg/dL OR Creatinine clearance at
least 50 mL/min Other: Not pregnant Fertile patients must use effective contraception No
known allergy to Cremophor or Cremophor based drug product No concurrent uncontrolled
serious infection such as: Pneumocystis carinii pneumonia Toxoplasma brain abscess CMV
retinitis or colitis Cryptococcal meningitis Symptomatic Mycobacterium
avium-intracellulare No other active malignancy except: Basal cell carcinoma of the skin
Carcinoma in situ of the cervix No other acute or chronic medical or psychiatric condition

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior biologic therapy
for AIDS-related Kaposi's sarcoma At least 2 weeks since prior immunotherapy for
AIDS-related Kaposi's sarcoma and recovered At least 2 weeks since prior epoetin alfa,
filgrastim (G-CSF), or sargramostim (GM-CSF) No concurrent immunotherapy Chemotherapy: At
least 2 weeks since prior chemotherapy for AIDS-related Kaposi's sarcoma and recovered No
concurrent chemotherapy Endocrine therapy: At least 2 weeks since prior hormonal therapy
for AIDS-related Kaposi's sarcoma No concurrent hormonal therapy (including beta-HCG)
Radiotherapy: Recovered from prior radiotherapy No concurrent radiotherapy Surgery: At
least 4 weeks since prior surgery and recovered No prior biopsy of measurable lesion
Other: No prior laser therapy to measurable lesion Stable antiretroviral therapy for at
least 2 weeks At least 3 weeks since other investigational drugs No concurrent local or
topical therapy for disease No other concurrent investigational agents