Liposomal Doxorubicin and Interleukin-12 in Treating Patients With AIDS-Related Kaposi's Sarcoma

DISEASE CHARACTERISTICS:

* Histologically confirmed Kaposi's sarcoma (KS)
* HIV positive
* Evaluable disease involving the skin and/or viscera

  * At least 5 lesions not previously treated with local therapy if restricted to the skin
  * Pulmonary lesions evaluable by CT scan
  * Gastrointestinal lesions evaluable by visualization or fiberoptic instrumentation
* Presence of at least one of the following indications for cytotoxic chemotherapy:

  * Pulmonary involvement
  * Visceral involvement
  * Pain
  * Edema
  * Ulcerating lesions
  * Decreased range of joint motion due to KS
  * Multiple lesions not amenable to local therapy
  * Lymphedema that impairs mobility or range of motion
  * Significant psychological impact leading to social withdrawal
* Progressive disease within the past 3 weeks while receiving a stable regimen of highly active antiretroviral therapy for at least 4 weeks unless there is a need for urgent chemotherapy
* Prior participation on this study allowed, provided patient was removed from study due to non-pancreatic hyperamylasemia and the following are true:

  * No dose-limiting toxicity by clinical and laboratory assessment
  * Pancreatic amylase portion normal by fractionated amylase
  * Lipase normal
  * No symptoms referable to the pancreas

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 30-100%

Life expectancy:

* More than 2 months

Hematopoietic:

* Hemoglobin at least 9.0 g/dL
* Absolute neutrophil count at least 750/mm\^3
* Platelet count at least 75,000/mm\^3

Hepatic:

* Bilirubin no greater than 3.8 mg/dL with direct fraction no greater than 0.3 mg/dL and indirect fraction no greater than 3.5 mg/dL if due to protease inhibitor therapy
* PT or aPTT no greater than 120% of control unless due to lupus-type anticoagulant
* AST no greater than 2.5 times upper limit of normal
* No prior hepatic cirrhosis
* No hepatic dysfunction

Renal:

* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance at least 60 mL/min

Cardiovascular:

* No congestive heart failure
* Ejection fraction at least 40% by MUGA or echocardiogram

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for 2 months after study participation
* No clinically significant autoimmune disease
* No active, gross gastrointestinal bleeding or uncontrolled peptic ulcer disease
* No prior inflammatory bowel disease
* No other prior or concurrent malignancy except squamous cell carcinoma in situ of the cervix or anus, completely resected basal cell carcinoma, or malignancy in complete remission for at least 1 year from the time a response was first documented
* No severe or life-threatening infection within the past 2 weeks
* No abnormality that would be scored as grade 3 toxicity except lymphopenia or direct manifestations of KS
* No known hypersensitivity to interleukin-12 (IL-12) or other compounds known to cross-react with IL-12
* No other medical condition that would preclude study entry

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* More than 2 weeks since prior cytokines or colony-stimulating factors other than epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF)
* No prior combination interleukin-12 and doxorubicin HCl liposome except for patients previously treated on this protocol who are being enrolled for paclitaxel salvage therapy
* No concurrent immunomodulatory agents
* No concurrent cytokines except epoetin alfa or G-CSF

Chemotherapy:

* See Disease Characteristics
* See Biologic therapy
* At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas)
* More 6 months since prior suramin
* No other concurrent cytotoxic chemotherapy

Endocrine therapy:

* More than 2 months since prior systemic glucocorticoid steroids at doses sufficient to affect immune response (e.g., more than 20 mg of prednisone for more than 1 week)
* Concurrent replacement glucocorticoid therapy allowed
* No other concurrent systemic glucocorticoid therapy

Radiotherapy:

* Not specified

Surgery:

* Not specified

Other:

* Concurrent antiretroviral therapy required
* No other concurrent anti-KS therapy